This company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsDynavax Technologies（DYF1）株式概要ダイナバックス・テクノロジーズ・コーポレーションは商業段階のバイオ医薬品会社で、米国および国際的なワクチンの開発・商業化に注力している。 詳細DYF1 ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長4/6過去の実績0/6財務の健全性6/6配当金0/6報酬収益は年間42.59%増加すると予測されています リスク分析German市場と比較して、過去 3 か月間の株価の変動が非常に大きいすべてのリスクチェックを見るDYF1 Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€12.8139.4% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-159m733m2016201920222025202620282031Revenue US$593.1mEarnings US$107.8mAdvancedSet Fair ValueView all narrativesDynavax Technologies Corporation 競合他社BiotestSymbol: XTRA:BIO3Market cap: €1.4bBiotest GmbH KGaASymbol: HMSE:BIO0Market cap: €1.4bDextech MedicalSymbol: DB:LQ0Market cap: €185.8mFormyconSymbol: XTRA:FYBMarket cap: €367.6m価格と性能株価の高値、安値、推移の概要Dynavax Technologies過去の株価現在の株価US$12.8152週高値US$13.5752週安値US$7.65ベータ0.931ヶ月の変化-1.65%3ヶ月変化39.00%1年変化3.56%3年間の変化26.41%5年間の変化60.54%IPOからの変化-57.88%最新ニュースお知らせ • Feb 11Dynavax Technologies Corporation(NasdaqGS:DVAX) dropped from NASDAQ Composite IndexDynavax Technologies Corporation removedお知らせ • Feb 10+ 1 more updateSanofi (ENXTPA:SAN) completed the acquisition of Dynavax Technologies Corporation (NasdaqGS:DVAX).Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 23, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources. In case of termination Dynavax will pay $77.85 million and Sanofi will pay $116.77 million. As of January 12, 2025. the Offer will expire at one minute following 11:59 P.M., Eastern Time, on February 9, 2026, unless the Offer is extended by the Sanofi or earlier terminated. The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations, board of directors and shareholders approval. The deal has been unanimously approved by the board. The waiting period under the HSR Act expired, effective January 27, 2026. The acquisition is expected to close in the first quarter of 2026. Goldman Sachs & Co. LLC acted as a financial advisor and fairness opinion provider to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor and fairness opinion provider to Dynavax Technologies. Bill Roegge, Barbara Borden, Steve Przesmicki, Barbara Mirza, Austin Holt, David Burns and Jane Adams of Cooley LLP acted as a legal advisor to Dynavax Technologies. Jannelle Marie Seales, Xander Tabloff, Joseph M. Pari, Olivia J. Greer, John O'Loughlin, Antonia I. Tzinova, Shawn B. Cooley, John E. Scribner, Barbra J. Broudy, Kane Wishart, Paul J. Wessel, Christina A. De Vuono, Sachin Kohli and Michael J. Aiello of Weil, Gotshal & Manges LLP acted as legal advisor to Sanofi. Innisfree M&A Incorporated acted as information agent of Sanofi. Sanofi (ENXTPA:SAN) completed the acquisition of Dynavax Technologies Corporation (NasdaqGS:DVAX) on February 9, 2026. As of the Expiration Time, a total of 84,680,752 Shares had been validly tendered, representing approximately 73.92% of the aggregate number of shares outstanding. In connection with the merger, all Dynavax shares not validly tendered in the tender offer have been converted into the right to receive the same $15.5 per share in cash, without interest, subject to any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of February 10, 2026, Dynavax common stock will cease to be traded on the NASDAQ Global Select Stock Market. The minimum condition and all the other conditions to the offer have been satisfied, and on February 10, 2026, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.Board Change • Dec 30High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Director Lauren Silvernail was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.お知らせ • Dec 24Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion.Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 24, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources. The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations. The deal has been unanimously approved by the board. The acquisition is expected to close in the first quarter of 2026. Goldman Sachs & Co. LLC acted as a financial advisor to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor to Dynavax Technologies. Cooley LLP acted as a legal advisor to Dynavax Technologies.お知らせ • Nov 07Dynavax Technologies Corporation Reiterates Earnings Guidance for the Year 2025Dynavax Technologies Corporation reiterated earnings guidance for the year 2025. For the year, the company expects for HEPLISAV-B net product revenue to be in the range of $315 million to $325 million.お知らせ • Nov 06Dynavax Technologies Corporation (NasdaqGS:DVAX) announces an Equity Buyback for $100 million worth of its shares.Dynavax Technologies Corporation (NasdaqGS:DVAX) announced a share repurchase program. Under the program, the company will repurchase up to $100 million of its common stock. The program will reduce the company's cash reserves. The program does not have an expiration date, and company currently expects that purchases will be executed within a period of up to one year.最新情報をもっと見るRecent updatesお知らせ • Feb 11Dynavax Technologies Corporation(NasdaqGS:DVAX) dropped from NASDAQ Composite IndexDynavax Technologies Corporation removedお知らせ • Feb 10+ 1 more updateSanofi (ENXTPA:SAN) completed the acquisition of Dynavax Technologies Corporation (NasdaqGS:DVAX).Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 23, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources. In case of termination Dynavax will pay $77.85 million and Sanofi will pay $116.77 million. As of January 12, 2025. the Offer will expire at one minute following 11:59 P.M., Eastern Time, on February 9, 2026, unless the Offer is extended by the Sanofi or earlier terminated. The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations, board of directors and shareholders approval. The deal has been unanimously approved by the board. The waiting period under the HSR Act expired, effective January 27, 2026. The acquisition is expected to close in the first quarter of 2026. Goldman Sachs & Co. LLC acted as a financial advisor and fairness opinion provider to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor and fairness opinion provider to Dynavax Technologies. Bill Roegge, Barbara Borden, Steve Przesmicki, Barbara Mirza, Austin Holt, David Burns and Jane Adams of Cooley LLP acted as a legal advisor to Dynavax Technologies. Jannelle Marie Seales, Xander Tabloff, Joseph M. Pari, Olivia J. Greer, John O'Loughlin, Antonia I. Tzinova, Shawn B. Cooley, John E. Scribner, Barbra J. Broudy, Kane Wishart, Paul J. Wessel, Christina A. De Vuono, Sachin Kohli and Michael J. Aiello of Weil, Gotshal & Manges LLP acted as legal advisor to Sanofi. Innisfree M&A Incorporated acted as information agent of Sanofi. Sanofi (ENXTPA:SAN) completed the acquisition of Dynavax Technologies Corporation (NasdaqGS:DVAX) on February 9, 2026. As of the Expiration Time, a total of 84,680,752 Shares had been validly tendered, representing approximately 73.92% of the aggregate number of shares outstanding. In connection with the merger, all Dynavax shares not validly tendered in the tender offer have been converted into the right to receive the same $15.5 per share in cash, without interest, subject to any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of February 10, 2026, Dynavax common stock will cease to be traded on the NASDAQ Global Select Stock Market. The minimum condition and all the other conditions to the offer have been satisfied, and on February 10, 2026, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.Board Change • Dec 30High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Director Lauren Silvernail was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.お知らせ • Dec 24Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion.Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 24, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources. The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations. The deal has been unanimously approved by the board. The acquisition is expected to close in the first quarter of 2026. Goldman Sachs & Co. LLC acted as a financial advisor to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor to Dynavax Technologies. Cooley LLP acted as a legal advisor to Dynavax Technologies.お知らせ • Nov 07Dynavax Technologies Corporation Reiterates Earnings Guidance for the Year 2025Dynavax Technologies Corporation reiterated earnings guidance for the year 2025. For the year, the company expects for HEPLISAV-B net product revenue to be in the range of $315 million to $325 million.お知らせ • Nov 06Dynavax Technologies Corporation (NasdaqGS:DVAX) announces an Equity Buyback for $100 million worth of its shares.Dynavax Technologies Corporation (NasdaqGS:DVAX) announced a share repurchase program. Under the program, the company will repurchase up to $100 million of its common stock. The program will reduce the company's cash reserves. The program does not have an expiration date, and company currently expects that purchases will be executed within a period of up to one year.お知らせ • Oct 23Dynavax Technologies Corporation to Report Q3, 2025 Results on Nov 05, 2025Dynavax Technologies Corporation announced that they will report Q3, 2025 results After-Market on Nov 05, 2025お知らせ • Oct 22Dynavax Technologies Corporation Presents Positive Topline Data from Part 1 of Phase 1/2 Trial for Shingles Vaccine Candidate at IDWeek 2025 and Announces Initiation of Part 2 of TrialDynavax Technologies Corporation presented positive topline data from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, in a late-breaker session at IDWeek 2025. Dynavax also announced it has initiated Part 2 of the trial evaluating Z-1018 head-to-head versus Shingrix®? in older adults. Key highlights of the data presentation included: Z-1018 adjuvanted with CpG 1018 (with or without alum) showed favorable tolerability and strong humoral and cellular responses across a range of Dynavax-produced gE dosage levels and dosing intervals; Z-1018 groups elicited high anti-gE IgG concentrations, robust CD4+ T-cell frequencies, and VRRs (per IgG and CD4+ criteria) comparable to Shingrix, at 4 weeks after dose 2; In new data presented at IDWeek, Z-1018 induced a high proportion of polyfunctional CD4+ T-cell responses exhibiting multiple gE-specific activation markers, supporting the quality and breadth of the cellular immune response; Formulation consisting of 100 mcg gE adjuvanted with Cp G 1018 plus alum, administered at 0 and 8 weeks, was selected for advancement to Part 2 of the Phase 1/2 trial in which adults aged 70 years and older are being enrolled. Part 2 Study Initiated: Dynavax also announced that the first participants have been dosed in Part 2 of the Phase 1-2 clinical trial. Part 2 of the Phase 1 1/2 trial is a randomized, active-controlled, multicenter study expected to enroll approximately 324 healthy adults aged 70 years and older at trial sites in Australia and New Zealand. The study is designed to further characterize immunogenicity, safety, and tolerability at the selected Z-1018 dose and regimen, including demonstrating non-inferiority to Shingrix on select immunogenicity measures. Dynavax anticipates reporting topline Part 2 immunogenicity and safety data in the second half of 2026.お知らせ • Oct 16Dynavax Technologies Corporation Announces Executive ChangesIn connection with an internal realignment of various management roles and responsibilities, on October 15, 2025, the Board of Directors (Board) of Dynavax Technologies Corporation (Company) approved the transition of David F. Novack from his roles as the company’s President and Chief Operating Officer to his new roles as Senior Vice President and Chief Operating Officer, effective January 1, 2026. The Board also approved the removal of Robert Janssen, M.D.’s roles as Chief Medical Officer and Senior Vice President, Clinical Development, Medical and Regulatory Affairs, effective upon the earlier to occur of (a) the date the Company employs a new Chief Medical Officer and (b) March 2, 2026, and further approved the conclusion of Dr. Janssen’s employment as of March 2, 2026. The Company has commenced a search process for a successor Chief Medical Officer.お知らせ • Aug 21Dynavax Technologies Corporation Announces Positive Topline Phase 1/2 Results Supporting Potential Best-In-Class Shingles Vaccine ProfileDynavax Technologies Corporation announced positive topline results from Part 1 of its randomized, observer-blinded, and active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, head-to-head versus Shingrix in participants aged 50 to 69 years. Based on these results, Dynavax intends to advance Z-1018 into Part 2 of the Phase 1/2 program in adults 70 years of age and older, expected to initiate in the second half of 2025. In Part 1 of the trial at one month after the second vaccine dose, Z-1018 demonstrated antibody and CD4+ T cell vaccine responses similar to those observed in the comparator arm receiving Shingrix, the currently licensed shingles vaccine, with a favorable tolerability profile. At the dose formulation and regimen chosen for advancement to Part 2 of the trial, 12.5% of participants receiving Z-1018 reported grade 2 or 3 local PIRs and 27.5% reported grade 2 or 3 systemic PIRs, versus 52.6% and 63.2% for Shingrix, respectively. No safety concerns have been identified in this ongoingblinded study that has oversight by a safety monitoring committee.お知らせ • Jul 30Dynavax Technologies Corporation to Report Q2, 2025 Results on Aug 07, 2025Dynavax Technologies Corporation announced that they will report Q2, 2025 results After-Market on Aug 07, 2025お知らせ • Jun 30+ 5 more updatesDynavax Technologies Corporation(NasdaqGS:DVAX) dropped from Russell 2500 Value IndexDynavax Technologies Corporation(NasdaqGS:DVAX) dropped from Russell 2500 Value Indexお知らせ • Jun 10Deep Track Capital Sends Letter to Shareholders of Dynavax TechnologiesOn June 9, 2025, Deep Track Capital, LP issued a letter to shareholders detailing the benefits of electing Dynavax Technologies Corporation’s 4 nominees – Brett Erkman, Jeffrey Farrow, Michael Mullette, and Donald Santel – to the Board of Directors at the upcoming 2025 annual meeting of shareholders on June 11, 2025. Deep Track’s nominees are prepared to collectively enter the boardroom with open-minded perspectives, constructive approach and sole focus on creating value for all shareholders. Deep Track Capital expressed its views that without meaningful Board change ‘valid and critical questions regarding the Company’s strategic direction, capital allocation, and Board responsiveness’ will remain unanswered. Deep Track Capital details urgent need to address Company’s consistent failure to achieve stated targets and reverse heplisav market share stagnation.お知らせ • May 20Deep Track Capital Posts Investor Presentation to its Campaign WebsiteOn May 19, 2025, Deep Track Capital, LP posted supplemental investor presentation to its campaign website at www.RefocusDVAX.com related to Dynavax Technologies Corporation.お知らせ • May 16Deep Track Capital Issues Letter to Fellow Shareholders of Dynavax TechnologiesOn May 15, 2025, Deep Track Capital, LP issued a letter to shareholders in connection with its nomination of 4 candidates, Brett Erkman, Jeffrey Farrow, Donald Santel, and Michael Mullette for election to Dynavax Technologies Corporation’s Board of Directors at the 2025 annual meeting of stockholders.お知らせ • May 13Deep Track Capital Sends Letter to Shareholders of Dynavax Technologies CorporationOn May 12, 2025, Deep Track Capital, LP sent a letter to shareholders of Dynavax Technologies Corporation urging the shareholders to vote for its nominees, Brett Erkman, Jeffrey Farrow, Michael Mullette, and Donald Santel, on the white proxy card at the Company’s annual shareholders meeting.お知らせ • May 07Dynavax Technologies Corporation Reaffirms Earnings Guidance for the Full Year 2025Dynavax Technologies Corporation reaffirmed earnings guidance for the full year 2025. For the full year 2025, the company expects HEPLISAV-B net product revenue is expected in the range of $305 to $325 million.お知らせ • Apr 23Dynavax Technologies Corporation to Report Q1, 2025 Results on May 06, 2025Dynavax Technologies Corporation announced that they will report Q1, 2025 results After-Market on May 06, 2025お知らせ • Apr 22Deep Track Capital Files Definitive Proxy Statement and Sends Letter to Fellow ShareholdersOn April 21, 2025, Deep Track Capital, LP announced that it has filed a definitive proxy statement in connection with its nomination of 4 candidates for election to Dynavax Technologies Corporation’s Board of Directors at the 2025 annual meeting of stockholders. Deep Track also sent a letter to shareholders expressing the Company’s misguided acquisition strategy is destroying value and preventing the Company from maximizing the opportunities of heplisav for shareholders and patients.お知らせ • Apr 18Dynavax Technologies Corporation, Annual General Meeting, Jun 11, 2025Dynavax Technologies Corporation, Annual General Meeting, Jun 11, 2025.お知らせ • Apr 16Deep Track Capital Comments on Dynavax Technologies’ Rejection of Settlement OfferOn April 16, 2025, Deep Track Capital LP Commented on the Dynavax Technologies Corporation’s disclosure that the Board of Directors has rejected a settlement proposal in connection with its nomination of 4 candidates for election to the Board at the 2025 annual meeting of shareholders. Deep Track Capital proposed a 3-part proposal to the Company, that 1) Deep Track nominees Brett Erkman and Donald Santel would be appointed to the Board, 2) 2 long-tenured incumbent directors would step down; and 3) the Board would rebalance its classes such that there are 3 directors in each, and it is designed to ensure that a shareholder representative would be in the boardroom and to avoid a proxy contest, and the Company ejected this proposed settlement, and merely reiterated a prior proposal that it has now put forth for a third time. Deep Track criticized the Board's unwillingness to compromise, emphasized the need for investor-driven change and representation in the boardroom, and highlighted its commitment to protecting shareholders' interests and ensuring their voices are heard. Further, Deep Track stated that it remains open to discussions around how to resolve this situation in an amicable fashion, it is committed to protecting the best interests of all Company shareholders and ensuring their voices are heard.お知らせ • Mar 10Deep Track Capital Sends Letter to Dynavax Technologies’ Board of DirectorsOn March 10, 2025, Deep Track Capital LP announced that it has sent a letter to Dynavax Technologies Corporation’s board of directors, stating that investor feedback supporting its course of action and sharing concerns with company’s capital allocation strategy, poor governance, and lack of shareholder perspective in the boardroom, and there is a desire for a shareholder representative on the Board. Deep Track criticizes the Board for obstructing shareholder rights and mischaracterizing its intentions and highlighted the Company’s refusal to reach a constructive resolution and calls on board to stop engaging in Petty defense tactics, Deep Track questions the issuance of expensive convertible notes instead of using cash on hand and mentioned that the recent refinancing decision is seen as unsophisticated and costly. Deep Track emphasizes the need for new directors to drive strategic improvements and stating that its actions are not about taking control but ensuring better governance and shareholder representation.お知らせ • Mar 07Dynavax Technologies Corporation announced that it expects to receive $39.7 million in fundingDynavax Technologies Corporation entered into subscription agreement for issuance of 2.50% Convertible Senior Notes due 2026 for gross proceeds of $39.7 million on March 5, 2025. The transaction is expected to close on or about March 13, 2025, subject to customary closing conditions. The New Notes will be issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The Company is relying on this exemption from registration based in part on representations made by the investors in the New Notes in the Exchange and Subscription Agreements.お知らせ • Feb 21Dynavax Technologies Corporation Provides Revenue Guidance for the Full Year 2025Dynavax Technologies Corporation provided revenue guidance for the full year 2025. For the year, the company expects HEPLISAV-B net product revenue is expected in the range of $305 million to $325 million.お知らせ • Feb 08Dynavax Technologies Corporation Announces Principal Accounting Officer ChangesOn February 3, 2025, Justin Burgess notified Dynavax Technologies Corporation (the “Company”) that he intends to resign from the Company, including his position as the Company’s principal accounting officer, on or about March 3, 2025. The Company intends to appoint Kelly MacDonald, the Company’s Chief Financial Officer and principal financial officer, as the Company’s principal accounting officer, prior to March 3, 2025. There are no arrangements or understandings between Ms. MacDonald and any other persons in connection with Ms. MacDonald’s appointment as a principal accounting officer.お知らせ • Feb 07Dynavax Technologies Corporation to Report Q4, 2024 Results on Feb 20, 2025Dynavax Technologies Corporation announced that they will report Q4, 2024 results After-Market on Feb 20, 2025お知らせ • Jan 28Dynavax Technologies Corporation Announces Board ChangesDynavax Technologies Corporation announced the following changes to its Board of Directors as part of its ongoing refreshment program: Emilio Emini, Ph.D. and Lauren Silvernail have been appointed to the Board, effective February 3, 2025. Dr. Emini will serve as a Class III director with an initial term expiring at the Company's 2027 Annual Meeting and Ms. Silvernail will serve as a Class I director with an initial term expiring at the Company's 2025 Annual Meeting. Peggy Phillips, who has served on the Dynavax Board since 2006, will retire from the Board at the 2025 Annual Meeting. Julie Eastland will step down from the Board at the 2025 Annual Meeting given her recent appointment as chief executive officer of another public company. Dr. Emini brings over 40 years of experience as an executive and academic across the biopharmaceutical industry and global public health roles, helping to develop and deliver multiple anti-infectious disease interventions. Prior to his retirement, Dr. Emini served as Chief Executive Officer of the Bill & Melinda Gates Medical Research Institute and as the Director of the Foundation's Tuberculosis and HIV Programs. At the Merck Research Laboratories, from 1983 to 2004, Dr. Emini led the biological research that developed the first highly active antiretroviral therapies for HIV and led multiple vaccine research teams that contributed to many successful developments, including the vaccines for human papillomavirus and rotavirus. Following a two-year leave from the industry at the International AIDS Vaccine Initiative, Dr. Emini joined Wyeth/Pfizer as the Senior Vice President of Vaccine R&D where he led the development of the Prevenar 13® vaccine for prevention of pneumococcal disease. Dr. Emini holds a Bachelor of Science from Manhattan College and a Ph.D. in Microbiology from the Cornell University Graduate School of Medicine. Ms. Silvernail has three decades of experience leading finance and business development functions across the pharmaceutical industry. She most recently served as Chief Financial Officer and Executive Vice President of Corporate Development of Evolus Inc., from 2018 until her retirement in 2022, where she led fundraising, financial and partnership activities including establishing the infrastructure for the U.S. commercial launch of the company's first approved product. Previously, she served as Chief Financial Officer and Chief Business Officer at Revance Therapeutics Inc., where she led the company's initial public offering and subsequent rounds of financing. Prior to that, Ms. Silvernail was Chief Financial Officer and Executive Vice President of Corporate Development at ISTA Pharmaceuticals until its sale to Bausch & Lomb. Prior to that, she held corporate development roles at Allergan and other companies. Ms. Silvernail is currently a director and Audit Committee Chair of Harrow and previously served as a director and Audit Committee Chair at Harpoon Therapeutics until its successful sale to Merck and a director and Corporate Governance Committee chair at Nicox S.A. She earned an M.B.A. in finance and accounting from the Anderson Graduate School of Management at UCLA, and a B.A. in Biophysics from the University of California, Berkeley.Reported Earnings • Nov 08Third quarter 2024 earnings released: EPS: US$0.13 (vs US$0.11 in 3Q 2023)Third quarter 2024 results: EPS: US$0.13 (up from US$0.11 in 3Q 2023). Revenue: US$80.6m (up 16% from 3Q 2023). Net income: US$17.6m (up 23% from 3Q 2023). Profit margin: 22% (up from 21% in 3Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 33% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings.お知らせ • Nov 08+ 1 more updateDynavax Technologies Corporation (NasdaqGS:DVAX) announces an Equity Buyback for $200 million worth of its shares.Dynavax Technologies Corporation (NasdaqGS:DVAX) announced a share repurchase program. Under the program, the company will repurchase up to $200 million of its common stock. The program will reduce the company's cash reserves. The program does not have an expiration date, and purchases are expected to be executed within a period of up to one year.お知らせ • Oct 25Dynavax Technologies Corporation to Report Q3, 2024 Results on Nov 07, 2024Dynavax Technologies Corporation announced that they will report Q3, 2024 results After-Market on Nov 07, 2024Reported Earnings • Aug 07Second quarter 2024 earnings released: EPS: US$0.087 (vs US$0.027 in 2Q 2023)Second quarter 2024 results: EPS: US$0.087 (up from US$0.027 in 2Q 2023). Revenue: US$73.8m (up 23% from 2Q 2023). Net income: US$11.4m (up 232% from 2Q 2023). Profit margin: 15% (up from 5.7% in 2Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 8% per year whereas the company’s share price has fallen by 3% per year.お知らせ • Jul 24Dynavax Technologies Corporation to Report Q2, 2024 Results on Aug 06, 2024Dynavax Technologies Corporation announced that they will report Q2, 2024 results After-Market on Aug 06, 2024お知らせ • Jun 28Dynavax Technologies Corporation Initiates Phase 1/2 Study of Novel Shingles Vaccine ProgramDynavax Technologies Corporation announced that the first participant has been dosed in a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018, the company's investigational vaccine candidate being developed for the prevention of shingles (herpes zoster), a debilitating disease caused by the varicella-zoster virus. The Phase 1/2 randomized, active-controlled, dose escalation, multicenter trial is expected to enroll approximately 440 healthy adults aged 50 to 69 years at trial sites in Australia, and will evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix®. Key objectives of the trial include selecting the optimal glycoprotein E (gE) protein dose level and dosing schedule for further clinical development. The Phase 1/2 trial will be used to support validation of a Patient Reported Outcome measurement tool to differentiate Z-1018 on tolerability and to support potential label claims. Dynavax anticipates reporting top line immunogenicity and safety data in the second half of 2025, including a comparison of CD4+ T-cells one month after the second of two vaccine doses.お知らせ • May 15Dynavax Technologies Corporation Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.SDynavax Technologies Corporation provided a regulatory update for the company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on Hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of effectiveness or safety of a four-dose regimen of HEPLISAV-B. The CRL has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which is for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CRL also does not affect the approval decision received from the European Commission in October 2023 for the four-dose HEPLIS AV-B regimen for the adult hemodialysis population. The sBLA was comprised of clinical immunogenicity and safety data from the Phase 1 HBV-24 study of a four-dose regimen. The CRL stated that the data from HBV-24 were insufficient due to the destruction of data source documents by a third-party clinical trial site operator for approximately half of the subjects enrolled in the trial. In addition, the total number of subjects in the single-arm HBV-24 study was deemed to be insufficient to evaluate safety of the four-dose regimen. Important U.S. Product Information: HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. Important U.S. Safety Information (ISI): Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast; Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B; Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B; Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration; The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).お知らせ • May 10Dynavax Technologies Corporation Reaffirms Financial Guidance for the Full Year 2024Dynavax Technologies Corporation reaffirmed financial guidance for the full year 2024. For the year, the company expects HEPLISAV-B net product revenue between approximately $265 million - $280 million, including approximately $3 million in ex-U.S. sales through commercialization partnership in Germany.Reported Earnings • May 09First quarter 2024 earnings released: US$0.067 loss per share (vs US$0.19 loss in 1Q 2023)First quarter 2024 results: US$0.067 loss per share (improved from US$0.19 loss in 1Q 2023). Revenue: US$50.8m (up 8.2% from 1Q 2023). Net loss: US$8.72m (loss narrowed 64% from 1Q 2023). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 24% per year whereas the company’s share price has increased by 22% per year.お知らせ • Apr 26Dynavax Technologies Corporation to Report Q1, 2024 Results on May 08, 2024Dynavax Technologies Corporation announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 08, 2024お知らせ • Apr 12Dynavax Technologies Corporation, Annual General Meeting, May 23, 2024Dynavax Technologies Corporation, Annual General Meeting, May 23, 2024, at 09:00 Pacific Standard Time. Agenda: To consider and elect our three nominees for Class III directors to hold office until the 2027 Annual Meeting of Stockholders or until their respective successors are duly elected and qualified; to consider and approve the amendment and restatement of the Dynavax Technologies Corporation 2018 Equity Incentive Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 11,400,000; to consider and approve, on an advisory basis, the compensation of the Company’s named executive officers, as disclosed in the proxy statement accompanying this Notice; and to transact such other business matters.New Risk • Feb 24New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.3% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company.Reported Earnings • Feb 23Full year 2023 earnings released: US$0.05 loss per share (vs US$2.32 profit in FY 2022)Full year 2023 results: US$0.05 loss per share (down from US$2.32 profit in FY 2022). Revenue: US$232.3m (down 68% from FY 2022). Net loss: US$6.39m (down 102% from profit in FY 2022). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 54% per year but the company’s share price has only increased by 13% per year, which means it is significantly lagging earnings growth.お知らせ • Feb 23Dynavax Technologies Corporation Provides Revenue Guidance for the Year 2024Dynavax Technologies Corporation provided revenue guidance for the year 2024. The company expects HEPLISAV-B net product revenue between approximately $265 million - $280 million, including approximately $3 million in ex-U.S. sales through commercialization agreement with Bavarian Nordic in Germany.お知らせ • Feb 09Dynavax Technologies Corporation to Report Q4, 2023 Results on Feb 22, 2024Dynavax Technologies Corporation announced that they will report Q4, 2023 results After-Market on Feb 22, 2024お知らせ • Nov 03Dynavax Technologies Corporation Revises Earnings Guidance for the Full Year 2023Dynavax Technologies Corporation revised earnings guidance for the full year 2023. For the year, the company expects HEPLISAV-B net product revenuebetween approximately $210 million - $220 million, compared to the prior range of approximately $200 million - $215 million.Reported Earnings • Nov 03Third quarter 2023 earnings released: EPS: US$0.11 (vs US$0.50 in 3Q 2022)Third quarter 2023 results: EPS: US$0.11 (down from US$0.50 in 3Q 2022). Revenue: US$69.5m (down 59% from 3Q 2022). Net income: US$14.3m (down 78% from 3Q 2022). Profit margin: 21% (down from 38% in 3Q 2022). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 83% per year but the company’s share price has only increased by 55% per year, which means it is significantly lagging earnings growth.お知らせ • Oct 27Dynavax Technologies Corporation to Report Q3, 2023 Results on Nov 02, 2023Dynavax Technologies Corporation announced that they will report Q3, 2023 results After-Market on Nov 02, 2023Reported Earnings • Aug 04Second quarter 2023 earnings released: EPS: US$0.027 (vs US$1.02 in 2Q 2022)Second quarter 2023 results: EPS: US$0.027 (down from US$1.02 in 2Q 2022). Revenue: US$60.2m (down 77% from 2Q 2022). Net income: US$3.43m (down 97% from 2Q 2022). Profit margin: 5.7% (down from 50% in 2Q 2022). Revenue is forecast to grow 6.7% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 105% per year but the company’s share price has only increased by 22% per year, which means it is significantly lagging earnings growth.お知らせ • Jul 23Dynavax Technologies Corporation to Report Q2, 2023 Results on Aug 03, 2023Dynavax Technologies Corporation announced that they will report Q2, 2023 results After-Market on Aug 03, 2023Recent Insider Transactions • May 08President & COO recently sold €174k worth of stockOn the 4th of May, David Novack sold around 18k shares on-market at roughly €9.91 per share. This transaction amounted to 85% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. David has been a net seller over the last 12 months, reducing personal holdings by €819k.お知らせ • May 04Dynavax Technologies Corporation Reaffirms Revenue Guidance for the Year 2023Dynavax Technologies Corporation reaffirmed revenue guidance for the year 2023. The company is reaffirming HEPLISAV-B net product revenue guidance for full year 2023 of between $165–$185 million, representing annual revenue growth of 30%-47%.Reported Earnings • May 03First quarter 2023 earnings released: US$0.19 loss per share (vs US$0.26 profit in 1Q 2022)First quarter 2023 results: US$0.19 loss per share (down from US$0.26 profit in 1Q 2022). Revenue: US$46.9m (down 59% from 1Q 2022). Net loss: US$24.3m (down 174% from profit in 1Q 2022). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 118% per year but the company’s share price has only increased by 36% per year, which means it is significantly lagging earnings growth.Reported Earnings • Feb 24Full year 2022 earnings released: EPS: US$2.32 (vs US$0.62 in FY 2021)Full year 2022 results: EPS: US$2.32 (up from US$0.62 in FY 2021). Revenue: US$722.7m (up 65% from FY 2021). Net income: US$293.2m (up 306% from FY 2021). Profit margin: 41% (up from 17% in FY 2021). The increase in margin was driven by higher revenue. Revenue is expected to decline by 11% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 18%. Over the last 3 years on average, earnings per share has increased by 123% per year but the company’s share price has only increased by 41% per year, which means it is significantly lagging earnings growth.お知らせ • Feb 10Dynavax Technologies Corporation to Report Q4, 2022 Results on Feb 23, 2023Dynavax Technologies Corporation announced that they will report Q4, 2022 results at 4:00 PM, US Eastern Standard Time on Feb 23, 2023Recent Insider Transactions • Nov 16President & COO recently sold €646k worth of stockOn the 8th of November, David Novack sold around 52k shares on-market at roughly €12.37 per share. This transaction amounted to 96% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was David's only on-market trade for the last 12 months.Reported Earnings • Nov 05Third quarter 2022 earnings released: EPS: US$0.50 (vs US$0.24 loss in 3Q 2021)Third quarter 2022 results: EPS: US$0.50 (up from US$0.24 loss in 3Q 2021). Revenue: US$167.7m (up 57% from 3Q 2021). Net income: US$63.8m (up US$92.2m from 3Q 2021). Profit margin: 38% (up from net loss in 3Q 2021). The move to profitability was primarily driven by higher revenue. Revenue is expected to decline by 16% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 21%. Over the last 3 years on average, earnings per share has increased by 119% per year but the company’s share price has only increased by 50% per year, which means it is significantly lagging earnings growth.お知らせ • Nov 04Dynavax Technologies Corporation Provides Revenue Guidance for the Year 2022Dynavax Technologies Corporation provided revenue guidance for the year 2022. The company anticipates 2022 revenues, operating expenses, and other costs to be in the ranges shown below, consistent with the Company's previous financial guidance provided on August 4, 2022: Full-year CpG 1018 adjuvant net product revenues of between $550 million and $600 million.お知らせ • Oct 21Dynavax Technologies Corporation to Report Q3, 2022 Results on Nov 03, 2022Dynavax Technologies Corporation announced that they will report Q3, 2022 results After-Market on Nov 03, 2022お知らせ • Sep 13Dynavax Technologies Corporation Announces First Participant Dosed in A Phase 2 Clinical Trial Evaluating an Adjuvanted Plague VaccineDynavax Technologies Corporation in collaboration with the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and supported by the DOD's Chemical and Biological Defense Program announced that the first participant has been dosed in a Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability of the JPEO-CBRND's Recombinant Plague (rF1V) vaccine combined with Dynavax's CpG 1018®adjuvant, in adults 18 to 55 years of age. As previously announced, Dynavax and the DOD executed an agreement which provides for approximately $22 million in funding over two and a half years to develop an improved recombinant plague vaccine adjuvanted with CpG 1018 adjuvant. Under the agreement, Dynavax will conduct a Phase 2 clinical trial combining its CpG 1018 adjuvant with the DOD's rF1V vaccine. The trial is assessing a two-dose regimen administered over one month. Previous clinical studies of the rF1V, not including CpG 1018 adjuvant, have evaluated a three-dose regimen over six months. Any future commercial supply agreements would be subject to a separate agreement between Dynavax and the U.S government.Valuation Update With 7 Day Price Move • Aug 25Investor sentiment deteriorated over the past weekAfter last week's 17% share price decline to €11.48, the stock trades at a forward P/E ratio of 13x. Average forward P/E is 22x in the Biotechs industry in Europe. Total returns to shareholders of 333% over the past three years.Valuation Update With 7 Day Price Move • Aug 11Investor sentiment improved over the past weekAfter last week's 21% share price gain to €16.50, the stock trades at a forward P/E ratio of 20x. Average forward P/E is 25x in the Biotechs industry in Europe. Total returns to shareholders of 522% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €18.23 per share.Reported Earnings • Aug 05Second quarter 2022 earnings released: EPS: US$1.02 (vs US$0.039 in 2Q 2021)Second quarter 2022 results: EPS: US$1.02 (up from US$0.039 in 2Q 2021). Revenue: US$256.5m (up 386% from 2Q 2021). Net income: US$128.8m (up US$124.3m from 2Q 2021). Profit margin: 50% (up from 8.5% in 2Q 2021). The increase in margin was driven by higher revenue. Over the next year, revenue is expected to shrink by 15% compared to a 31% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 107% per year but the company’s share price has only increased by 72% per year, which means it is significantly lagging earnings growth.お知らせ • Aug 05Dynavax Technologies Corporation Revises Earnings Guidance for the Year 2022Dynavax Technologies Corporation revised earnings guidance for the year 2022. The Company now expects 2022 full-year CpG 1018 adjuvant COVID-19 supply revenue to be between $550 million and $600 million, based on committed orders, with an anticipated full-year gross margin of approximately 60%.お知らせ • Jul 22Dynavax Technologies Corporation to Report Q2, 2022 Results on Aug 04, 2022Dynavax Technologies Corporation announced that they will report Q2, 2022 results After-Market on Aug 04, 2022Valuation Update With 7 Day Price Move • Jul 08Investor sentiment improved over the past weekAfter last week's 21% share price gain to €14.09, the stock trades at a forward P/E ratio of 15x. Average forward P/E is 31x in the Biotechs industry in Europe. Total returns to shareholders of 327% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €19.25 per share.Valuation Update With 7 Day Price Move • Jun 15Investor sentiment deteriorated over the past weekAfter last week's 18% share price decline to €9.67, the stock trades at a forward P/E ratio of 10x. Average forward P/E is 31x in the Biotechs industry in Europe. Total returns to shareholders of 178% over the past three years.Valuation Update With 7 Day Price Move • May 18Investor sentiment improved over the past weekAfter last week's 21% share price gain to €9.22, the stock trades at a forward P/E ratio of 12x. Average forward P/E is 33x in the Biotechs industry in Europe. Total returns to shareholders of 60% over the past three years.お知らせ • May 08Dynavax Technologies Corporation Reaffirms Earnings Guidance for the Year 2022Dynavax Technologies Corporation reaffirmed earnings guidance for the year 2022. For the full-year CpG 1018 adjuvant net product revenues of at least $550 million, with an associated gross margin of approximately 50%.Reported Earnings • May 07First quarter 2022 earnings released: EPS: US$0.26 (vs US$0.007 in 1Q 2021)First quarter 2022 results: EPS: US$0.26 (up from US$0.007 in 1Q 2021). Revenue: US$114.0m (up 37% from 1Q 2021). Net income: US$32.9m (up US$32.0m from 1Q 2021). Profit margin: 29% (up from 1.0% in 1Q 2021). The increase in margin was primarily driven by higher revenue. Over the next year, revenue is forecast to grow 29%, compared to a 37% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 90% per year but the company’s share price has only increased by 12% per year, which means it is significantly lagging earnings growth.お知らせ • Apr 22Dynavax Technologies Corporation to Report Q1, 2022 Results on May 05, 2022Dynavax Technologies Corporation announced that they will report Q1, 2022 results After-Market on May 05, 2022お知らせ • Apr 15Dynavax Technologies Corporation, Annual General Meeting, May 26, 2022Dynavax Technologies Corporation, Annual General Meeting, May 26, 2022, at 09:00 Pacific Standard Time. Agenda: To elect our five nominees for Class I directors to hold office until the 2025 Annual Meeting of Stockholders or until their respective successors are duly elected and qualified; To approve the amendment and restatement of the Dynavax Technologies Corporation 2018 Equity Incentive Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 15,000,000; To approve, on an advisory basis, the compensation of the Company's named executive officers, as disclosed in the proxy statement accompanying this Notice; and to ratify the selection of Ernst & Young LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2022.Valuation Update With 7 Day Price Move • Mar 09Investor sentiment deteriorated over the past weekAfter last week's 18% share price decline to €8.85, the stock trades at a forward P/E ratio of 8x. Average forward P/E is 38x in the Biotechs industry in Europe. Total returns to shareholders of 14% over the past three years.Reported Earnings • Mar 02Full year 2021 earnings: EPS in line with expectations, revenues disappointFull year 2021 results: EPS: US$0.70 (up from US$0.75 loss in FY 2020). Revenue: US$439.4m (up US$392.9m from FY 2020). Net income: US$81.3m (up US$156.5m from FY 2020). Profit margin: 19% (up from net loss in FY 2020). The move to profitability was driven by higher revenue. Revenue missed analyst estimates by 2.2%. Over the next year, revenue is forecast to grow 60%, compared to a 64% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 75% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth.お知らせ • Mar 02Dynavax Technologies Corporation Provides Revenue Guidance for the Full Year 2022Dynavax Technologies Corporation provided revenue guidance for the Full Year 2022. For the year, the company expected CpG 1018 adjuvant net product revenues of at least $550 million, with associated gross margin of approximately 50%.お知らせ • Feb 17Dynavax Technologies Corporation to Report Q4, 2021 Results on Feb 28, 2022Dynavax Technologies Corporation announced that they will report Q4, 2021 results After-Market on Feb 28, 2022Breakeven Date Change • Dec 31Forecast breakeven date pushed back to 2022The 4 analysts covering Dynavax Technologies previously expected the company to break even in 2021. New consensus forecast suggests the company will make a profit of US$234.9m in 2022.Reported Earnings • Nov 06Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.04 profit in 3Q 2020)The company reported a decent third quarter result with improved revenues, although earnings and control over costs were weaker. Third quarter 2021 results: Revenue: US$108.3m (up US$94.9m from 3Q 2020). Net loss: US$28.4m (down US$32.8m from profit in 3Q 2020). Over the last 3 years on average, earnings per share has increased by 57% per year but the company’s share price has only increased by 7% per year, which means it is significantly lagging earnings growth.Breakeven Date Change • Sep 23Forecast to breakeven in 2021The 5 analysts covering Dynavax Technologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$54.2m in 2021.お知らせ • Aug 25Medigen Vaccine Biologics Corporation and Dynavax Technologies Corporation Announces Launch of Its Covid-19 Vaccine Mvc-Cov1901 Adjuvanted with Dynavax's Cpg 1018 AdjuvantMedigen Vaccine Biologics Corporation, and Dynavax Technologies Corporation announced the rollout of its COVID-19 vaccine, MVC-COV1901. Approximately 600,000 people are anticipated to receive the Medigen vaccine this week. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax and aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by the U.S.NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). MVC-COV1901 vaccine's Phase 1 and 3,815-participant Phase 2 clinical study data has shown robust safety and promising immunogenicity responses and as a result obtained Taiwan's EUA approval on July 19th, 2021. MVC will continue to collaborate with international partners for phase 3 clinical trial development and assist the global community in its fight against the COVID-19 pandemic.Reported Earnings • Aug 06Second quarter 2021 earnings released: EPS US$0.039 (vs US$0.53 loss in 2Q 2020)The company reported a strong second quarter result with improved earnings, revenues and profit margins. Second quarter 2021 results: Revenue: US$52.8m (up US$50.1m from 2Q 2020). Net income: US$4.47m (up US$56.1m from 2Q 2020). Profit margin: 8.5% (up from net loss in 2Q 2020). Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings.Board Change • Jul 31High number of new directorsIndependent Director Julie Eastland was the last director to join the board, commencing their role in 2020.お知らせ • Jun 28+ 2 more updatesDynavax Technologies Corporation(NasdaqCM:DVAX) dropped from Russell 3000E Value IndexDynavax Technologies Corporation(NasdaqCM:DVAX) dropped from Russell 3000E Value IndexReported Earnings • May 08First quarter 2021 earnings released: EPS US$0.008 (vs US$0.15 loss in 1Q 2020)The company reported a strong first quarter result with improved earnings, revenues and profit margins. First quarter 2021 results: Revenue: US$83.3m (up US$72.4m from 1Q 2020). Net income: US$891.0k (up US$13.5m from 1Q 2020). Profit margin: 1.1% (up from net loss in 1Q 2020). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 30% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings.Reported Earnings • Feb 27Full year 2020 earnings released: US$0.75 loss per share (vs US$2.16 loss in FY 2019)The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: US$46.6m (up 32% from FY 2019). Net loss: US$75.2m (loss narrowed 52% from FY 2019). Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings.Analyst Estimate Surprise Post Earnings • Feb 27Revenue beats expectationsRevenue exceeded analyst estimates by 16%. Over the next year, revenue is forecast to grow 409%, compared to a 52% growth forecast for the Biotechs industry in Germany.お知らせ • Feb 20Dynavax Technologies Corporation Announces European Commission Marketing Authorization for HEPLISAV B®, a 2 Dose Adult Hepatitis B Adjuvanted VaccineDynavax Technologies Corporation announced that the European Commission (EC) has granted Marketing Authorization for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The approval was issued following the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion on the company's Marketing Authorization Application. The approval and CHMP recommendation were based on the positive benefit-risk for HEPLISAV B as demonstrated by the safety and immunogenicity results of three Phase 3 clinical trials. European Commission marketing authorization approval is valid in all EU and EEA-European Free Trade Association (EFTA) states (Norway, Iceland and Liechtenstein). HEPLISAV-B is now approved in the U.S. and EU.お知らせ • Feb 12Dynavax Technologies Corporation to Report Q4, 2020 Results on Feb 25, 2021Dynavax Technologies Corporation announced that they will report Q4, 2020 results After-Market on Feb 25, 2021お知らせ • Feb 09Dong Yu Joins in Dynavax Technologies Corporation as Senior Vice President of Vaccine Research and A Member of the Executive TeamDynavax Technologies Corporation announced that Dong Yu, Ph.D., has joined the Company as Senior Vice President of Vaccine Research and a member of the Executive Team. Dr. Yu will drive Dynavax's vaccine programs and technology platforms, building and maintaining a pipeline for long-term company growth. Dr. Yu joins Dynavax after years at GSK Vaccines, where he held roles of increasing responsibility. Most recently, he was Head of Preclinical R&D U.S., responsible for leading the organization of more than 80 scientists with diverse expertise to drive preclinical R&D of GSK vaccines portfolio in the U.S. Additionally, Dr. Yu was one of twelve founding Vaccines Fellows recognized by GSK for his expertise in vaccines. Prior to GSK, Dr. Yu was at Novartis Vaccines where he led RNA biology and vector development as the Director and Function Head of Microbial Molecular Biology.お知らせ • Feb 05Dynavax Technologies Corporation and Serum Institute of India Announce First Participant Dosed in a Phase 1 Clinical Trial Evaluating an Improved Tdap Vaccine Adjuvanted with CpG 1018Dynavax Technologies Corporation and Serum Institute of India jointly announced that the first participant has been dosed in a Phase 1 clinical trial evaluating a tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine candidate adjuvanted with CpG 1018. Dynavax and SIIPL are collaborating to develop an adjuvanted Tdap vaccine to address the shortcomings of the currently marketed acellular pertussis vaccines. Incidence of pertussis infection in the U.S. and other industrialized countries has been rising since the switch from whole cell pertussis to acellular pertussis vaccines in the 1990s. Although currently marketed acellular pertussis vaccines are effective at providing initial protection from disease, rates of pertussis continue to rise due to waning immunity over time. These vaccines may not prevent the pertussis bacteria from colonizing in the patient, potentially allowing previously vaccinated, asymptomatic individuals to spread the disease. This vaccine candidate has the potential to provide an alternative to the current booster dose given at 10 years of age and older with the goal of increasing the durability of the immune response and reducing transmission from vaccinated individuals who may still spread the disease even if they are asymptomatic. The Phase 1 randomized, open label, active-controlled, dose escalation clinical trial will evaluate the safety, tolerability, and immunogenicity of the vaccine candidate, adjuvanted with CpG?1018, in healthy volunteers 10 to 22 years of age. Dynavax anticipates results from the Phase 1 study to be available in the fourth quarter of 2021. Under the collaboration, Dynavax has exclusive world-wide rights to commercialize the vaccine, except that SII has exclusive rights to distribute in India and to fulfill WHO/UNICEF tender contracts. The parties are responsible for clinical development cost in their respective territories.お知らせ • Feb 02Dynavax Technologies Corporation Enters into an Agreement with the Coalition for Epidemic Preparedness InnovationsDynavax Technologies Corporation announced that it has entered into an agreement with the Coalition for Epidemic Preparedness Innovations, relating to the supply of the Company’s novel toll-like receptor 9 agonist adjuvant, CpG 1018™, at CEPI’s direction, to certain third parties who have agreements with CEPI regarding the funding of development and manufacturing initiatives of vaccines for COVID-19. The Agreement provides for the manufacture and initial reservation of a specified quantity of CpG 1018, and an option, exercisable in CEPI’s sole discretion prior to March 15, 2021, for the manufacture and reservation of an additional quantity of CpG 1018. The Initial Reserved Material is expected to be available for release during the second and third quarters of 2021. The Additional Reserved Material is expected to be available for release during the fourth quarter of 2021. The Agreement also provides CEPI with a first right to reserve additional supply of CpG 1018 to be deliverable in the fourth quarter of 2021, subject to the Company confirming that it has capacity to supply such additional amount. The Agreement enables CEPI, subject to certain limitations and requirements, to direct the supply of Reserved Material to CEPI Partners. CEPI Partners would then purchase CpG 1018 directly from the Company under separately negotiated agreements, subject in certain circumstances to specified pricing requirements. The Agreement also allows the Company to sell the Reserved Material to third-parties if not purchased by a CEPI Partner within a defined period of time. In exchange for the Company reserving CpG 1018 pursuant to the Agreement, CEPI has agreed to provide the Company with an interest-free, unsecured, forgivable loan in an amount equivalent to the anticipated manufacturing costs of all material reserved by CEPI under the Agreement, which, for the Initial Reserved Material and Additional Reserved Material, is up to $99 million (the “ Loan Amount”). Loan Amounts for the Initial Reserved Material will be funded in part upon the execution of the Agreement, in part upon the exercise of CEPI’s option to reserve the Additional Reserved Material, and in part upon the release of the applicable Reserved Material. The Company is obligated to repay the Loan Amount, on a proportional basis, if and to the extent the Company receives payment for the applicable CpG 1018 reserved under the Agreement. If the vaccine programs pursued by CEPI Partners are unsuccessful and no alternative use is found for the adjuvant funded through the Agreement, the applicable Loan Amount will be forgiven. The Agreement will terminate at the earlier of (a) such time as all Reserved Material has been sold and all portions of the Loan Amount have been repaid to CEPI and (b) the second anniversary of the date of the Agreement; provided, however, that the Company will remain obligated to repay any outstanding applicable Loan Amount to the extent that it subsequently receives payment for any Reserved Material that remains unsold as of such second anniversary.お知らせ • Feb 01Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine CandidateClover Biopharmaceuticals and Dynavax Technologies Corporation announced the plan to initiate a global Phase 2/3 efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover's COVID-19 vaccine candidate and will fund the development, including the Phase 2/3 trial, through licensure. In its Phase 1 clinical trial, Clover's protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc (GSK, London Stock Exchange: GSK) both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles. Clover expects to produce hundreds of millions of vaccine doses in 2021 and up to 1 billion vaccine doses in peak annual production as required by global demand.お知らせ • Jan 26Medigen Vaccine Biologics Corporation Vaccine Biologics COVID-19 Vaccine Adjuvanted with Dynavax's CpG 1018 Announces First Participant Dosed in Phase 2 Clinical Trial in TaiwanMedigen Vaccine Biologics Corporation and Dynavax Technologies Corporation announced that the first participant has been dosed in the Phase 2 clinical trial evaluating MVC's COVID-19 vaccine candidate, MVC-COV1901. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax. MVC's Phase 2 clinical trial is a randomized, double-blinded, multi-center clinical trial, expecting to enroll 3,700 healthy subjects, 20 years of age and above. The trial will evaluate MVC-COV1901 safety and endurance of immunogenicity. The proposed dosing regimen is two doses administered intramuscularly one month apart. Based on MVC's Phase 1 interim data, MVC-COV1901 has demonstrated a good safety profile and encouraging immunogenicity performance. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax plus aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by U.S.NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). Â Building upon the S-2P platform, MVC conducted large-scale screenings of various adjuvants and finalized the compositions of MVC-COV1901 vaccine to optimize safety and desired immunogenicity properties. MVC established the production platform of MVC-COV1901 and based on MVC's preclinical and phase 1 clinical study data, MVC-COV1901 showed robust safety and promising immunogenicity responses and as a result entered Phase 2 clinical trial in 2020.株主還元DYF1DE BiotechsDE 市場7D1.3%1.9%2.0%1Y3.6%-11.3%-0.1%株主還元を見る業界別リターン: DYF1過去 1 年間で-11.3 % の収益を上げたGerman Biotechs業界を上回りました。リターン対市場: DYF1は、過去 1 年間で-0.1 % のリターンを上げたGerman市場を下回りました。価格変動Is DYF1's price volatile compared to industry and market?DYF1 volatilityDYF1 Average Weekly Movement14.3%Biotechs Industry Average Movement8.9%Market Average Movement6.2%10% most volatile stocks in DE Market13.3%10% least volatile stocks in DE Market2.7%安定した株価: DYF1の株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: DYF1の 週次ボラティリティ は、過去 1 年間で9%から14%に増加しました。会社概要設立従業員CEO（最高経営責任者ウェブサイト1996405Ryan Spencerwww.dynavax.comダイナバックス・テクノロジーズ・コーポレーションは、コマーシャルステージのバイオ医薬品企業で、米国および国際的なワクチンの開発・商業化に注力している。同社は、18歳以上の成人におけるB型肝炎ウイルスのすべての既知のサブタイプによる感染を予防するB型肝炎ワクチンHEPLISAV-Bと、HEPLISAV-Bに使用されるアジュバントであるCpG 1018を提供している。また、第2相臨床試験中のペストワクチン候補であるrF1V、50歳以上の成人における帯状疱疹の予防を目的とした第1/2相臨床試験中の治験用ワクチン候補であるZ-1018、および血液透析を受けている成人向けのHEPLISAV-Bも開発している。同社は、卸売業者や専門販売業者を通じて、病院や診療所、総合医療ネットワーク、公衆衛生クリニックや刑務所、国防総省、退役軍人省、小売薬局などに製品を販売している。米国国防総省、Coalition for Epidemic Preparedness Innovations、Zhejiang Clover Biopharmaceuticals, Inc.旧社名はダブルヘリックス・コーポレーションで、1996年9月にダイナバックス・テクノロジーズ・コーポレーションに社名変更。ダイナバックス・テクノロジーズ・コーポレーションは1996年に法人化され、カリフォルニア州エメリービルに本社を置いている。もっと見るDynavax Technologies Corporation 基礎のまとめDynavax Technologies の収益と売上を時価総額と比較するとどうか。DYF1 基礎統計学時価総額€1.48b収益（TTM）-€36.49m売上高(TTM)€277.86m5.3xP/Sレシオ-40.6xPER（株価収益率DYF1 は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計DYF1 損益計算書（TTM）収益US$330.51m売上原価US$126.91m売上総利益US$203.60mその他の費用US$247.00m収益-US$43.40m直近の収益報告Sep 30, 2025次回決算日該当なし一株当たり利益（EPS）-0.38グロス・マージン61.60%純利益率-13.13%有利子負債／自己資本比率48.9%DYF1 の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/02/09 21:55終値2026/02/09 00:00収益2025/09/30年間収益2024/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Dynavax Technologies Corporation 3 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。10 アナリスト機関Elemer PirosCantor Fitzgerald & Co.Douglas BuchananCitizens JMP Securities, LLCJason ButlerCitizens JMP Securities, LLC7 その他のアナリストを表示
お知らせ • Feb 11Dynavax Technologies Corporation(NasdaqGS:DVAX) dropped from NASDAQ Composite IndexDynavax Technologies Corporation removed
お知らせ • Feb 10+ 1 more updateSanofi (ENXTPA:SAN) completed the acquisition of Dynavax Technologies Corporation (NasdaqGS:DVAX).Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 23, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources. In case of termination Dynavax will pay $77.85 million and Sanofi will pay $116.77 million. As of January 12, 2025. the Offer will expire at one minute following 11:59 P.M., Eastern Time, on February 9, 2026, unless the Offer is extended by the Sanofi or earlier terminated. The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations, board of directors and shareholders approval. The deal has been unanimously approved by the board. The waiting period under the HSR Act expired, effective January 27, 2026. The acquisition is expected to close in the first quarter of 2026. Goldman Sachs & Co. LLC acted as a financial advisor and fairness opinion provider to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor and fairness opinion provider to Dynavax Technologies. Bill Roegge, Barbara Borden, Steve Przesmicki, Barbara Mirza, Austin Holt, David Burns and Jane Adams of Cooley LLP acted as a legal advisor to Dynavax Technologies. Jannelle Marie Seales, Xander Tabloff, Joseph M. Pari, Olivia J. Greer, John O'Loughlin, Antonia I. Tzinova, Shawn B. Cooley, John E. Scribner, Barbra J. Broudy, Kane Wishart, Paul J. Wessel, Christina A. De Vuono, Sachin Kohli and Michael J. Aiello of Weil, Gotshal & Manges LLP acted as legal advisor to Sanofi. Innisfree M&A Incorporated acted as information agent of Sanofi. Sanofi (ENXTPA:SAN) completed the acquisition of Dynavax Technologies Corporation (NasdaqGS:DVAX) on February 9, 2026. As of the Expiration Time, a total of 84,680,752 Shares had been validly tendered, representing approximately 73.92% of the aggregate number of shares outstanding. In connection with the merger, all Dynavax shares not validly tendered in the tender offer have been converted into the right to receive the same $15.5 per share in cash, without interest, subject to any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of February 10, 2026, Dynavax common stock will cease to be traded on the NASDAQ Global Select Stock Market. The minimum condition and all the other conditions to the offer have been satisfied, and on February 10, 2026, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.
Board Change • Dec 30High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Director Lauren Silvernail was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Dec 24Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion.Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 24, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources. The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations. The deal has been unanimously approved by the board. The acquisition is expected to close in the first quarter of 2026. Goldman Sachs & Co. LLC acted as a financial advisor to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor to Dynavax Technologies. Cooley LLP acted as a legal advisor to Dynavax Technologies.
お知らせ • Nov 07Dynavax Technologies Corporation Reiterates Earnings Guidance for the Year 2025Dynavax Technologies Corporation reiterated earnings guidance for the year 2025. For the year, the company expects for HEPLISAV-B net product revenue to be in the range of $315 million to $325 million.
お知らせ • Nov 06Dynavax Technologies Corporation (NasdaqGS:DVAX) announces an Equity Buyback for $100 million worth of its shares.Dynavax Technologies Corporation (NasdaqGS:DVAX) announced a share repurchase program. Under the program, the company will repurchase up to $100 million of its common stock. The program will reduce the company's cash reserves. The program does not have an expiration date, and company currently expects that purchases will be executed within a period of up to one year.
お知らせ • Feb 11Dynavax Technologies Corporation(NasdaqGS:DVAX) dropped from NASDAQ Composite IndexDynavax Technologies Corporation removed
お知らせ • Feb 10+ 1 more updateSanofi (ENXTPA:SAN) completed the acquisition of Dynavax Technologies Corporation (NasdaqGS:DVAX).Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 23, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources. In case of termination Dynavax will pay $77.85 million and Sanofi will pay $116.77 million. As of January 12, 2025. the Offer will expire at one minute following 11:59 P.M., Eastern Time, on February 9, 2026, unless the Offer is extended by the Sanofi or earlier terminated. The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations, board of directors and shareholders approval. The deal has been unanimously approved by the board. The waiting period under the HSR Act expired, effective January 27, 2026. The acquisition is expected to close in the first quarter of 2026. Goldman Sachs & Co. LLC acted as a financial advisor and fairness opinion provider to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor and fairness opinion provider to Dynavax Technologies. Bill Roegge, Barbara Borden, Steve Przesmicki, Barbara Mirza, Austin Holt, David Burns and Jane Adams of Cooley LLP acted as a legal advisor to Dynavax Technologies. Jannelle Marie Seales, Xander Tabloff, Joseph M. Pari, Olivia J. Greer, John O'Loughlin, Antonia I. Tzinova, Shawn B. Cooley, John E. Scribner, Barbra J. Broudy, Kane Wishart, Paul J. Wessel, Christina A. De Vuono, Sachin Kohli and Michael J. Aiello of Weil, Gotshal & Manges LLP acted as legal advisor to Sanofi. Innisfree M&A Incorporated acted as information agent of Sanofi. Sanofi (ENXTPA:SAN) completed the acquisition of Dynavax Technologies Corporation (NasdaqGS:DVAX) on February 9, 2026. As of the Expiration Time, a total of 84,680,752 Shares had been validly tendered, representing approximately 73.92% of the aggregate number of shares outstanding. In connection with the merger, all Dynavax shares not validly tendered in the tender offer have been converted into the right to receive the same $15.5 per share in cash, without interest, subject to any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of February 10, 2026, Dynavax common stock will cease to be traded on the NASDAQ Global Select Stock Market. The minimum condition and all the other conditions to the offer have been satisfied, and on February 10, 2026, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.
Board Change • Dec 30High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Director Lauren Silvernail was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Dec 24Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion.Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 24, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources. The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations. The deal has been unanimously approved by the board. The acquisition is expected to close in the first quarter of 2026. Goldman Sachs & Co. LLC acted as a financial advisor to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor to Dynavax Technologies. Cooley LLP acted as a legal advisor to Dynavax Technologies.
お知らせ • Nov 07Dynavax Technologies Corporation Reiterates Earnings Guidance for the Year 2025Dynavax Technologies Corporation reiterated earnings guidance for the year 2025. For the year, the company expects for HEPLISAV-B net product revenue to be in the range of $315 million to $325 million.
お知らせ • Nov 06Dynavax Technologies Corporation (NasdaqGS:DVAX) announces an Equity Buyback for $100 million worth of its shares.Dynavax Technologies Corporation (NasdaqGS:DVAX) announced a share repurchase program. Under the program, the company will repurchase up to $100 million of its common stock. The program will reduce the company's cash reserves. The program does not have an expiration date, and company currently expects that purchases will be executed within a period of up to one year.
お知らせ • Oct 23Dynavax Technologies Corporation to Report Q3, 2025 Results on Nov 05, 2025Dynavax Technologies Corporation announced that they will report Q3, 2025 results After-Market on Nov 05, 2025
お知らせ • Oct 22Dynavax Technologies Corporation Presents Positive Topline Data from Part 1 of Phase 1/2 Trial for Shingles Vaccine Candidate at IDWeek 2025 and Announces Initiation of Part 2 of TrialDynavax Technologies Corporation presented positive topline data from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, in a late-breaker session at IDWeek 2025. Dynavax also announced it has initiated Part 2 of the trial evaluating Z-1018 head-to-head versus Shingrix®? in older adults. Key highlights of the data presentation included: Z-1018 adjuvanted with CpG 1018 (with or without alum) showed favorable tolerability and strong humoral and cellular responses across a range of Dynavax-produced gE dosage levels and dosing intervals; Z-1018 groups elicited high anti-gE IgG concentrations, robust CD4+ T-cell frequencies, and VRRs (per IgG and CD4+ criteria) comparable to Shingrix, at 4 weeks after dose 2; In new data presented at IDWeek, Z-1018 induced a high proportion of polyfunctional CD4+ T-cell responses exhibiting multiple gE-specific activation markers, supporting the quality and breadth of the cellular immune response; Formulation consisting of 100 mcg gE adjuvanted with Cp G 1018 plus alum, administered at 0 and 8 weeks, was selected for advancement to Part 2 of the Phase 1/2 trial in which adults aged 70 years and older are being enrolled. Part 2 Study Initiated: Dynavax also announced that the first participants have been dosed in Part 2 of the Phase 1-2 clinical trial. Part 2 of the Phase 1 1/2 trial is a randomized, active-controlled, multicenter study expected to enroll approximately 324 healthy adults aged 70 years and older at trial sites in Australia and New Zealand. The study is designed to further characterize immunogenicity, safety, and tolerability at the selected Z-1018 dose and regimen, including demonstrating non-inferiority to Shingrix on select immunogenicity measures. Dynavax anticipates reporting topline Part 2 immunogenicity and safety data in the second half of 2026.
お知らせ • Oct 16Dynavax Technologies Corporation Announces Executive ChangesIn connection with an internal realignment of various management roles and responsibilities, on October 15, 2025, the Board of Directors (Board) of Dynavax Technologies Corporation (Company) approved the transition of David F. Novack from his roles as the company’s President and Chief Operating Officer to his new roles as Senior Vice President and Chief Operating Officer, effective January 1, 2026. The Board also approved the removal of Robert Janssen, M.D.’s roles as Chief Medical Officer and Senior Vice President, Clinical Development, Medical and Regulatory Affairs, effective upon the earlier to occur of (a) the date the Company employs a new Chief Medical Officer and (b) March 2, 2026, and further approved the conclusion of Dr. Janssen’s employment as of March 2, 2026. The Company has commenced a search process for a successor Chief Medical Officer.
お知らせ • Aug 21Dynavax Technologies Corporation Announces Positive Topline Phase 1/2 Results Supporting Potential Best-In-Class Shingles Vaccine ProfileDynavax Technologies Corporation announced positive topline results from Part 1 of its randomized, observer-blinded, and active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, head-to-head versus Shingrix in participants aged 50 to 69 years. Based on these results, Dynavax intends to advance Z-1018 into Part 2 of the Phase 1/2 program in adults 70 years of age and older, expected to initiate in the second half of 2025. In Part 1 of the trial at one month after the second vaccine dose, Z-1018 demonstrated antibody and CD4+ T cell vaccine responses similar to those observed in the comparator arm receiving Shingrix, the currently licensed shingles vaccine, with a favorable tolerability profile. At the dose formulation and regimen chosen for advancement to Part 2 of the trial, 12.5% of participants receiving Z-1018 reported grade 2 or 3 local PIRs and 27.5% reported grade 2 or 3 systemic PIRs, versus 52.6% and 63.2% for Shingrix, respectively. No safety concerns have been identified in this ongoingblinded study that has oversight by a safety monitoring committee.
お知らせ • Jul 30Dynavax Technologies Corporation to Report Q2, 2025 Results on Aug 07, 2025Dynavax Technologies Corporation announced that they will report Q2, 2025 results After-Market on Aug 07, 2025
お知らせ • Jun 30+ 5 more updatesDynavax Technologies Corporation(NasdaqGS:DVAX) dropped from Russell 2500 Value IndexDynavax Technologies Corporation(NasdaqGS:DVAX) dropped from Russell 2500 Value Index
お知らせ • Jun 10Deep Track Capital Sends Letter to Shareholders of Dynavax TechnologiesOn June 9, 2025, Deep Track Capital, LP issued a letter to shareholders detailing the benefits of electing Dynavax Technologies Corporation’s 4 nominees – Brett Erkman, Jeffrey Farrow, Michael Mullette, and Donald Santel – to the Board of Directors at the upcoming 2025 annual meeting of shareholders on June 11, 2025. Deep Track’s nominees are prepared to collectively enter the boardroom with open-minded perspectives, constructive approach and sole focus on creating value for all shareholders. Deep Track Capital expressed its views that without meaningful Board change ‘valid and critical questions regarding the Company’s strategic direction, capital allocation, and Board responsiveness’ will remain unanswered. Deep Track Capital details urgent need to address Company’s consistent failure to achieve stated targets and reverse heplisav market share stagnation.
お知らせ • May 20Deep Track Capital Posts Investor Presentation to its Campaign WebsiteOn May 19, 2025, Deep Track Capital, LP posted supplemental investor presentation to its campaign website at www.RefocusDVAX.com related to Dynavax Technologies Corporation.
お知らせ • May 16Deep Track Capital Issues Letter to Fellow Shareholders of Dynavax TechnologiesOn May 15, 2025, Deep Track Capital, LP issued a letter to shareholders in connection with its nomination of 4 candidates, Brett Erkman, Jeffrey Farrow, Donald Santel, and Michael Mullette for election to Dynavax Technologies Corporation’s Board of Directors at the 2025 annual meeting of stockholders.
お知らせ • May 13Deep Track Capital Sends Letter to Shareholders of Dynavax Technologies CorporationOn May 12, 2025, Deep Track Capital, LP sent a letter to shareholders of Dynavax Technologies Corporation urging the shareholders to vote for its nominees, Brett Erkman, Jeffrey Farrow, Michael Mullette, and Donald Santel, on the white proxy card at the Company’s annual shareholders meeting.
お知らせ • May 07Dynavax Technologies Corporation Reaffirms Earnings Guidance for the Full Year 2025Dynavax Technologies Corporation reaffirmed earnings guidance for the full year 2025. For the full year 2025, the company expects HEPLISAV-B net product revenue is expected in the range of $305 to $325 million.
お知らせ • Apr 23Dynavax Technologies Corporation to Report Q1, 2025 Results on May 06, 2025Dynavax Technologies Corporation announced that they will report Q1, 2025 results After-Market on May 06, 2025
お知らせ • Apr 22Deep Track Capital Files Definitive Proxy Statement and Sends Letter to Fellow ShareholdersOn April 21, 2025, Deep Track Capital, LP announced that it has filed a definitive proxy statement in connection with its nomination of 4 candidates for election to Dynavax Technologies Corporation’s Board of Directors at the 2025 annual meeting of stockholders. Deep Track also sent a letter to shareholders expressing the Company’s misguided acquisition strategy is destroying value and preventing the Company from maximizing the opportunities of heplisav for shareholders and patients.
お知らせ • Apr 18Dynavax Technologies Corporation, Annual General Meeting, Jun 11, 2025Dynavax Technologies Corporation, Annual General Meeting, Jun 11, 2025.
お知らせ • Apr 16Deep Track Capital Comments on Dynavax Technologies’ Rejection of Settlement OfferOn April 16, 2025, Deep Track Capital LP Commented on the Dynavax Technologies Corporation’s disclosure that the Board of Directors has rejected a settlement proposal in connection with its nomination of 4 candidates for election to the Board at the 2025 annual meeting of shareholders. Deep Track Capital proposed a 3-part proposal to the Company, that 1) Deep Track nominees Brett Erkman and Donald Santel would be appointed to the Board, 2) 2 long-tenured incumbent directors would step down; and 3) the Board would rebalance its classes such that there are 3 directors in each, and it is designed to ensure that a shareholder representative would be in the boardroom and to avoid a proxy contest, and the Company ejected this proposed settlement, and merely reiterated a prior proposal that it has now put forth for a third time. Deep Track criticized the Board's unwillingness to compromise, emphasized the need for investor-driven change and representation in the boardroom, and highlighted its commitment to protecting shareholders' interests and ensuring their voices are heard. Further, Deep Track stated that it remains open to discussions around how to resolve this situation in an amicable fashion, it is committed to protecting the best interests of all Company shareholders and ensuring their voices are heard.
お知らせ • Mar 10Deep Track Capital Sends Letter to Dynavax Technologies’ Board of DirectorsOn March 10, 2025, Deep Track Capital LP announced that it has sent a letter to Dynavax Technologies Corporation’s board of directors, stating that investor feedback supporting its course of action and sharing concerns with company’s capital allocation strategy, poor governance, and lack of shareholder perspective in the boardroom, and there is a desire for a shareholder representative on the Board. Deep Track criticizes the Board for obstructing shareholder rights and mischaracterizing its intentions and highlighted the Company’s refusal to reach a constructive resolution and calls on board to stop engaging in Petty defense tactics, Deep Track questions the issuance of expensive convertible notes instead of using cash on hand and mentioned that the recent refinancing decision is seen as unsophisticated and costly. Deep Track emphasizes the need for new directors to drive strategic improvements and stating that its actions are not about taking control but ensuring better governance and shareholder representation.
お知らせ • Mar 07Dynavax Technologies Corporation announced that it expects to receive $39.7 million in fundingDynavax Technologies Corporation entered into subscription agreement for issuance of 2.50% Convertible Senior Notes due 2026 for gross proceeds of $39.7 million on March 5, 2025. The transaction is expected to close on or about March 13, 2025, subject to customary closing conditions. The New Notes will be issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The Company is relying on this exemption from registration based in part on representations made by the investors in the New Notes in the Exchange and Subscription Agreements.
お知らせ • Feb 21Dynavax Technologies Corporation Provides Revenue Guidance for the Full Year 2025Dynavax Technologies Corporation provided revenue guidance for the full year 2025. For the year, the company expects HEPLISAV-B net product revenue is expected in the range of $305 million to $325 million.
お知らせ • Feb 08Dynavax Technologies Corporation Announces Principal Accounting Officer ChangesOn February 3, 2025, Justin Burgess notified Dynavax Technologies Corporation (the “Company”) that he intends to resign from the Company, including his position as the Company’s principal accounting officer, on or about March 3, 2025. The Company intends to appoint Kelly MacDonald, the Company’s Chief Financial Officer and principal financial officer, as the Company’s principal accounting officer, prior to March 3, 2025. There are no arrangements or understandings between Ms. MacDonald and any other persons in connection with Ms. MacDonald’s appointment as a principal accounting officer.
お知らせ • Feb 07Dynavax Technologies Corporation to Report Q4, 2024 Results on Feb 20, 2025Dynavax Technologies Corporation announced that they will report Q4, 2024 results After-Market on Feb 20, 2025
お知らせ • Jan 28Dynavax Technologies Corporation Announces Board ChangesDynavax Technologies Corporation announced the following changes to its Board of Directors as part of its ongoing refreshment program: Emilio Emini, Ph.D. and Lauren Silvernail have been appointed to the Board, effective February 3, 2025. Dr. Emini will serve as a Class III director with an initial term expiring at the Company's 2027 Annual Meeting and Ms. Silvernail will serve as a Class I director with an initial term expiring at the Company's 2025 Annual Meeting. Peggy Phillips, who has served on the Dynavax Board since 2006, will retire from the Board at the 2025 Annual Meeting. Julie Eastland will step down from the Board at the 2025 Annual Meeting given her recent appointment as chief executive officer of another public company. Dr. Emini brings over 40 years of experience as an executive and academic across the biopharmaceutical industry and global public health roles, helping to develop and deliver multiple anti-infectious disease interventions. Prior to his retirement, Dr. Emini served as Chief Executive Officer of the Bill & Melinda Gates Medical Research Institute and as the Director of the Foundation's Tuberculosis and HIV Programs. At the Merck Research Laboratories, from 1983 to 2004, Dr. Emini led the biological research that developed the first highly active antiretroviral therapies for HIV and led multiple vaccine research teams that contributed to many successful developments, including the vaccines for human papillomavirus and rotavirus. Following a two-year leave from the industry at the International AIDS Vaccine Initiative, Dr. Emini joined Wyeth/Pfizer as the Senior Vice President of Vaccine R&D where he led the development of the Prevenar 13® vaccine for prevention of pneumococcal disease. Dr. Emini holds a Bachelor of Science from Manhattan College and a Ph.D. in Microbiology from the Cornell University Graduate School of Medicine. Ms. Silvernail has three decades of experience leading finance and business development functions across the pharmaceutical industry. She most recently served as Chief Financial Officer and Executive Vice President of Corporate Development of Evolus Inc., from 2018 until her retirement in 2022, where she led fundraising, financial and partnership activities including establishing the infrastructure for the U.S. commercial launch of the company's first approved product. Previously, she served as Chief Financial Officer and Chief Business Officer at Revance Therapeutics Inc., where she led the company's initial public offering and subsequent rounds of financing. Prior to that, Ms. Silvernail was Chief Financial Officer and Executive Vice President of Corporate Development at ISTA Pharmaceuticals until its sale to Bausch & Lomb. Prior to that, she held corporate development roles at Allergan and other companies. Ms. Silvernail is currently a director and Audit Committee Chair of Harrow and previously served as a director and Audit Committee Chair at Harpoon Therapeutics until its successful sale to Merck and a director and Corporate Governance Committee chair at Nicox S.A. She earned an M.B.A. in finance and accounting from the Anderson Graduate School of Management at UCLA, and a B.A. in Biophysics from the University of California, Berkeley.
Reported Earnings • Nov 08Third quarter 2024 earnings released: EPS: US$0.13 (vs US$0.11 in 3Q 2023)Third quarter 2024 results: EPS: US$0.13 (up from US$0.11 in 3Q 2023). Revenue: US$80.6m (up 16% from 3Q 2023). Net income: US$17.6m (up 23% from 3Q 2023). Profit margin: 22% (up from 21% in 3Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 33% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings.
お知らせ • Nov 08+ 1 more updateDynavax Technologies Corporation (NasdaqGS:DVAX) announces an Equity Buyback for $200 million worth of its shares.Dynavax Technologies Corporation (NasdaqGS:DVAX) announced a share repurchase program. Under the program, the company will repurchase up to $200 million of its common stock. The program will reduce the company's cash reserves. The program does not have an expiration date, and purchases are expected to be executed within a period of up to one year.
お知らせ • Oct 25Dynavax Technologies Corporation to Report Q3, 2024 Results on Nov 07, 2024Dynavax Technologies Corporation announced that they will report Q3, 2024 results After-Market on Nov 07, 2024
Reported Earnings • Aug 07Second quarter 2024 earnings released: EPS: US$0.087 (vs US$0.027 in 2Q 2023)Second quarter 2024 results: EPS: US$0.087 (up from US$0.027 in 2Q 2023). Revenue: US$73.8m (up 23% from 2Q 2023). Net income: US$11.4m (up 232% from 2Q 2023). Profit margin: 15% (up from 5.7% in 2Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 8% per year whereas the company’s share price has fallen by 3% per year.
お知らせ • Jul 24Dynavax Technologies Corporation to Report Q2, 2024 Results on Aug 06, 2024Dynavax Technologies Corporation announced that they will report Q2, 2024 results After-Market on Aug 06, 2024
お知らせ • Jun 28Dynavax Technologies Corporation Initiates Phase 1/2 Study of Novel Shingles Vaccine ProgramDynavax Technologies Corporation announced that the first participant has been dosed in a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018, the company's investigational vaccine candidate being developed for the prevention of shingles (herpes zoster), a debilitating disease caused by the varicella-zoster virus. The Phase 1/2 randomized, active-controlled, dose escalation, multicenter trial is expected to enroll approximately 440 healthy adults aged 50 to 69 years at trial sites in Australia, and will evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix®. Key objectives of the trial include selecting the optimal glycoprotein E (gE) protein dose level and dosing schedule for further clinical development. The Phase 1/2 trial will be used to support validation of a Patient Reported Outcome measurement tool to differentiate Z-1018 on tolerability and to support potential label claims. Dynavax anticipates reporting top line immunogenicity and safety data in the second half of 2025, including a comparison of CD4+ T-cells one month after the second of two vaccine doses.
お知らせ • May 15Dynavax Technologies Corporation Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.SDynavax Technologies Corporation provided a regulatory update for the company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on Hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of effectiveness or safety of a four-dose regimen of HEPLISAV-B. The CRL has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which is for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CRL also does not affect the approval decision received from the European Commission in October 2023 for the four-dose HEPLIS AV-B regimen for the adult hemodialysis population. The sBLA was comprised of clinical immunogenicity and safety data from the Phase 1 HBV-24 study of a four-dose regimen. The CRL stated that the data from HBV-24 were insufficient due to the destruction of data source documents by a third-party clinical trial site operator for approximately half of the subjects enrolled in the trial. In addition, the total number of subjects in the single-arm HBV-24 study was deemed to be insufficient to evaluate safety of the four-dose regimen. Important U.S. Product Information: HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. Important U.S. Safety Information (ISI): Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast; Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B; Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B; Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration; The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).
お知らせ • May 10Dynavax Technologies Corporation Reaffirms Financial Guidance for the Full Year 2024Dynavax Technologies Corporation reaffirmed financial guidance for the full year 2024. For the year, the company expects HEPLISAV-B net product revenue between approximately $265 million - $280 million, including approximately $3 million in ex-U.S. sales through commercialization partnership in Germany.
Reported Earnings • May 09First quarter 2024 earnings released: US$0.067 loss per share (vs US$0.19 loss in 1Q 2023)First quarter 2024 results: US$0.067 loss per share (improved from US$0.19 loss in 1Q 2023). Revenue: US$50.8m (up 8.2% from 1Q 2023). Net loss: US$8.72m (loss narrowed 64% from 1Q 2023). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 24% per year whereas the company’s share price has increased by 22% per year.
お知らせ • Apr 26Dynavax Technologies Corporation to Report Q1, 2024 Results on May 08, 2024Dynavax Technologies Corporation announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 08, 2024
お知らせ • Apr 12Dynavax Technologies Corporation, Annual General Meeting, May 23, 2024Dynavax Technologies Corporation, Annual General Meeting, May 23, 2024, at 09:00 Pacific Standard Time. Agenda: To consider and elect our three nominees for Class III directors to hold office until the 2027 Annual Meeting of Stockholders or until their respective successors are duly elected and qualified; to consider and approve the amendment and restatement of the Dynavax Technologies Corporation 2018 Equity Incentive Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 11,400,000; to consider and approve, on an advisory basis, the compensation of the Company’s named executive officers, as disclosed in the proxy statement accompanying this Notice; and to transact such other business matters.
New Risk • Feb 24New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.3% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company.
Reported Earnings • Feb 23Full year 2023 earnings released: US$0.05 loss per share (vs US$2.32 profit in FY 2022)Full year 2023 results: US$0.05 loss per share (down from US$2.32 profit in FY 2022). Revenue: US$232.3m (down 68% from FY 2022). Net loss: US$6.39m (down 102% from profit in FY 2022). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 54% per year but the company’s share price has only increased by 13% per year, which means it is significantly lagging earnings growth.
お知らせ • Feb 23Dynavax Technologies Corporation Provides Revenue Guidance for the Year 2024Dynavax Technologies Corporation provided revenue guidance for the year 2024. The company expects HEPLISAV-B net product revenue between approximately $265 million - $280 million, including approximately $3 million in ex-U.S. sales through commercialization agreement with Bavarian Nordic in Germany.
お知らせ • Feb 09Dynavax Technologies Corporation to Report Q4, 2023 Results on Feb 22, 2024Dynavax Technologies Corporation announced that they will report Q4, 2023 results After-Market on Feb 22, 2024
お知らせ • Nov 03Dynavax Technologies Corporation Revises Earnings Guidance for the Full Year 2023Dynavax Technologies Corporation revised earnings guidance for the full year 2023. For the year, the company expects HEPLISAV-B net product revenuebetween approximately $210 million - $220 million, compared to the prior range of approximately $200 million - $215 million.
Reported Earnings • Nov 03Third quarter 2023 earnings released: EPS: US$0.11 (vs US$0.50 in 3Q 2022)Third quarter 2023 results: EPS: US$0.11 (down from US$0.50 in 3Q 2022). Revenue: US$69.5m (down 59% from 3Q 2022). Net income: US$14.3m (down 78% from 3Q 2022). Profit margin: 21% (down from 38% in 3Q 2022). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 83% per year but the company’s share price has only increased by 55% per year, which means it is significantly lagging earnings growth.
お知らせ • Oct 27Dynavax Technologies Corporation to Report Q3, 2023 Results on Nov 02, 2023Dynavax Technologies Corporation announced that they will report Q3, 2023 results After-Market on Nov 02, 2023
Reported Earnings • Aug 04Second quarter 2023 earnings released: EPS: US$0.027 (vs US$1.02 in 2Q 2022)Second quarter 2023 results: EPS: US$0.027 (down from US$1.02 in 2Q 2022). Revenue: US$60.2m (down 77% from 2Q 2022). Net income: US$3.43m (down 97% from 2Q 2022). Profit margin: 5.7% (down from 50% in 2Q 2022). Revenue is forecast to grow 6.7% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 105% per year but the company’s share price has only increased by 22% per year, which means it is significantly lagging earnings growth.
お知らせ • Jul 23Dynavax Technologies Corporation to Report Q2, 2023 Results on Aug 03, 2023Dynavax Technologies Corporation announced that they will report Q2, 2023 results After-Market on Aug 03, 2023
Recent Insider Transactions • May 08President & COO recently sold €174k worth of stockOn the 4th of May, David Novack sold around 18k shares on-market at roughly €9.91 per share. This transaction amounted to 85% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. David has been a net seller over the last 12 months, reducing personal holdings by €819k.
お知らせ • May 04Dynavax Technologies Corporation Reaffirms Revenue Guidance for the Year 2023Dynavax Technologies Corporation reaffirmed revenue guidance for the year 2023. The company is reaffirming HEPLISAV-B net product revenue guidance for full year 2023 of between $165–$185 million, representing annual revenue growth of 30%-47%.
Reported Earnings • May 03First quarter 2023 earnings released: US$0.19 loss per share (vs US$0.26 profit in 1Q 2022)First quarter 2023 results: US$0.19 loss per share (down from US$0.26 profit in 1Q 2022). Revenue: US$46.9m (down 59% from 1Q 2022). Net loss: US$24.3m (down 174% from profit in 1Q 2022). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 118% per year but the company’s share price has only increased by 36% per year, which means it is significantly lagging earnings growth.
Reported Earnings • Feb 24Full year 2022 earnings released: EPS: US$2.32 (vs US$0.62 in FY 2021)Full year 2022 results: EPS: US$2.32 (up from US$0.62 in FY 2021). Revenue: US$722.7m (up 65% from FY 2021). Net income: US$293.2m (up 306% from FY 2021). Profit margin: 41% (up from 17% in FY 2021). The increase in margin was driven by higher revenue. Revenue is expected to decline by 11% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 18%. Over the last 3 years on average, earnings per share has increased by 123% per year but the company’s share price has only increased by 41% per year, which means it is significantly lagging earnings growth.
お知らせ • Feb 10Dynavax Technologies Corporation to Report Q4, 2022 Results on Feb 23, 2023Dynavax Technologies Corporation announced that they will report Q4, 2022 results at 4:00 PM, US Eastern Standard Time on Feb 23, 2023
Recent Insider Transactions • Nov 16President & COO recently sold €646k worth of stockOn the 8th of November, David Novack sold around 52k shares on-market at roughly €12.37 per share. This transaction amounted to 96% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was David's only on-market trade for the last 12 months.
Reported Earnings • Nov 05Third quarter 2022 earnings released: EPS: US$0.50 (vs US$0.24 loss in 3Q 2021)Third quarter 2022 results: EPS: US$0.50 (up from US$0.24 loss in 3Q 2021). Revenue: US$167.7m (up 57% from 3Q 2021). Net income: US$63.8m (up US$92.2m from 3Q 2021). Profit margin: 38% (up from net loss in 3Q 2021). The move to profitability was primarily driven by higher revenue. Revenue is expected to decline by 16% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 21%. Over the last 3 years on average, earnings per share has increased by 119% per year but the company’s share price has only increased by 50% per year, which means it is significantly lagging earnings growth.
お知らせ • Nov 04Dynavax Technologies Corporation Provides Revenue Guidance for the Year 2022Dynavax Technologies Corporation provided revenue guidance for the year 2022. The company anticipates 2022 revenues, operating expenses, and other costs to be in the ranges shown below, consistent with the Company's previous financial guidance provided on August 4, 2022: Full-year CpG 1018 adjuvant net product revenues of between $550 million and $600 million.
お知らせ • Oct 21Dynavax Technologies Corporation to Report Q3, 2022 Results on Nov 03, 2022Dynavax Technologies Corporation announced that they will report Q3, 2022 results After-Market on Nov 03, 2022
お知らせ • Sep 13Dynavax Technologies Corporation Announces First Participant Dosed in A Phase 2 Clinical Trial Evaluating an Adjuvanted Plague VaccineDynavax Technologies Corporation in collaboration with the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and supported by the DOD's Chemical and Biological Defense Program announced that the first participant has been dosed in a Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability of the JPEO-CBRND's Recombinant Plague (rF1V) vaccine combined with Dynavax's CpG 1018®adjuvant, in adults 18 to 55 years of age. As previously announced, Dynavax and the DOD executed an agreement which provides for approximately $22 million in funding over two and a half years to develop an improved recombinant plague vaccine adjuvanted with CpG 1018 adjuvant. Under the agreement, Dynavax will conduct a Phase 2 clinical trial combining its CpG 1018 adjuvant with the DOD's rF1V vaccine. The trial is assessing a two-dose regimen administered over one month. Previous clinical studies of the rF1V, not including CpG 1018 adjuvant, have evaluated a three-dose regimen over six months. Any future commercial supply agreements would be subject to a separate agreement between Dynavax and the U.S government.
Valuation Update With 7 Day Price Move • Aug 25Investor sentiment deteriorated over the past weekAfter last week's 17% share price decline to €11.48, the stock trades at a forward P/E ratio of 13x. Average forward P/E is 22x in the Biotechs industry in Europe. Total returns to shareholders of 333% over the past three years.
Valuation Update With 7 Day Price Move • Aug 11Investor sentiment improved over the past weekAfter last week's 21% share price gain to €16.50, the stock trades at a forward P/E ratio of 20x. Average forward P/E is 25x in the Biotechs industry in Europe. Total returns to shareholders of 522% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €18.23 per share.
Reported Earnings • Aug 05Second quarter 2022 earnings released: EPS: US$1.02 (vs US$0.039 in 2Q 2021)Second quarter 2022 results: EPS: US$1.02 (up from US$0.039 in 2Q 2021). Revenue: US$256.5m (up 386% from 2Q 2021). Net income: US$128.8m (up US$124.3m from 2Q 2021). Profit margin: 50% (up from 8.5% in 2Q 2021). The increase in margin was driven by higher revenue. Over the next year, revenue is expected to shrink by 15% compared to a 31% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 107% per year but the company’s share price has only increased by 72% per year, which means it is significantly lagging earnings growth.
お知らせ • Aug 05Dynavax Technologies Corporation Revises Earnings Guidance for the Year 2022Dynavax Technologies Corporation revised earnings guidance for the year 2022. The Company now expects 2022 full-year CpG 1018 adjuvant COVID-19 supply revenue to be between $550 million and $600 million, based on committed orders, with an anticipated full-year gross margin of approximately 60%.
お知らせ • Jul 22Dynavax Technologies Corporation to Report Q2, 2022 Results on Aug 04, 2022Dynavax Technologies Corporation announced that they will report Q2, 2022 results After-Market on Aug 04, 2022
Valuation Update With 7 Day Price Move • Jul 08Investor sentiment improved over the past weekAfter last week's 21% share price gain to €14.09, the stock trades at a forward P/E ratio of 15x. Average forward P/E is 31x in the Biotechs industry in Europe. Total returns to shareholders of 327% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €19.25 per share.
Valuation Update With 7 Day Price Move • Jun 15Investor sentiment deteriorated over the past weekAfter last week's 18% share price decline to €9.67, the stock trades at a forward P/E ratio of 10x. Average forward P/E is 31x in the Biotechs industry in Europe. Total returns to shareholders of 178% over the past three years.
Valuation Update With 7 Day Price Move • May 18Investor sentiment improved over the past weekAfter last week's 21% share price gain to €9.22, the stock trades at a forward P/E ratio of 12x. Average forward P/E is 33x in the Biotechs industry in Europe. Total returns to shareholders of 60% over the past three years.
お知らせ • May 08Dynavax Technologies Corporation Reaffirms Earnings Guidance for the Year 2022Dynavax Technologies Corporation reaffirmed earnings guidance for the year 2022. For the full-year CpG 1018 adjuvant net product revenues of at least $550 million, with an associated gross margin of approximately 50%.
Reported Earnings • May 07First quarter 2022 earnings released: EPS: US$0.26 (vs US$0.007 in 1Q 2021)First quarter 2022 results: EPS: US$0.26 (up from US$0.007 in 1Q 2021). Revenue: US$114.0m (up 37% from 1Q 2021). Net income: US$32.9m (up US$32.0m from 1Q 2021). Profit margin: 29% (up from 1.0% in 1Q 2021). The increase in margin was primarily driven by higher revenue. Over the next year, revenue is forecast to grow 29%, compared to a 37% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 90% per year but the company’s share price has only increased by 12% per year, which means it is significantly lagging earnings growth.
お知らせ • Apr 22Dynavax Technologies Corporation to Report Q1, 2022 Results on May 05, 2022Dynavax Technologies Corporation announced that they will report Q1, 2022 results After-Market on May 05, 2022
お知らせ • Apr 15Dynavax Technologies Corporation, Annual General Meeting, May 26, 2022Dynavax Technologies Corporation, Annual General Meeting, May 26, 2022, at 09:00 Pacific Standard Time. Agenda: To elect our five nominees for Class I directors to hold office until the 2025 Annual Meeting of Stockholders or until their respective successors are duly elected and qualified; To approve the amendment and restatement of the Dynavax Technologies Corporation 2018 Equity Incentive Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 15,000,000; To approve, on an advisory basis, the compensation of the Company's named executive officers, as disclosed in the proxy statement accompanying this Notice; and to ratify the selection of Ernst & Young LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2022.
Valuation Update With 7 Day Price Move • Mar 09Investor sentiment deteriorated over the past weekAfter last week's 18% share price decline to €8.85, the stock trades at a forward P/E ratio of 8x. Average forward P/E is 38x in the Biotechs industry in Europe. Total returns to shareholders of 14% over the past three years.
Reported Earnings • Mar 02Full year 2021 earnings: EPS in line with expectations, revenues disappointFull year 2021 results: EPS: US$0.70 (up from US$0.75 loss in FY 2020). Revenue: US$439.4m (up US$392.9m from FY 2020). Net income: US$81.3m (up US$156.5m from FY 2020). Profit margin: 19% (up from net loss in FY 2020). The move to profitability was driven by higher revenue. Revenue missed analyst estimates by 2.2%. Over the next year, revenue is forecast to grow 60%, compared to a 64% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 75% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth.
お知らせ • Mar 02Dynavax Technologies Corporation Provides Revenue Guidance for the Full Year 2022Dynavax Technologies Corporation provided revenue guidance for the Full Year 2022. For the year, the company expected CpG 1018 adjuvant net product revenues of at least $550 million, with associated gross margin of approximately 50%.
お知らせ • Feb 17Dynavax Technologies Corporation to Report Q4, 2021 Results on Feb 28, 2022Dynavax Technologies Corporation announced that they will report Q4, 2021 results After-Market on Feb 28, 2022
Breakeven Date Change • Dec 31Forecast breakeven date pushed back to 2022The 4 analysts covering Dynavax Technologies previously expected the company to break even in 2021. New consensus forecast suggests the company will make a profit of US$234.9m in 2022.
Reported Earnings • Nov 06Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.04 profit in 3Q 2020)The company reported a decent third quarter result with improved revenues, although earnings and control over costs were weaker. Third quarter 2021 results: Revenue: US$108.3m (up US$94.9m from 3Q 2020). Net loss: US$28.4m (down US$32.8m from profit in 3Q 2020). Over the last 3 years on average, earnings per share has increased by 57% per year but the company’s share price has only increased by 7% per year, which means it is significantly lagging earnings growth.
Breakeven Date Change • Sep 23Forecast to breakeven in 2021The 5 analysts covering Dynavax Technologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$54.2m in 2021.
お知らせ • Aug 25Medigen Vaccine Biologics Corporation and Dynavax Technologies Corporation Announces Launch of Its Covid-19 Vaccine Mvc-Cov1901 Adjuvanted with Dynavax's Cpg 1018 AdjuvantMedigen Vaccine Biologics Corporation, and Dynavax Technologies Corporation announced the rollout of its COVID-19 vaccine, MVC-COV1901. Approximately 600,000 people are anticipated to receive the Medigen vaccine this week. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax and aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by the U.S.NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). MVC-COV1901 vaccine's Phase 1 and 3,815-participant Phase 2 clinical study data has shown robust safety and promising immunogenicity responses and as a result obtained Taiwan's EUA approval on July 19th, 2021. MVC will continue to collaborate with international partners for phase 3 clinical trial development and assist the global community in its fight against the COVID-19 pandemic.
Reported Earnings • Aug 06Second quarter 2021 earnings released: EPS US$0.039 (vs US$0.53 loss in 2Q 2020)The company reported a strong second quarter result with improved earnings, revenues and profit margins. Second quarter 2021 results: Revenue: US$52.8m (up US$50.1m from 2Q 2020). Net income: US$4.47m (up US$56.1m from 2Q 2020). Profit margin: 8.5% (up from net loss in 2Q 2020). Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings.
Board Change • Jul 31High number of new directorsIndependent Director Julie Eastland was the last director to join the board, commencing their role in 2020.
お知らせ • Jun 28+ 2 more updatesDynavax Technologies Corporation(NasdaqCM:DVAX) dropped from Russell 3000E Value IndexDynavax Technologies Corporation(NasdaqCM:DVAX) dropped from Russell 3000E Value Index
Reported Earnings • May 08First quarter 2021 earnings released: EPS US$0.008 (vs US$0.15 loss in 1Q 2020)The company reported a strong first quarter result with improved earnings, revenues and profit margins. First quarter 2021 results: Revenue: US$83.3m (up US$72.4m from 1Q 2020). Net income: US$891.0k (up US$13.5m from 1Q 2020). Profit margin: 1.1% (up from net loss in 1Q 2020). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 30% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings.
Reported Earnings • Feb 27Full year 2020 earnings released: US$0.75 loss per share (vs US$2.16 loss in FY 2019)The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: US$46.6m (up 32% from FY 2019). Net loss: US$75.2m (loss narrowed 52% from FY 2019). Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings.
Analyst Estimate Surprise Post Earnings • Feb 27Revenue beats expectationsRevenue exceeded analyst estimates by 16%. Over the next year, revenue is forecast to grow 409%, compared to a 52% growth forecast for the Biotechs industry in Germany.
お知らせ • Feb 20Dynavax Technologies Corporation Announces European Commission Marketing Authorization for HEPLISAV B®, a 2 Dose Adult Hepatitis B Adjuvanted VaccineDynavax Technologies Corporation announced that the European Commission (EC) has granted Marketing Authorization for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The approval was issued following the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion on the company's Marketing Authorization Application. The approval and CHMP recommendation were based on the positive benefit-risk for HEPLISAV B as demonstrated by the safety and immunogenicity results of three Phase 3 clinical trials. European Commission marketing authorization approval is valid in all EU and EEA-European Free Trade Association (EFTA) states (Norway, Iceland and Liechtenstein). HEPLISAV-B is now approved in the U.S. and EU.
お知らせ • Feb 12Dynavax Technologies Corporation to Report Q4, 2020 Results on Feb 25, 2021Dynavax Technologies Corporation announced that they will report Q4, 2020 results After-Market on Feb 25, 2021
お知らせ • Feb 09Dong Yu Joins in Dynavax Technologies Corporation as Senior Vice President of Vaccine Research and A Member of the Executive TeamDynavax Technologies Corporation announced that Dong Yu, Ph.D., has joined the Company as Senior Vice President of Vaccine Research and a member of the Executive Team. Dr. Yu will drive Dynavax's vaccine programs and technology platforms, building and maintaining a pipeline for long-term company growth. Dr. Yu joins Dynavax after years at GSK Vaccines, where he held roles of increasing responsibility. Most recently, he was Head of Preclinical R&D U.S., responsible for leading the organization of more than 80 scientists with diverse expertise to drive preclinical R&D of GSK vaccines portfolio in the U.S. Additionally, Dr. Yu was one of twelve founding Vaccines Fellows recognized by GSK for his expertise in vaccines. Prior to GSK, Dr. Yu was at Novartis Vaccines where he led RNA biology and vector development as the Director and Function Head of Microbial Molecular Biology.
お知らせ • Feb 05Dynavax Technologies Corporation and Serum Institute of India Announce First Participant Dosed in a Phase 1 Clinical Trial Evaluating an Improved Tdap Vaccine Adjuvanted with CpG 1018Dynavax Technologies Corporation and Serum Institute of India jointly announced that the first participant has been dosed in a Phase 1 clinical trial evaluating a tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine candidate adjuvanted with CpG 1018. Dynavax and SIIPL are collaborating to develop an adjuvanted Tdap vaccine to address the shortcomings of the currently marketed acellular pertussis vaccines. Incidence of pertussis infection in the U.S. and other industrialized countries has been rising since the switch from whole cell pertussis to acellular pertussis vaccines in the 1990s. Although currently marketed acellular pertussis vaccines are effective at providing initial protection from disease, rates of pertussis continue to rise due to waning immunity over time. These vaccines may not prevent the pertussis bacteria from colonizing in the patient, potentially allowing previously vaccinated, asymptomatic individuals to spread the disease. This vaccine candidate has the potential to provide an alternative to the current booster dose given at 10 years of age and older with the goal of increasing the durability of the immune response and reducing transmission from vaccinated individuals who may still spread the disease even if they are asymptomatic. The Phase 1 randomized, open label, active-controlled, dose escalation clinical trial will evaluate the safety, tolerability, and immunogenicity of the vaccine candidate, adjuvanted with CpG?1018, in healthy volunteers 10 to 22 years of age. Dynavax anticipates results from the Phase 1 study to be available in the fourth quarter of 2021. Under the collaboration, Dynavax has exclusive world-wide rights to commercialize the vaccine, except that SII has exclusive rights to distribute in India and to fulfill WHO/UNICEF tender contracts. The parties are responsible for clinical development cost in their respective territories.
お知らせ • Feb 02Dynavax Technologies Corporation Enters into an Agreement with the Coalition for Epidemic Preparedness InnovationsDynavax Technologies Corporation announced that it has entered into an agreement with the Coalition for Epidemic Preparedness Innovations, relating to the supply of the Company’s novel toll-like receptor 9 agonist adjuvant, CpG 1018™, at CEPI’s direction, to certain third parties who have agreements with CEPI regarding the funding of development and manufacturing initiatives of vaccines for COVID-19. The Agreement provides for the manufacture and initial reservation of a specified quantity of CpG 1018, and an option, exercisable in CEPI’s sole discretion prior to March 15, 2021, for the manufacture and reservation of an additional quantity of CpG 1018. The Initial Reserved Material is expected to be available for release during the second and third quarters of 2021. The Additional Reserved Material is expected to be available for release during the fourth quarter of 2021. The Agreement also provides CEPI with a first right to reserve additional supply of CpG 1018 to be deliverable in the fourth quarter of 2021, subject to the Company confirming that it has capacity to supply such additional amount. The Agreement enables CEPI, subject to certain limitations and requirements, to direct the supply of Reserved Material to CEPI Partners. CEPI Partners would then purchase CpG 1018 directly from the Company under separately negotiated agreements, subject in certain circumstances to specified pricing requirements. The Agreement also allows the Company to sell the Reserved Material to third-parties if not purchased by a CEPI Partner within a defined period of time. In exchange for the Company reserving CpG 1018 pursuant to the Agreement, CEPI has agreed to provide the Company with an interest-free, unsecured, forgivable loan in an amount equivalent to the anticipated manufacturing costs of all material reserved by CEPI under the Agreement, which, for the Initial Reserved Material and Additional Reserved Material, is up to $99 million (the “ Loan Amount”). Loan Amounts for the Initial Reserved Material will be funded in part upon the execution of the Agreement, in part upon the exercise of CEPI’s option to reserve the Additional Reserved Material, and in part upon the release of the applicable Reserved Material. The Company is obligated to repay the Loan Amount, on a proportional basis, if and to the extent the Company receives payment for the applicable CpG 1018 reserved under the Agreement. If the vaccine programs pursued by CEPI Partners are unsuccessful and no alternative use is found for the adjuvant funded through the Agreement, the applicable Loan Amount will be forgiven. The Agreement will terminate at the earlier of (a) such time as all Reserved Material has been sold and all portions of the Loan Amount have been repaid to CEPI and (b) the second anniversary of the date of the Agreement; provided, however, that the Company will remain obligated to repay any outstanding applicable Loan Amount to the extent that it subsequently receives payment for any Reserved Material that remains unsold as of such second anniversary.
お知らせ • Feb 01Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine CandidateClover Biopharmaceuticals and Dynavax Technologies Corporation announced the plan to initiate a global Phase 2/3 efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover's COVID-19 vaccine candidate and will fund the development, including the Phase 2/3 trial, through licensure. In its Phase 1 clinical trial, Clover's protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc (GSK, London Stock Exchange: GSK) both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles. Clover expects to produce hundreds of millions of vaccine doses in 2021 and up to 1 billion vaccine doses in peak annual production as required by global demand.
お知らせ • Jan 26Medigen Vaccine Biologics Corporation Vaccine Biologics COVID-19 Vaccine Adjuvanted with Dynavax's CpG 1018 Announces First Participant Dosed in Phase 2 Clinical Trial in TaiwanMedigen Vaccine Biologics Corporation and Dynavax Technologies Corporation announced that the first participant has been dosed in the Phase 2 clinical trial evaluating MVC's COVID-19 vaccine candidate, MVC-COV1901. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax. MVC's Phase 2 clinical trial is a randomized, double-blinded, multi-center clinical trial, expecting to enroll 3,700 healthy subjects, 20 years of age and above. The trial will evaluate MVC-COV1901 safety and endurance of immunogenicity. The proposed dosing regimen is two doses administered intramuscularly one month apart. Based on MVC's Phase 1 interim data, MVC-COV1901 has demonstrated a good safety profile and encouraging immunogenicity performance. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax plus aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by U.S.NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). Â Building upon the S-2P platform, MVC conducted large-scale screenings of various adjuvants and finalized the compositions of MVC-COV1901 vaccine to optimize safety and desired immunogenicity properties. MVC established the production platform of MVC-COV1901 and based on MVC's preclinical and phase 1 clinical study data, MVC-COV1901 showed robust safety and promising immunogenicity responses and as a result entered Phase 2 clinical trial in 2020.
