This company listing is no longer activeThis company may still be operating, however this listing is no longer active.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 EventsDURECT（DC8A）株式概要バイオ医薬品会社であるDURECT Corporationは、エピジェネティック・レギュレーター・プログラムに基づいて医薬品を開発している。 詳細DC8A ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性3/6配当金0/6報酬過去5年間の収益は年間0.9%増加しました。 リスク分析キャッシュランウェイが1年未満である 今後3年間の収益は年平均59.6%減少すると予測されている。 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意味のある時価総額がありません ( €51M )+2 さらなるリスクすべてのリスクチェックを見るDC8A 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€1.609.3k% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-39m43m2016201920222025202620282031Revenue US$252.2kEarnings US$36.8kAdvancedSet Fair ValueView all narrativesDURECT Corporation 競合他社Cantourage GroupSymbol: XTRA:HIGHMarket cap: €75.1mApontis PharmaSymbol: XTRA:APPHMarket cap: €91.6mBiofronteraSymbol: XTRA:B8FKMarket cap: €14.7mAcuCortSymbol: BST:NV5Market cap: €201.9m価格と性能株価の高値、安値、推移の概要DURECT過去の株価現在の株価US$1.6052週高値US$1.6652週安値US$0.39ベータ0.931ヶ月の変化1.91%3ヶ月変化238.98%1年変化16.79%3年間の変化-76.30%5年間の変化-89.12%IPOからの変化-99.00%最新ニュースお知らせ • Sep 22DURECT Corporation Files Form 15DURECT Corporation has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.0001 per share.お知らせ • Sep 13DURECT Corporation(NasdaqCM:DRRX) dropped from NASDAQ Composite IndexDURECT Corporation has been dropped from the NASDAQ Composite Indexお知らせ • Sep 11+ 1 more updateBausch Health Companies Inc. (NYSE:BHC) completed the acquisition of DURECT Corporation (NasdaqCM:DRRX).Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. As of August 26, 2025, DURECT Corporation announced the extension of the expiration date of its tender offer. The Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on September 9, 2025, has been extended until 5:00 p.m., New York City time, on September 10, 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation. Equiniti Trust Company, LLC acted as depositary bank to Bausch. Bausch Health Companies Inc. (NYSE:BHC) completed the acquisition of DURECT Corporation (NasdaqCM:DRRX) on September 11, 2025.お知らせ • Jul 29Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million.Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation.お知らせ • Jul 13DURECT Receives Additional 180-Day Grace Period from Nasdaq to Regain Compliance with the Minimum Bid Price RequirementAs previously reported on a Current Report on Form 8-K filed with the Securities and Exchange Commission (the ‘SEC’) on January 10, 2025, DURECT Corporation (the ‘Company’) received a letter (the ‘Notice’) from The Nasdaq Stock Market (‘Nasdaq’), dated January 9, 2025, advising the Company that for 30 consecutive trading days preceding the date of the Notice, the bid price of the Company’s common stock had closed below the $1.00 per share minimum required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). The Notice stated that the Company had 180 days, or until July 8, 2025, to demonstrate its compliance with the Minimum Bid Price Requirement. On July 9, 2025, the Company received approval from the Listing Qualifications Department of Nasdaq for an additional 180-day grace period, or until January 5, 2026, to regain compliance with the Minimum Bid Price Requirement (the ‘Approval’). To regain compliance with the Minimum Bid Price Requirement and qualify for continued listing on The Nasdaq Capital Market, the minimum bid price per share of the Company’s common stock must be at least $1.00 for at least ten consecutive business days during the additional 180-day grace period. If the Company does not regain compliance during this additional grace period, its common stock would be subject to delisting by Nasdaq. As part of its request for an additional 180-day grace period, the Company notified Nasdaq that (i) the Company meets the continued listing standard for market value of publicly-held shares and all other applicable requirements for initial listing standards of The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) if the Company’s stock price does not recover sufficiently during the additional grace period, it anticipates implementing and completing a reverse stock split by no later than December 16, 2025, if necessary. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock during the additional grace period, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the additional grace period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day additional grace period or maintain compliance with the other Nasdaq listing requirements.お知らせ • Mar 20DURECT Corporation to Report Q4, 2024 Results on Mar 26, 2025DURECT Corporation announced that they will report Q4, 2024 results at 4:00 PM, US Eastern Standard Time on Mar 26, 2025最新情報をもっと見るRecent updatesお知らせ • Sep 22DURECT Corporation Files Form 15DURECT Corporation has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.0001 per share.お知らせ • Sep 13DURECT Corporation(NasdaqCM:DRRX) dropped from NASDAQ Composite IndexDURECT Corporation has been dropped from the NASDAQ Composite Indexお知らせ • Sep 11+ 1 more updateBausch Health Companies Inc. (NYSE:BHC) completed the acquisition of DURECT Corporation (NasdaqCM:DRRX).Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. As of August 26, 2025, DURECT Corporation announced the extension of the expiration date of its tender offer. The Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on September 9, 2025, has been extended until 5:00 p.m., New York City time, on September 10, 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation. Equiniti Trust Company, LLC acted as depositary bank to Bausch. Bausch Health Companies Inc. (NYSE:BHC) completed the acquisition of DURECT Corporation (NasdaqCM:DRRX) on September 11, 2025.お知らせ • Jul 29Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million.Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation.お知らせ • Jul 13DURECT Receives Additional 180-Day Grace Period from Nasdaq to Regain Compliance with the Minimum Bid Price RequirementAs previously reported on a Current Report on Form 8-K filed with the Securities and Exchange Commission (the ‘SEC’) on January 10, 2025, DURECT Corporation (the ‘Company’) received a letter (the ‘Notice’) from The Nasdaq Stock Market (‘Nasdaq’), dated January 9, 2025, advising the Company that for 30 consecutive trading days preceding the date of the Notice, the bid price of the Company’s common stock had closed below the $1.00 per share minimum required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). The Notice stated that the Company had 180 days, or until July 8, 2025, to demonstrate its compliance with the Minimum Bid Price Requirement. On July 9, 2025, the Company received approval from the Listing Qualifications Department of Nasdaq for an additional 180-day grace period, or until January 5, 2026, to regain compliance with the Minimum Bid Price Requirement (the ‘Approval’). To regain compliance with the Minimum Bid Price Requirement and qualify for continued listing on The Nasdaq Capital Market, the minimum bid price per share of the Company’s common stock must be at least $1.00 for at least ten consecutive business days during the additional 180-day grace period. If the Company does not regain compliance during this additional grace period, its common stock would be subject to delisting by Nasdaq. As part of its request for an additional 180-day grace period, the Company notified Nasdaq that (i) the Company meets the continued listing standard for market value of publicly-held shares and all other applicable requirements for initial listing standards of The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) if the Company’s stock price does not recover sufficiently during the additional grace period, it anticipates implementing and completing a reverse stock split by no later than December 16, 2025, if necessary. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock during the additional grace period, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the additional grace period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day additional grace period or maintain compliance with the other Nasdaq listing requirements.お知らせ • Mar 20DURECT Corporation to Report Q4, 2024 Results on Mar 26, 2025DURECT Corporation announced that they will report Q4, 2024 results at 4:00 PM, US Eastern Standard Time on Mar 26, 2025お知らせ • Feb 22DURECT Corporation Announces Retirement of Terrence F. Blaschke as Board of Director, Member of the Nominating and Corporate Governance CommitteeOn February 14, 2025, Terrence F. Blaschke announced his intention to retire and submitted his immediately effective resignation from the Board of Directors (the “Board”) of DURECT Corporation (the “Company”), including from his role as a member of the Nominating and Corporate Governance Committee of the Board (the “Nominating Committee”).お知らせ • Jan 29DURECT Corporation Announces Publication of Larsucosterol Phase 2B Results in NEJM EvidenceDURECT Corporation announced the publication of a peer-reviewed article on the AHFIRM trial data in NEJM Evidence. The AHFIRM trial was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study that evaluated the safety and efficacy of the Company's epigenetic modulator, larsucosterol, for the treatment of subjects with severe alcohol-associated hepatitis (AH). It enrolled 307 patients across three arms: placebo, which consisted of standard of care, with or without methylprednisolone capsules at the investigators' discretion, larsucosterol (30 mg) and larsucosterol (90 mg). A total of 62 centers enrolled patients including 46 US sites that enrolled 76% of patients. Topline results from AHFIRM were previously announced by DURECT. Key data highlights from the AHFIRM trial, include: Both the 30 mg and 90 mg larsucosterol doses demonstrated clinically meaningful trends in reducing 90-day mortality with mortality reductions of 41% (p=0.068) in the 30 mg arm and 35% (p=0.124) in the 90 mg arm compared with placebo. The reductions in mortality at 90 days were more pronounced in U.S. patients with reductions of 57% (p=0.014) in the 30 mg arm and 58% (p=0.008) in the 90 mg arm compared with placebo; computations for random sample analysis suggest that the U.S. results of larsucosterol treatment were unlikely to be an artifact of random chance. The numerical improvement in the primary endpoint of mortality or liver transplant at 90 days did not achieve statistical significance for either dose of larsucosterol. Variations in time from hospitalization to first dose highlighted the importance of timely treatment in patients with severe AH. Larsucosterol appeared safe and well tolerated in the AHFIRM trial and the number of treatment emergent adverse events (TEAEs) and newly-occurring significant complications of liver disease in both larsucosterol groups were similar to those in placebo. AHFIRM was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study conducted in subjects with severe alcohol-associated hepatitis (AH) to evaluate the saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study was comprised of three arms and enrolled 307 patients, with approximately 100 patients in each arm: (1) Placebo, which consisted of standard of care, with or without methylprednisolone capsules at the investigators' discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. The primary outcome measure was the 90-day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo, and the key secondary endpoint was 90-day survival. The Company enrolled patients at clinical trial sites across the U.S., EU, U.K., and Australia. In November 2023, the Company announced topline data for the AHFIRM Trial. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation and Breakthrough Therapy Designation for the treatment of AH.お知らせ • Jan 11DURECT Corporation Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price RequirementOn January 9, 2025, DURECT Corporation, a Delaware Corporation (the Company"), received a letter (the Notice") from the Listing Qualifications Department of the Nasdaq Stock Market (Nasdaq") informing the Company that, because the closing bid price for the Company's common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company is not in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set in Nasdaq Marketplace Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from January 9, 2025, or until July 8, 2025, to regain compliance with the Minimum Bid Price Requirement. If at any time before July 8, 2025, the closing bid price of the Company's common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement, and the matter will be resolved. If the Company does not regain compliance during the compliance period ending on July 8, 2025, then Nasdaq may grant the Company a second 180 calendar day grace period to regain compliance, provided the Company (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) the Company notifies Nasdaq of its intent to cure the deficiency. The Company intends to continue actively monitoring the closing bid price for the Company's common stock between now and July 8, 2025, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company's common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 calendar days to regain compliance, or maintain compliance with the other Nasdaq listing requirements.Reported Earnings • Nov 16Third quarter 2024 earnings released: US$0.14 loss per share (vs US$0.11 loss in 3Q 2023)Third quarter 2024 results: US$0.14 loss per share (further deteriorated from US$0.11 loss in 3Q 2023). Revenue: US$1.93m (up 11% from 3Q 2023). Net loss: US$4.29m (loss widened 42% from 3Q 2023). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings.New Risk • Nov 14New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 54% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$26m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 54% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$28m net loss next year). Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Market cap is less than US$100m (€35.7m market cap, or US$37.6m).お知らせ • Nov 07DURECT Corporation to Report Q3, 2024 Results on Nov 13, 2024DURECT Corporation announced that they will report Q3, 2024 results on Nov 13, 2024Reported Earnings • Aug 15Second quarter 2024 earnings released: US$0.12 loss per share (vs US$0.46 loss in 2Q 2023)Second quarter 2024 results: US$0.12 loss per share (improved from US$0.46 loss in 2Q 2023). Revenue: US$2.17m (up 4.3% from 2Q 2023). Net loss: US$3.70m (loss narrowed 67% from 2Q 2023). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings.Board Change • Aug 10Insufficient new directorsThere is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Pete Garcia was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Aug 08DURECT Corporation to Report Q2, 2024 Results on Aug 13, 2024DURECT Corporation announced that they will report Q2, 2024 results on Aug 13, 2024お知らせ • Aug 05DURECT Corporation, Annual General Meeting, Sep 25, 2024DURECT Corporation, Annual General Meeting, Sep 25, 2024.お知らせ • May 09DURECT Corporation to Report Q1, 2024 Results on May 13, 2024DURECT Corporation announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 13, 2024お知らせ • Mar 21DURECT Corporation to Report Q4, 2023 Results on Mar 27, 2024DURECT Corporation announced that they will report Q4, 2023 results on Mar 27, 2024お知らせ • Dec 24DURECT Receives Non-Compliance Notice from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital MarketOn December 21, 2023, DURECT Corporation (the ‘Company’) received a letter (the ‘Notice’) from the Listing Qualifications Department of the Nasdaq Stock Market (‘Nasdaq’) informing the Company that because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from December 21, 2023, or until June 18, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before June 18, 2024, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement, and the matter would be resolved. If the Company does not regain compliance during the compliance period ending on June 18, 2024, then Nasdaq may grant the Company a second 180 calendar day grace period to regain compliance, provided the Company (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) the Company notifies Nasdaq of its intent to cure the deficiency. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock between now and June 18, 2024, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 calendar days to regain compliance, or maintain compliance with the other Nasdaq listing requirements.お知らせ • Nov 10DURECT Corporation to Report Q3, 2023 Results on Nov 13, 2023DURECT Corporation announced that they will report Q3, 2023 results on Nov 13, 2023お知らせ • Nov 08DURECT Corporation Announces Topline Results from Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis with Promising Effect on MortalityDURECT Corporation announced topline results from its AHFIRM trial, a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of larsucosterol in 307 patients with severe alcohol-associated hepatitis (AH). Topline data from AHFIRM showed: Both the 30 mg and 90 mg larsucosterol doses demonstrated a compelling and clinically meaningful trend in reduction of mortality at 90 days, the key secondary endpoint, with mortality reductions of 41% (p=0.070) in the 30 mg arm and 35% (p=0.126) in the 90 mg arm compared with SOC. The numerical improvement in the primary endpoint of mortality or transplant at 90 days did not achieve statistical significance for either dose of larsucosterol. Both doses of larsucosterol showed a more pronounced reduction in mortality in patients enrolled in the U.S., representing 76% of patients enrolled in the trial. The reductions in mortality at 90 days were 57% (p=0.014) for the 30 mg arm and 58% (p=0.008) for the 90 mg arm compared with SOC. Larsucosterol was safe and well tolerated. There were fewer treatment-emergent adverse events (TEAEs) in the larsucosterol arms compared with SOC. DURECT intends to have an End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to discuss the trial results and the Phase 3 registration trial design in the first quarter of 2024. DURECT also intends to present the results of AHFIRM at an upcoming medical meeting. Key AHFIRM trial results: Mortality or Liver Transplantation at 90 Days: The primary endpoint for the AHFIRM trial was the reduction in mortality or liver transplantation at 90 days. The endpoint was analyzed using a hierarchical assessment of patient outcomes to calculate a win probability for each of the 30 mg and 90 mg dose of larsucosterol compared with SOC. The results for the primary endpoint were not statistically significant for either the 30 mg or 90 mg doses compared with SOC, though a numerical improvement was observed. Mortality at 90 Days: Mortality at 90 Days was a key secondary endpoint for the AHFIRM trial. In this analysis, the 30 mg and 90 mg doses of larsucosterol showed numerical trends toward a clinically meaningful survival benefit with 90-day mortality reductions of 41% and 35%, respectively, when compared to SOC, although these results were not statistically significant.Mortality at 90 Days (U.S. patients): When further analyzed by geography, both the 30 mg and 90 mg doses showed an enhanced survival benefit at 90 days with reductions in 90-day mortality of 57% and 58%, respectively, in patients enrolled in the U.S., which represented 76% of the total patients enrolled. Safety and Tolerability: Both the 30 mg and 90 mg doses of larsucosterol were well tolerated. There were fewer TEAEs in the larsucosterol arms compared with SOC.お知らせ • Sep 09Durect Corporation Announces Last Patient Last Visit in Phase 2B Ahfirm Trial of Larsucosterol in Alcohol-Associated HepatitisDURECT Corporation announced that the last patient has completed the study protocol in the Company's AHFIRM trial. AHFIRM is a Phase 2b randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of lasucosterol in subjects with severe alcohol-associated hepatitis (AH). A total of 301 patients were randomized and dosed in AHFIRM and DURECT plans to report topline data in the fourth quarter of 2023.お知らせ • Aug 04DURECT Corporation to Report Q2, 2023 Results on Aug 09, 2023DURECT Corporation announced that they will report Q2, 2023 results on Aug 09, 2023お知らせ • Jun 08DURECT Corporation Completes Enrollment in Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated HepatitisDURECT Corporation announced that it has completed enrollment in its Phase 2b AHFIRM clinical trial (NCT04563026) investigating larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH), achieving its enrollment target of 300 patients. AHFIRM is a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe acute alcohol-associated hepatitis (AH) to evaluate saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study is comprised of three arms evaluating a total of approximately 300 subjects, with approximately 100 patients in each arm: (1) Placebo plus supportive care, with or without methylprednisolone capsules at the investigators’ discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. In order to maintain blinding, patients in the two active arms received matching placebo capsules if the investigator prescribed steroids. The primary outcome measure will be the 90-Day incidence of death or liver transplantation for patients treated with larsucosterol compared to those treated with placebo. The Company has enrolled patients at more than 60 clinical trial sites across the U.S., EU, U.K. and Australia.Reported Earnings • Aug 06Second quarter 2022 earnings released: US$0.051 loss per share (vs US$0.04 loss in 2Q 2021)Second quarter 2022 results: US$0.051 loss per share (down from US$0.04 loss in 2Q 2021). Revenue: US$2.08m (down 9.9% from 2Q 2021). Net loss: US$11.6m (loss widened 26% from 2Q 2021). Over the next year, revenue is forecast to grow 77%, compared to a 5.6% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has fallen by 25% per year, which means it is performing significantly worse than earnings.Board Change • May 31High number of new directorsIndependent Director Pete Garcia was the last director to join the board, commencing their role in 2021.Reported Earnings • May 06First quarter 2022 earnings released: US$0.048 loss per share (vs US$0.047 loss in 1Q 2021)First quarter 2022 results: US$0.048 loss per share (down from US$0.047 loss in 1Q 2021). Revenue: US$1.92m (down 13% from 1Q 2021). Net loss: US$10.8m (loss widened 7.0% from 1Q 2021). Over the next year, revenue is forecast to grow 21%, compared to a 8.1% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has fallen by 7% per year whereas the company’s share price has fallen by 12% per year.Breakeven Date Change • Apr 27No longer forecast to breakevenThe 3 analysts covering DURECT no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$41.2m in 2024. New consensus forecast suggests the company will make a loss of US$10.0m in 2024.Board Change • Apr 27High number of new directorsIndependent Director Pete Garcia was the last director to join the board, commencing their role in 2021.お知らせ • Apr 17DURECT Corporation, Annual General Meeting, Jun 15, 2022DURECT Corporation, Annual General Meeting, Jun 15, 2022, at 09:00 Pacific Standard Time. Agenda: To consider the electing of two Class I directors of its Board of Directors to serve until the 2025 annual meeting of stockholders; to approve an amendment to our Certificate of Incorporation to increase the number of authorized shares of our common stock from 350,000,000 to 600,000,000; to approve the amendment and restatement of the 2000 Stock Plan; to approve executive compensation; and to ratify the appointment of Ernst & Young LLP as the Company's independent registered public accounting firm for the current fiscal year.Recent Insider Transactions • Mar 17Independent Director recently bought €107k worth of stockOn the 14th of March, Judith Robertson bought around 200k shares on-market at roughly €0.54 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €126k more in shares than they have sold in the last 12 months.Breakeven Date Change • Mar 10No longer forecast to breakevenThe 3 analysts covering DURECT no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$41.2m in 2024. New consensus forecast suggests the company will make a loss of US$10.0m in 2024.Reported Earnings • Mar 09Full year 2021 earnings: EPS in line with analyst expectations despite revenue beatFull year 2021 results: US$0.16 loss per share (down from US$0.072 loss in FY 2020). Revenue: US$14.0m (down 54% from FY 2020). Net loss: US$36.3m (loss widened 153% from FY 2020). Revenue exceeded analyst estimates by 59%. Over the next year, revenue is forecast to grow 9.7%, compared to a 8.2% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings.お知らせ • Mar 06DURECT Corporation Announces Resignation of Michael Arenberg as Chief Financial Officer, Effective March 17, 2022On March 3, 2022, DURECT Corporation announced that Michael Arenberg will step down from his role as the Company’s Chief Financial Officer, effective March 17, 2022, to pursue another opportunity in an operating role. The Company has initiated a search to identify a new Chief Financial Officer. Matt Hogan, the Company’s former Chief Financial Officer from 2006-2018, who has continued to serve DURECT as a corporate finance advisor since 2018, will support the Company while the Company conducts its search for Mr. Arenberg’s replacement. Until a permanent replacement for Mr. Arenberg has been named, Jian Li will serve as the Company’s interim Principal Accounting Officer. Ms. Li has served as the Company’s Vice President, Finance and Corporate Controller since December 2003. She is also a certified public accountant and a member of the American Institute of Certified Public Accountants.お知らせ • Mar 03Durect Corporation Doses First European Patient in Phase 2B Ahfirm Study of Larsucosterol(Dur-928) in Severe Alcohol-Associated HepatitisDURECT Corporation announced it dosed the first patient in the European Union as part of its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of larsucosterol in severe alcohol-associated hepatitis patients. Enrollment is ongoing in Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe acute alcohol-associated hepatitis to evaluate safety and efficacy of laRsucosterol treatMent. The study is comprised of three arms targeting enrollment of 300 total patients, with approximately 100 patients in each arm: Placebo plus standard of care which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician; larsucosterol; and larsucosterol . All patients in the trial receive supportive care. The primary outcome measure is 90-day survival rate for patients treated with larsucosterol compared to those treated with placebo plus SOC. The Company is targeting more than 60 clinical trial sites across the U.S., EU, U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration has granted larsucosterol Fast Track Designation for the treatment of AH. Believe demonstration of a robust survival benefit in the AHFIRM trial would support an NDA filing. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026. AH is a life-threatening acute alcohol-associated liver disease often caused by chronic heavy alcohol use and a recent period of increased alcohol consumption . It is characterized by severe inflammation and destruction of liver tissue, potentially leading to life-threatening complications, including liver failure, acute renal injury and multi-organ failure. There are no FDA approved therapies for AH and an analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median MELD score of 23.5, reported mortality at 28 and 90 days of 20% and 30.9% respectively. Stopping alcohol consumption is not sufficient for recovery in many moderate and severe patients and the use of treatments to reduce liver inflammation, such as corticosteroids, are limited by contraindications and have been shown to provide no survival benefit at 90 days or 1 year. While liver transplantation is becoming more common for alcoholic liver disease patients, including for AH patients, the procedure involves a long waiting period, a burdensome selection process and costs more than $875,000 on average.お知らせ • Mar 01DURECT Corporation to Report Q4, 2021 Results on Mar 07, 2022DURECT Corporation announced that they will report Q4, 2021 results After-Market on Mar 07, 2022Board Change • Jan 02High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Director Pete Garcia was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.Breakeven Date Change • Jan 01Forecast to breakeven in 2024The 3 analysts covering DURECT expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$41.2m in 2024. Average annual earnings growth of 65% is required to achieve expected profit on schedule.Reported Earnings • Nov 04Third quarter 2021 earnings released: US$0.044 loss per share (vs US$0.046 loss in 3Q 2020)The company reported a poor third quarter result with increased losses, weaker revenues and weaker control over costs. Third quarter 2021 results: Revenue: US$2.17m (down 19% from 3Q 2020). Net loss: US$9.98m (loss widened 6.9% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has increased by 9% per year, which means it is tracking significantly ahead of earnings growth.Reported Earnings • Jul 31Second quarter 2021 earnings released: US$0.04 loss per share (vs US$0.073 profit in 2Q 2020)The company reported a poor second quarter result with weaker earnings, revenues and control over costs. Second quarter 2021 results: Revenue: US$2.30m (down 91% from 2Q 2020). Net loss: US$9.15m (down 164% from profit in 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 3% per year and the company’s share price has also fallen by 3% per year.Breakeven Date Change • Jun 25Forecast to breakeven in 2024The 4 analysts covering DURECT expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$36.8m in 2024. Average annual earnings growth of 73% is required to achieve expected profit on schedule.お知らせ • Jun 24DURECT Corporation Presents Additional Clinical Data from DUR-928 Phase 1b Trial in NASH and Phase 1 Trial in Hepatic Impairment at the International Liver Conference 2021DURECT Corporation announced the presentation of additional clinical data from a DUR-928 Phase 1b trial in non-alcoholic steatohepatitis (NASH) and a Phase 1 trial in subjects with hepatic impairment (HI) as part of two posters at the 2021 International Liver Conference (EASL) being held virtually June 23-26, 2021. Poster #1198 entitled "Efficacy Signals of 4-Week Oral DUR-928 in NASH Subjects," presented by Eric Lawitz, M.D., Vice President, Scientific and Research Development, Texas Liver Institute, disclosed additional potential efficacy signals from DURECT's Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients. Key highlights include: Improvement from baseline in insulin resistance as assessed by the homeostatic model assessment (HOMA-IR). Subjects in the 50 mg and 150 mg groups had 22% and 18% median reductions (not statistically significant) of HOMA-IR from baseline respectively after 4 weeks of daily oral dosing of DUR-928. Subjects in the 600 mg group did not show a change in HOMA-IR. Improvement from baseline in liver stiffness, assessed by transient elastography (TE), magnetic resonance elastography (MRE) and the liver fibrosis marker pro-C3. Previously reported data showed improvement from baseline in: liver enzymes such as ALT, AST and GGT and improvements in serum lipid profiles such as LDL-C, non-HDLC and triglycerides; liver fat by MRI-PDFF imaging; and biomarkers of liver health, such as CK-18, a cell death biomarker, certain of which were statistically significant improvements. Safety profile: DUR-928 was safe and well tolerated by all subjects in the study. Data highlights from Poster #668 entitled "Safety and Pharmacokinetics of DUR-928 in Hepatic Function Impaired Subjects," presented by Jaymin Shah, Ph.D., Executive Director, Clinical Pharmacology and Pharmacokinetics at DURECT, included: Safety profile: DUR-928 was safe and well-tolerated by all moderate and severe hepatic impairment (HI) subjects with no adverse events and no dose-limiting toxicity reported throughout the study. Pharmacokinetics: As expected, clearance of DUR-928 was decreased in HI subjects compared to matched control subjects with normal hepatic function, leading to a 4-10 fold higher drug exposure (Cmax and AUC) in HI subjects depending on the severity of HI. Initial efficacy signals: A single oral dose of 200 mg of DUR-928 in subjects with HI resulted in statistically significant median reductions from baseline of the apoptosis biomarker M30 (cCK-18) at 12 hours post-dose.お知らせ • Jun 10DURECT Corporation to Present Additional Clinical Data from DUR-928 Studies in NASH and in Hepatic Impairment At Upcoming International Liver Conference 2021DURECT Corporation announced it will present two posters at the 2021 International Liver Conference to be held virtually June 23-26, 2021. The first poster will discuss additional efficacy signals from a Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis patients. Previously reported data showed that DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day) with overall improvement from baseline observed in liver enzymes, serum lipid profiles, liver fat by imaging, and biomarkers of liver health. The poster will feature additional efficacy signal data including liver stiffness by transient elastography and magnetic resonance elastography, liver fibrosis marker, pro-C3, and ELF scores, as well as insulin resistance. A second poster will provide data from a Phase 1 study assessing the safety, tolerability, pharmacokinetics of DUR-928 in subjects with moderate and severe hepatic impairment, who received a single oral dose of 200mg DUR-928.お知らせ • Mar 10Durect Corporation Announces Publication of Dur-928'S Mechanism of ActionDURECT Corporation announced the publication of a peer-reviewed research paper describing the binding sites and proposed mechanism of action of its lead drug candidate, an endogenous sulfated oxysterol and epigenetic regulator, DUR-928, in The Journal of Lipid Research. DUR-928 is an endogenous sulfated oxysterol that acts as an epigenetic regulator, a compound that regulates patterns of gene expression without modifying the DNA sequence. The publication shows that DUR-928 (referred to in the paper as 25HC3S) binds to and inhibits the activity of DNA methyltransferases (DNMTs), DNMT-1, 3a and 3b, epigenetic regulating enzymes that add methyl groups to DNA (a process called DNA methylation). As such, by inhibiting DNMT activity, DUR-928 inhibits DNA methylation, thereby regulating the expression of genes that modulate crucial cellular activities, including those associated with cell death, stress response, and lipid biosynthesis. These modulations may lead to improved cell survival, and reduced lipid accumulation and inflammation, as has been observed in various in vivo animal models and in results from DURECT's completed clinical trials in alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis (NASH). In a Phase 2a clinical trial in patients with AH, 100% of patients treated with DUR-928 survived the 28-day follow-up period compared to a 26% historical average 28-day mortality rate. 74% of patients treated with DUR-928 were discharged within 4 days or less of treatment after one dose. In a Phase 1b trial, patients with NASH treated with DUR-928 experienced significant improvements in biomarkers of liver function and liver health, including liver enzymes and serum lipid profiles. A reduction in liver fat of more than 10% was observed in 43% of these patients.お知らせ • Feb 26DURECT Corporation to Report Q4, 2020 Results on Mar 04, 2021DURECT Corporation announced that they will report Q4, 2020 results After-Market on Mar 04, 2021お知らせ • Feb 03DURECT Corporation Announces U.S. FDA Approval of POSIMIR® for Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial DecompressionDURECT Corporation announced that the U.S. Food and Drug Administration (FDA) has approved POSIMIR® (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opbioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01).お知らせ • Jan 28DURECT Corporation Announces First Patient Dosed in Phase 2b AHFIRM Study of DUR-928 in Severe Alcohol-Associated HepatitisDURECT Corporation announced it has dosed the first patient in its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in severe alcohol-associated hepatitis (AH) patients. AHFIRM is a Phase 2b clinical trial evaluating the potential life-saving capacity of DUR-928 in patients with severe AH. AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores), and time in the intensive care unit. The Company is targeting 40-50 clinical trial sites in the US and Europe. Alcohol-Associated Hepatitis (also called Alcoholic Hepatitis or AH) is an acute form of alcohol-associated liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by recent onset jaundice and hepatic failure. According to the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 122,000 hospitalizations for patients with AH in 2017. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days after admission. DURECT's lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.お知らせ • Jan 06DURECT Corporation Announces Board ChangesDURECT Corporation announced that the Board of Directors of DURECT has appointed, effective as of January 4, 2021 Ms. Gail Maderis as a Class I director of DURECT with a term to expire at the 2022 Annual Meeting of Stockholders and Dr. Mohammed Azab as a Class III director of DURECT with a term to expire at the 2021 Annual Meeting of Stockholders. In connection with the appointments, the Board approved an increase in the size of the Board, from eight to ten members, effective as of the Effective Date. Ms. Gail Maderis has served as the President, Chief Executive Officer and a board member of Antiva BioSciences Inc. Prior to that, Ms. Maderis served as the President and Chief Executive Officer of BayBio. Dr. Azab served as President and Chief Medical Officer of Astex Pharmaceuticals Inc. from January 2014 to November 2020, and prior to that, he had served as Astex’s Chief Medical Officer from July 2009 to January 2014.お知らせ • Jan 05DURECT Corporation Announces Closing of LACTEL® Absorbable Polymer Product Line Sale to Evonik and Receipt of $15 MillionDURECT Corporation announced that the sale of the LACTEL product line to Evonik closed and the $15 million payment was received on December 31, 2020.お知らせ • Dec 18DURECT Corporation Announces Dur-928 Granted Fda Fast Track Designation for Treatment of Alcoholic HepatitisDURECT Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to DUR-928 for the treatment of alcoholic hepatitis (AH, also known as alcohol-associated hepatitis). AH is an acute, life-threatening form of alcohol-associated liver disease (ALD). DUR-928 is the lead investigational product candidate in DURECT's Epigenetic Regulator program. The FDA grants Fast Track Designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track Designation can benefit from early and frequent communication with the agency in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.お知らせ • Nov 14DURECT Corporation Announces Additional Safety Data and Efficacy Signals from Phase 1b Clinical Trial of DUR-928 in NASH Patients at The Liver Meeting Digital Experience 2020DURECT Corporation presented additional safety data and efficacy signals from its Phase 1b clinical trial of DUR-928 in nonalcoholic steatohepatitis (NASH) patients in a poster presentation at The AASLD Liver Meeting Digital Experience ™ (TLMdX) 2020. The study was a randomized, open label, multi center US study to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in NASH patients with stage 1-3 fibrosis. A total of 65 patients completed the study. DUR-928 was orally administered daily at 50 mg (n=23), 150 mg (n=21), or 600 mg (300 mg BID (n=21)). Patients in this trial were dosed daily for 4 weeks and followed up for an additional 4 weeks. DURECT's lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival. Nonalcoholic steatohepatitis (NASH) is the most severe and progressive form of nonalcoholic fatty liver disease (NAFLD) and the most common chronic liver disease worldwide, with an estimated prevalence of more than 10% of adults in the United States, Europe, Japan, and other developed countries, expected to double by 2030. No drug is currently approved for treatment of NAFLD or NASH.お知らせ • Nov 11DURECT Corporation Appoints Norman Sussman as Chief Medical OfficerDURECT Corporation announced that Norman Sussman, MD, FAASLD, newly appointed Chief Medical Officer. Dr. Sussman will be available to answer questions following the formal presentations. Norman L. Sussman, MD, FAASLD, joined DURECT as Chief Medical Officer in November 2020. He has extensive clinical experience and expertise in the field of liver disease and brings over 30 years of clinical research and development experience in academia and industry. Prior to joining DURECT he was an Associate Professor of Medicine and Surgery at Baylor College of Medicine and a faculty member of Baylor College of Medicine intermittently since 1985. During that time, he served as a Principal Investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman gained leadership experience in industry as the founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix Inc. from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as Director of the telehealth program, Project ECHO®, at Baylor St. Luke's Medical Center.お知らせ • Nov 03DURECT Corporation Appoints Norman Sussman as Chief Medical OfficerDURECT Corporation announced it has appointed Norman Sussman, M.D. as its Chief Medical Officer, effective immediately. In this new role, Dr. Sussman will oversee the clinical development of DURECT's pipeline including multiple indications for its lead investigational drug candidate DUR-928. Dr. Sussman has extensive clinical experience and expertise in the liver disease field and brings over 30 years of clinical research and development experience in academia and industry. He joins DURECT from Baylor College of Medicine, where he was an Associate Professor of Medicine and Surgery. Dr. Sussman has been a faculty member of Baylor College of Medicine intermittently since 1985. During this time, he has served as a Principal Investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman has also had leadership experience in industry as the founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix Inc. from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as Director of the telehealth program, Project ECHO®, at Baylor St. Luke's Medical Center.お知らせ • Oct 28DURECT Corporation to Report Q3, 2020 Results on Nov 02, 2020DURECT Corporation announced that they will report Q3, 2020 results on Nov 02, 2020お知らせ • Oct 06DURECT Corporation to Present Additional Safety and Efficacy Signals from Phase 1B Clinical Trial of Dur-928 in Nash Patients At the Liver Meeting Digital Experience 2020DURECT Corporation to present additional safety and efficacy signals from Phase 1B Clinical Trial of Dur-928 in Nash Patients At the Liver Meeting Digital Experience 2020. Topline results from the 4-week Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients were released previously, showing an overall improvement from baseline in liver enzymes, liver stiffness, and serum lipid profiles. At day 28, 43% of patients showed = 10% liver fat reduction from baseline as measured by magnetic resonance imaging - proton density fat fraction (MRI-PDFF). Daily oral dosing of DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day). Additional safety and efficacy data will be presented in the poster.お知らせ • Sep 24DURECT Corporation Announces First Patient Dosed in Phase 2 Safety and Efficacy Study of DUR-928 in COVID-19 Patients with Acute Liver or Kidney InjuryDURECT Corporation announced it has dosed the first patient in its randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury. The primary efficacy endpoint is a composite of survival and being free of acute organ failure at Day 28. The company plans to enroll approximately 80 patients in multiple study sites across the U.S. This Phase 2, randomized, double-blind, placebo-controlled, multi-center study is designed to evaluate safety and efficacy of DUR-928 in COVID-19 patients with acute liver or kidney injury. A total of approximately 80 patients are planned to be enrolled into two study treatment groups in a 3:1 (DUR-928: placebo) ratio. Patients will receive a dose of 150 mg of DUR-928 or placebo by intravenous infusion on day 1 and day 4 in combination with standard of care therapy, which will be determined by the principal investigator (PI) at each clinical trial site. The primary efficacy endpoint is a composite of survival and being free of acute organ failure (free of mechanical ventilation, free of liver failure events and free of renal replacement therapy) at day 28. Patients will be followed for 60 days. Should any drug product be determined by the FDA to be safe and effective for the treatment of COVID-19 while the trial is ongoing, such treatments may be offered, at each PI's discretion, to any remaining and future patients in this trial.お知らせ • Sep 23Durect Corporation Announces the Study Design for the Phase 2B Ahfirm Clinical Trial of DUR-928 in Severe Alcoholic Hepatitis (AH) PatientsDURECT Corporation announced the study design for the Phase 2b AHFIRM clinical trial of DUR-928 in severe alcoholic hepatitis (AH) patients. AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in the intensive care unit. The Company is targeting 40-45 clinical trial sites in the US and Europe and anticipates trial initiation in October. DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.株主還元DC8ADE PharmaceuticalsDE 市場7D-0.6%3.4%0.6%1Y16.8%26.6%0.2%株主還元を見る業界別リターン: DC8A過去 1 年間で26.6 % の収益を上げたGerman Pharmaceuticals業界を上回りました。リターン対市場: DC8Aは、過去 1 年間で0.2 % のリターンをもたらしたGermanマーケットと一致しました。価格変動Is DC8A's price volatile compared to industry and market?DC8A volatilityDC8A Average Weekly Movement73.6%Pharmaceuticals Industry Average Movement6.3%Market Average Movement6.1%10% most volatile stocks in DE Market13.2%10% least volatile stocks in DE Market2.7%安定した株価: DC8A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: DC8Aの 週次ボラティリティ は、過去 1 年間で39%から74%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199813Jim Brownwww.durect.comDURECT Corporationは、エピジェネティックレギュレーター・プログラムに基づき医薬品を開発するバイオ医薬品企業である。同社の主要製品候補には、脂質代謝、ストレス・炎症反応、細胞死・生存において調節的役割を果たす内因性経口生物学的利用可能な低分子化合物であるラルスコステロールがあり、アルコール関連肝炎の治療や代謝機能障害関連脂肪性肝炎患者の治療に使用される。また、成人患者を対象に3日間にわたりブピバカインを投与する術後疼痛治療薬POSIMIR、成人の統合失調症治療用注射懸濁液PERSERIS、注意欠陥多動性障害治療薬Methydurも提供している。バージニア・コモンウェルス大学知的財産財団およびイノコール・ファーマシューティカルズ・リミテッドと戦略的提携などの契約を結んでいる。DURECT Corporationは1998年に設立され、カリフォルニア州クパチーノに本社を置いている。もっと見るDURECT Corporation 基礎のまとめDURECT の収益と売上を時価総額と比較するとどうか。DC8A 基礎統計学時価総額€51.23m収益（TTM）-€11.19m売上高(TTM)€1.42m35.8xP/Sレシオ-4.5xPER（株価収益率DC8A 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DC8A 損益計算書（TTM）収益US$1.66m売上原価-US$2.50m売上総利益US$4.16mその他の費用US$17.26m収益-US$13.09m直近の収益報告Jun 30, 2025次回決算日該当なし一株当たり利益（EPS）-0.42グロス・マージン251.12%純利益率-790.28%有利子負債／自己資本比率0%DC8A 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2025/09/10 18:33終値2025/09/10 00:00収益2025/06/30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DURECT Corporation 1 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。8 アナリスト機関Mayank MamtaniB. Riley Securities, Inc.François BriseboisCraig-Hallum Capital Group LLCDavid WindleyJefferies LLC5 その他のアナリストを表示
お知らせ • Sep 22DURECT Corporation Files Form 15DURECT Corporation has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.0001 per share.
お知らせ • Sep 13DURECT Corporation(NasdaqCM:DRRX) dropped from NASDAQ Composite IndexDURECT Corporation has been dropped from the NASDAQ Composite Index
お知らせ • Sep 11+ 1 more updateBausch Health Companies Inc. (NYSE:BHC) completed the acquisition of DURECT Corporation (NasdaqCM:DRRX).Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. As of August 26, 2025, DURECT Corporation announced the extension of the expiration date of its tender offer. The Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on September 9, 2025, has been extended until 5:00 p.m., New York City time, on September 10, 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation. Equiniti Trust Company, LLC acted as depositary bank to Bausch. Bausch Health Companies Inc. (NYSE:BHC) completed the acquisition of DURECT Corporation (NasdaqCM:DRRX) on September 11, 2025.
お知らせ • Jul 29Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million.Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation.
お知らせ • Jul 13DURECT Receives Additional 180-Day Grace Period from Nasdaq to Regain Compliance with the Minimum Bid Price RequirementAs previously reported on a Current Report on Form 8-K filed with the Securities and Exchange Commission (the ‘SEC’) on January 10, 2025, DURECT Corporation (the ‘Company’) received a letter (the ‘Notice’) from The Nasdaq Stock Market (‘Nasdaq’), dated January 9, 2025, advising the Company that for 30 consecutive trading days preceding the date of the Notice, the bid price of the Company’s common stock had closed below the $1.00 per share minimum required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). The Notice stated that the Company had 180 days, or until July 8, 2025, to demonstrate its compliance with the Minimum Bid Price Requirement. On July 9, 2025, the Company received approval from the Listing Qualifications Department of Nasdaq for an additional 180-day grace period, or until January 5, 2026, to regain compliance with the Minimum Bid Price Requirement (the ‘Approval’). To regain compliance with the Minimum Bid Price Requirement and qualify for continued listing on The Nasdaq Capital Market, the minimum bid price per share of the Company’s common stock must be at least $1.00 for at least ten consecutive business days during the additional 180-day grace period. If the Company does not regain compliance during this additional grace period, its common stock would be subject to delisting by Nasdaq. As part of its request for an additional 180-day grace period, the Company notified Nasdaq that (i) the Company meets the continued listing standard for market value of publicly-held shares and all other applicable requirements for initial listing standards of The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) if the Company’s stock price does not recover sufficiently during the additional grace period, it anticipates implementing and completing a reverse stock split by no later than December 16, 2025, if necessary. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock during the additional grace period, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the additional grace period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day additional grace period or maintain compliance with the other Nasdaq listing requirements.
お知らせ • Mar 20DURECT Corporation to Report Q4, 2024 Results on Mar 26, 2025DURECT Corporation announced that they will report Q4, 2024 results at 4:00 PM, US Eastern Standard Time on Mar 26, 2025
お知らせ • Sep 22DURECT Corporation Files Form 15DURECT Corporation has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.0001 per share.
お知らせ • Sep 13DURECT Corporation(NasdaqCM:DRRX) dropped from NASDAQ Composite IndexDURECT Corporation has been dropped from the NASDAQ Composite Index
お知らせ • Sep 11+ 1 more updateBausch Health Companies Inc. (NYSE:BHC) completed the acquisition of DURECT Corporation (NasdaqCM:DRRX).Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. As of August 26, 2025, DURECT Corporation announced the extension of the expiration date of its tender offer. The Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on September 9, 2025, has been extended until 5:00 p.m., New York City time, on September 10, 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation. Equiniti Trust Company, LLC acted as depositary bank to Bausch. Bausch Health Companies Inc. (NYSE:BHC) completed the acquisition of DURECT Corporation (NasdaqCM:DRRX) on September 11, 2025.
お知らせ • Jul 29Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million.Bausch Health Companies Inc. (NYSE:BHC) entered into an Agreement and Plan of Merger to acquire DURECT Corporation (NasdaqCM:DRRX) for $55.5 million on July 28, 2025. Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate. Sell side termination fee is $3.5 million. The transaction has been approved by the target and acquirer board of directors. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. Centerview Partners LLC is serving as exclusive financial advisor and Allison S. Ressler and Scott B. Crofton of Sullivan & Cromwell LLP acted as legal advisor to Bausch Health Americas, Inc. Locust Walk is serving as exclusive financial advisor and Stephen Thau and David Schwartz of Orrick, Herrington and Sutcliffe LLP acted as legal advisor to DURECT Corporation.
お知らせ • Jul 13DURECT Receives Additional 180-Day Grace Period from Nasdaq to Regain Compliance with the Minimum Bid Price RequirementAs previously reported on a Current Report on Form 8-K filed with the Securities and Exchange Commission (the ‘SEC’) on January 10, 2025, DURECT Corporation (the ‘Company’) received a letter (the ‘Notice’) from The Nasdaq Stock Market (‘Nasdaq’), dated January 9, 2025, advising the Company that for 30 consecutive trading days preceding the date of the Notice, the bid price of the Company’s common stock had closed below the $1.00 per share minimum required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). The Notice stated that the Company had 180 days, or until July 8, 2025, to demonstrate its compliance with the Minimum Bid Price Requirement. On July 9, 2025, the Company received approval from the Listing Qualifications Department of Nasdaq for an additional 180-day grace period, or until January 5, 2026, to regain compliance with the Minimum Bid Price Requirement (the ‘Approval’). To regain compliance with the Minimum Bid Price Requirement and qualify for continued listing on The Nasdaq Capital Market, the minimum bid price per share of the Company’s common stock must be at least $1.00 for at least ten consecutive business days during the additional 180-day grace period. If the Company does not regain compliance during this additional grace period, its common stock would be subject to delisting by Nasdaq. As part of its request for an additional 180-day grace period, the Company notified Nasdaq that (i) the Company meets the continued listing standard for market value of publicly-held shares and all other applicable requirements for initial listing standards of The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) if the Company’s stock price does not recover sufficiently during the additional grace period, it anticipates implementing and completing a reverse stock split by no later than December 16, 2025, if necessary. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock during the additional grace period, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the additional grace period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day additional grace period or maintain compliance with the other Nasdaq listing requirements.
お知らせ • Mar 20DURECT Corporation to Report Q4, 2024 Results on Mar 26, 2025DURECT Corporation announced that they will report Q4, 2024 results at 4:00 PM, US Eastern Standard Time on Mar 26, 2025
お知らせ • Feb 22DURECT Corporation Announces Retirement of Terrence F. Blaschke as Board of Director, Member of the Nominating and Corporate Governance CommitteeOn February 14, 2025, Terrence F. Blaschke announced his intention to retire and submitted his immediately effective resignation from the Board of Directors (the “Board”) of DURECT Corporation (the “Company”), including from his role as a member of the Nominating and Corporate Governance Committee of the Board (the “Nominating Committee”).
お知らせ • Jan 29DURECT Corporation Announces Publication of Larsucosterol Phase 2B Results in NEJM EvidenceDURECT Corporation announced the publication of a peer-reviewed article on the AHFIRM trial data in NEJM Evidence. The AHFIRM trial was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study that evaluated the safety and efficacy of the Company's epigenetic modulator, larsucosterol, for the treatment of subjects with severe alcohol-associated hepatitis (AH). It enrolled 307 patients across three arms: placebo, which consisted of standard of care, with or without methylprednisolone capsules at the investigators' discretion, larsucosterol (30 mg) and larsucosterol (90 mg). A total of 62 centers enrolled patients including 46 US sites that enrolled 76% of patients. Topline results from AHFIRM were previously announced by DURECT. Key data highlights from the AHFIRM trial, include: Both the 30 mg and 90 mg larsucosterol doses demonstrated clinically meaningful trends in reducing 90-day mortality with mortality reductions of 41% (p=0.068) in the 30 mg arm and 35% (p=0.124) in the 90 mg arm compared with placebo. The reductions in mortality at 90 days were more pronounced in U.S. patients with reductions of 57% (p=0.014) in the 30 mg arm and 58% (p=0.008) in the 90 mg arm compared with placebo; computations for random sample analysis suggest that the U.S. results of larsucosterol treatment were unlikely to be an artifact of random chance. The numerical improvement in the primary endpoint of mortality or liver transplant at 90 days did not achieve statistical significance for either dose of larsucosterol. Variations in time from hospitalization to first dose highlighted the importance of timely treatment in patients with severe AH. Larsucosterol appeared safe and well tolerated in the AHFIRM trial and the number of treatment emergent adverse events (TEAEs) and newly-occurring significant complications of liver disease in both larsucosterol groups were similar to those in placebo. AHFIRM was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study conducted in subjects with severe alcohol-associated hepatitis (AH) to evaluate the saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study was comprised of three arms and enrolled 307 patients, with approximately 100 patients in each arm: (1) Placebo, which consisted of standard of care, with or without methylprednisolone capsules at the investigators' discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. The primary outcome measure was the 90-day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo, and the key secondary endpoint was 90-day survival. The Company enrolled patients at clinical trial sites across the U.S., EU, U.K., and Australia. In November 2023, the Company announced topline data for the AHFIRM Trial. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation and Breakthrough Therapy Designation for the treatment of AH.
お知らせ • Jan 11DURECT Corporation Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price RequirementOn January 9, 2025, DURECT Corporation, a Delaware Corporation (the Company"), received a letter (the Notice") from the Listing Qualifications Department of the Nasdaq Stock Market (Nasdaq") informing the Company that, because the closing bid price for the Company's common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company is not in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set in Nasdaq Marketplace Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from January 9, 2025, or until July 8, 2025, to regain compliance with the Minimum Bid Price Requirement. If at any time before July 8, 2025, the closing bid price of the Company's common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement, and the matter will be resolved. If the Company does not regain compliance during the compliance period ending on July 8, 2025, then Nasdaq may grant the Company a second 180 calendar day grace period to regain compliance, provided the Company (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) the Company notifies Nasdaq of its intent to cure the deficiency. The Company intends to continue actively monitoring the closing bid price for the Company's common stock between now and July 8, 2025, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company's common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 calendar days to regain compliance, or maintain compliance with the other Nasdaq listing requirements.
Reported Earnings • Nov 16Third quarter 2024 earnings released: US$0.14 loss per share (vs US$0.11 loss in 3Q 2023)Third quarter 2024 results: US$0.14 loss per share (further deteriorated from US$0.11 loss in 3Q 2023). Revenue: US$1.93m (up 11% from 3Q 2023). Net loss: US$4.29m (loss widened 42% from 3Q 2023). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings.
New Risk • Nov 14New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 54% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$26m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 54% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$28m net loss next year). Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Market cap is less than US$100m (€35.7m market cap, or US$37.6m).
お知らせ • Nov 07DURECT Corporation to Report Q3, 2024 Results on Nov 13, 2024DURECT Corporation announced that they will report Q3, 2024 results on Nov 13, 2024
Reported Earnings • Aug 15Second quarter 2024 earnings released: US$0.12 loss per share (vs US$0.46 loss in 2Q 2023)Second quarter 2024 results: US$0.12 loss per share (improved from US$0.46 loss in 2Q 2023). Revenue: US$2.17m (up 4.3% from 2Q 2023). Net loss: US$3.70m (loss narrowed 67% from 2Q 2023). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings.
Board Change • Aug 10Insufficient new directorsThere is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Pete Garcia was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Aug 08DURECT Corporation to Report Q2, 2024 Results on Aug 13, 2024DURECT Corporation announced that they will report Q2, 2024 results on Aug 13, 2024
お知らせ • Aug 05DURECT Corporation, Annual General Meeting, Sep 25, 2024DURECT Corporation, Annual General Meeting, Sep 25, 2024.
お知らせ • May 09DURECT Corporation to Report Q1, 2024 Results on May 13, 2024DURECT Corporation announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 13, 2024
お知らせ • Mar 21DURECT Corporation to Report Q4, 2023 Results on Mar 27, 2024DURECT Corporation announced that they will report Q4, 2023 results on Mar 27, 2024
お知らせ • Dec 24DURECT Receives Non-Compliance Notice from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital MarketOn December 21, 2023, DURECT Corporation (the ‘Company’) received a letter (the ‘Notice’) from the Listing Qualifications Department of the Nasdaq Stock Market (‘Nasdaq’) informing the Company that because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from December 21, 2023, or until June 18, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before June 18, 2024, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement, and the matter would be resolved. If the Company does not regain compliance during the compliance period ending on June 18, 2024, then Nasdaq may grant the Company a second 180 calendar day grace period to regain compliance, provided the Company (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market, other than the Minimum Bid Price Requirement, and (ii) the Company notifies Nasdaq of its intent to cure the deficiency. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock between now and June 18, 2024, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 calendar days to regain compliance, or maintain compliance with the other Nasdaq listing requirements.
お知らせ • Nov 10DURECT Corporation to Report Q3, 2023 Results on Nov 13, 2023DURECT Corporation announced that they will report Q3, 2023 results on Nov 13, 2023
お知らせ • Nov 08DURECT Corporation Announces Topline Results from Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis with Promising Effect on MortalityDURECT Corporation announced topline results from its AHFIRM trial, a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of larsucosterol in 307 patients with severe alcohol-associated hepatitis (AH). Topline data from AHFIRM showed: Both the 30 mg and 90 mg larsucosterol doses demonstrated a compelling and clinically meaningful trend in reduction of mortality at 90 days, the key secondary endpoint, with mortality reductions of 41% (p=0.070) in the 30 mg arm and 35% (p=0.126) in the 90 mg arm compared with SOC. The numerical improvement in the primary endpoint of mortality or transplant at 90 days did not achieve statistical significance for either dose of larsucosterol. Both doses of larsucosterol showed a more pronounced reduction in mortality in patients enrolled in the U.S., representing 76% of patients enrolled in the trial. The reductions in mortality at 90 days were 57% (p=0.014) for the 30 mg arm and 58% (p=0.008) for the 90 mg arm compared with SOC. Larsucosterol was safe and well tolerated. There were fewer treatment-emergent adverse events (TEAEs) in the larsucosterol arms compared with SOC. DURECT intends to have an End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to discuss the trial results and the Phase 3 registration trial design in the first quarter of 2024. DURECT also intends to present the results of AHFIRM at an upcoming medical meeting. Key AHFIRM trial results: Mortality or Liver Transplantation at 90 Days: The primary endpoint for the AHFIRM trial was the reduction in mortality or liver transplantation at 90 days. The endpoint was analyzed using a hierarchical assessment of patient outcomes to calculate a win probability for each of the 30 mg and 90 mg dose of larsucosterol compared with SOC. The results for the primary endpoint were not statistically significant for either the 30 mg or 90 mg doses compared with SOC, though a numerical improvement was observed. Mortality at 90 Days: Mortality at 90 Days was a key secondary endpoint for the AHFIRM trial. In this analysis, the 30 mg and 90 mg doses of larsucosterol showed numerical trends toward a clinically meaningful survival benefit with 90-day mortality reductions of 41% and 35%, respectively, when compared to SOC, although these results were not statistically significant.Mortality at 90 Days (U.S. patients): When further analyzed by geography, both the 30 mg and 90 mg doses showed an enhanced survival benefit at 90 days with reductions in 90-day mortality of 57% and 58%, respectively, in patients enrolled in the U.S., which represented 76% of the total patients enrolled. Safety and Tolerability: Both the 30 mg and 90 mg doses of larsucosterol were well tolerated. There were fewer TEAEs in the larsucosterol arms compared with SOC.
お知らせ • Sep 09Durect Corporation Announces Last Patient Last Visit in Phase 2B Ahfirm Trial of Larsucosterol in Alcohol-Associated HepatitisDURECT Corporation announced that the last patient has completed the study protocol in the Company's AHFIRM trial. AHFIRM is a Phase 2b randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of lasucosterol in subjects with severe alcohol-associated hepatitis (AH). A total of 301 patients were randomized and dosed in AHFIRM and DURECT plans to report topline data in the fourth quarter of 2023.
お知らせ • Aug 04DURECT Corporation to Report Q2, 2023 Results on Aug 09, 2023DURECT Corporation announced that they will report Q2, 2023 results on Aug 09, 2023
お知らせ • Jun 08DURECT Corporation Completes Enrollment in Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated HepatitisDURECT Corporation announced that it has completed enrollment in its Phase 2b AHFIRM clinical trial (NCT04563026) investigating larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH), achieving its enrollment target of 300 patients. AHFIRM is a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe acute alcohol-associated hepatitis (AH) to evaluate saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study is comprised of three arms evaluating a total of approximately 300 subjects, with approximately 100 patients in each arm: (1) Placebo plus supportive care, with or without methylprednisolone capsules at the investigators’ discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. In order to maintain blinding, patients in the two active arms received matching placebo capsules if the investigator prescribed steroids. The primary outcome measure will be the 90-Day incidence of death or liver transplantation for patients treated with larsucosterol compared to those treated with placebo. The Company has enrolled patients at more than 60 clinical trial sites across the U.S., EU, U.K. and Australia.
Reported Earnings • Aug 06Second quarter 2022 earnings released: US$0.051 loss per share (vs US$0.04 loss in 2Q 2021)Second quarter 2022 results: US$0.051 loss per share (down from US$0.04 loss in 2Q 2021). Revenue: US$2.08m (down 9.9% from 2Q 2021). Net loss: US$11.6m (loss widened 26% from 2Q 2021). Over the next year, revenue is forecast to grow 77%, compared to a 5.6% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has fallen by 25% per year, which means it is performing significantly worse than earnings.
Board Change • May 31High number of new directorsIndependent Director Pete Garcia was the last director to join the board, commencing their role in 2021.
Reported Earnings • May 06First quarter 2022 earnings released: US$0.048 loss per share (vs US$0.047 loss in 1Q 2021)First quarter 2022 results: US$0.048 loss per share (down from US$0.047 loss in 1Q 2021). Revenue: US$1.92m (down 13% from 1Q 2021). Net loss: US$10.8m (loss widened 7.0% from 1Q 2021). Over the next year, revenue is forecast to grow 21%, compared to a 8.1% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has fallen by 7% per year whereas the company’s share price has fallen by 12% per year.
Breakeven Date Change • Apr 27No longer forecast to breakevenThe 3 analysts covering DURECT no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$41.2m in 2024. New consensus forecast suggests the company will make a loss of US$10.0m in 2024.
Board Change • Apr 27High number of new directorsIndependent Director Pete Garcia was the last director to join the board, commencing their role in 2021.
お知らせ • Apr 17DURECT Corporation, Annual General Meeting, Jun 15, 2022DURECT Corporation, Annual General Meeting, Jun 15, 2022, at 09:00 Pacific Standard Time. Agenda: To consider the electing of two Class I directors of its Board of Directors to serve until the 2025 annual meeting of stockholders; to approve an amendment to our Certificate of Incorporation to increase the number of authorized shares of our common stock from 350,000,000 to 600,000,000; to approve the amendment and restatement of the 2000 Stock Plan; to approve executive compensation; and to ratify the appointment of Ernst & Young LLP as the Company's independent registered public accounting firm for the current fiscal year.
Recent Insider Transactions • Mar 17Independent Director recently bought €107k worth of stockOn the 14th of March, Judith Robertson bought around 200k shares on-market at roughly €0.54 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €126k more in shares than they have sold in the last 12 months.
Breakeven Date Change • Mar 10No longer forecast to breakevenThe 3 analysts covering DURECT no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$41.2m in 2024. New consensus forecast suggests the company will make a loss of US$10.0m in 2024.
Reported Earnings • Mar 09Full year 2021 earnings: EPS in line with analyst expectations despite revenue beatFull year 2021 results: US$0.16 loss per share (down from US$0.072 loss in FY 2020). Revenue: US$14.0m (down 54% from FY 2020). Net loss: US$36.3m (loss widened 153% from FY 2020). Revenue exceeded analyst estimates by 59%. Over the next year, revenue is forecast to grow 9.7%, compared to a 8.2% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings.
お知らせ • Mar 06DURECT Corporation Announces Resignation of Michael Arenberg as Chief Financial Officer, Effective March 17, 2022On March 3, 2022, DURECT Corporation announced that Michael Arenberg will step down from his role as the Company’s Chief Financial Officer, effective March 17, 2022, to pursue another opportunity in an operating role. The Company has initiated a search to identify a new Chief Financial Officer. Matt Hogan, the Company’s former Chief Financial Officer from 2006-2018, who has continued to serve DURECT as a corporate finance advisor since 2018, will support the Company while the Company conducts its search for Mr. Arenberg’s replacement. Until a permanent replacement for Mr. Arenberg has been named, Jian Li will serve as the Company’s interim Principal Accounting Officer. Ms. Li has served as the Company’s Vice President, Finance and Corporate Controller since December 2003. She is also a certified public accountant and a member of the American Institute of Certified Public Accountants.
お知らせ • Mar 03Durect Corporation Doses First European Patient in Phase 2B Ahfirm Study of Larsucosterol(Dur-928) in Severe Alcohol-Associated HepatitisDURECT Corporation announced it dosed the first patient in the European Union as part of its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of larsucosterol in severe alcohol-associated hepatitis patients. Enrollment is ongoing in Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe acute alcohol-associated hepatitis to evaluate safety and efficacy of laRsucosterol treatMent. The study is comprised of three arms targeting enrollment of 300 total patients, with approximately 100 patients in each arm: Placebo plus standard of care which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician; larsucosterol; and larsucosterol . All patients in the trial receive supportive care. The primary outcome measure is 90-day survival rate for patients treated with larsucosterol compared to those treated with placebo plus SOC. The Company is targeting more than 60 clinical trial sites across the U.S., EU, U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration has granted larsucosterol Fast Track Designation for the treatment of AH. Believe demonstration of a robust survival benefit in the AHFIRM trial would support an NDA filing. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026. AH is a life-threatening acute alcohol-associated liver disease often caused by chronic heavy alcohol use and a recent period of increased alcohol consumption . It is characterized by severe inflammation and destruction of liver tissue, potentially leading to life-threatening complications, including liver failure, acute renal injury and multi-organ failure. There are no FDA approved therapies for AH and an analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median MELD score of 23.5, reported mortality at 28 and 90 days of 20% and 30.9% respectively. Stopping alcohol consumption is not sufficient for recovery in many moderate and severe patients and the use of treatments to reduce liver inflammation, such as corticosteroids, are limited by contraindications and have been shown to provide no survival benefit at 90 days or 1 year. While liver transplantation is becoming more common for alcoholic liver disease patients, including for AH patients, the procedure involves a long waiting period, a burdensome selection process and costs more than $875,000 on average.
お知らせ • Mar 01DURECT Corporation to Report Q4, 2021 Results on Mar 07, 2022DURECT Corporation announced that they will report Q4, 2021 results After-Market on Mar 07, 2022
Board Change • Jan 02High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Director Pete Garcia was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
Breakeven Date Change • Jan 01Forecast to breakeven in 2024The 3 analysts covering DURECT expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$41.2m in 2024. Average annual earnings growth of 65% is required to achieve expected profit on schedule.
Reported Earnings • Nov 04Third quarter 2021 earnings released: US$0.044 loss per share (vs US$0.046 loss in 3Q 2020)The company reported a poor third quarter result with increased losses, weaker revenues and weaker control over costs. Third quarter 2021 results: Revenue: US$2.17m (down 19% from 3Q 2020). Net loss: US$9.98m (loss widened 6.9% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has increased by 9% per year, which means it is tracking significantly ahead of earnings growth.
Reported Earnings • Jul 31Second quarter 2021 earnings released: US$0.04 loss per share (vs US$0.073 profit in 2Q 2020)The company reported a poor second quarter result with weaker earnings, revenues and control over costs. Second quarter 2021 results: Revenue: US$2.30m (down 91% from 2Q 2020). Net loss: US$9.15m (down 164% from profit in 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 3% per year and the company’s share price has also fallen by 3% per year.
Breakeven Date Change • Jun 25Forecast to breakeven in 2024The 4 analysts covering DURECT expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$36.8m in 2024. Average annual earnings growth of 73% is required to achieve expected profit on schedule.
お知らせ • Jun 24DURECT Corporation Presents Additional Clinical Data from DUR-928 Phase 1b Trial in NASH and Phase 1 Trial in Hepatic Impairment at the International Liver Conference 2021DURECT Corporation announced the presentation of additional clinical data from a DUR-928 Phase 1b trial in non-alcoholic steatohepatitis (NASH) and a Phase 1 trial in subjects with hepatic impairment (HI) as part of two posters at the 2021 International Liver Conference (EASL) being held virtually June 23-26, 2021. Poster #1198 entitled "Efficacy Signals of 4-Week Oral DUR-928 in NASH Subjects," presented by Eric Lawitz, M.D., Vice President, Scientific and Research Development, Texas Liver Institute, disclosed additional potential efficacy signals from DURECT's Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients. Key highlights include: Improvement from baseline in insulin resistance as assessed by the homeostatic model assessment (HOMA-IR). Subjects in the 50 mg and 150 mg groups had 22% and 18% median reductions (not statistically significant) of HOMA-IR from baseline respectively after 4 weeks of daily oral dosing of DUR-928. Subjects in the 600 mg group did not show a change in HOMA-IR. Improvement from baseline in liver stiffness, assessed by transient elastography (TE), magnetic resonance elastography (MRE) and the liver fibrosis marker pro-C3. Previously reported data showed improvement from baseline in: liver enzymes such as ALT, AST and GGT and improvements in serum lipid profiles such as LDL-C, non-HDLC and triglycerides; liver fat by MRI-PDFF imaging; and biomarkers of liver health, such as CK-18, a cell death biomarker, certain of which were statistically significant improvements. Safety profile: DUR-928 was safe and well tolerated by all subjects in the study. Data highlights from Poster #668 entitled "Safety and Pharmacokinetics of DUR-928 in Hepatic Function Impaired Subjects," presented by Jaymin Shah, Ph.D., Executive Director, Clinical Pharmacology and Pharmacokinetics at DURECT, included: Safety profile: DUR-928 was safe and well-tolerated by all moderate and severe hepatic impairment (HI) subjects with no adverse events and no dose-limiting toxicity reported throughout the study. Pharmacokinetics: As expected, clearance of DUR-928 was decreased in HI subjects compared to matched control subjects with normal hepatic function, leading to a 4-10 fold higher drug exposure (Cmax and AUC) in HI subjects depending on the severity of HI. Initial efficacy signals: A single oral dose of 200 mg of DUR-928 in subjects with HI resulted in statistically significant median reductions from baseline of the apoptosis biomarker M30 (cCK-18) at 12 hours post-dose.
お知らせ • Jun 10DURECT Corporation to Present Additional Clinical Data from DUR-928 Studies in NASH and in Hepatic Impairment At Upcoming International Liver Conference 2021DURECT Corporation announced it will present two posters at the 2021 International Liver Conference to be held virtually June 23-26, 2021. The first poster will discuss additional efficacy signals from a Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis patients. Previously reported data showed that DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day) with overall improvement from baseline observed in liver enzymes, serum lipid profiles, liver fat by imaging, and biomarkers of liver health. The poster will feature additional efficacy signal data including liver stiffness by transient elastography and magnetic resonance elastography, liver fibrosis marker, pro-C3, and ELF scores, as well as insulin resistance. A second poster will provide data from a Phase 1 study assessing the safety, tolerability, pharmacokinetics of DUR-928 in subjects with moderate and severe hepatic impairment, who received a single oral dose of 200mg DUR-928.
お知らせ • Mar 10Durect Corporation Announces Publication of Dur-928'S Mechanism of ActionDURECT Corporation announced the publication of a peer-reviewed research paper describing the binding sites and proposed mechanism of action of its lead drug candidate, an endogenous sulfated oxysterol and epigenetic regulator, DUR-928, in The Journal of Lipid Research. DUR-928 is an endogenous sulfated oxysterol that acts as an epigenetic regulator, a compound that regulates patterns of gene expression without modifying the DNA sequence. The publication shows that DUR-928 (referred to in the paper as 25HC3S) binds to and inhibits the activity of DNA methyltransferases (DNMTs), DNMT-1, 3a and 3b, epigenetic regulating enzymes that add methyl groups to DNA (a process called DNA methylation). As such, by inhibiting DNMT activity, DUR-928 inhibits DNA methylation, thereby regulating the expression of genes that modulate crucial cellular activities, including those associated with cell death, stress response, and lipid biosynthesis. These modulations may lead to improved cell survival, and reduced lipid accumulation and inflammation, as has been observed in various in vivo animal models and in results from DURECT's completed clinical trials in alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis (NASH). In a Phase 2a clinical trial in patients with AH, 100% of patients treated with DUR-928 survived the 28-day follow-up period compared to a 26% historical average 28-day mortality rate. 74% of patients treated with DUR-928 were discharged within 4 days or less of treatment after one dose. In a Phase 1b trial, patients with NASH treated with DUR-928 experienced significant improvements in biomarkers of liver function and liver health, including liver enzymes and serum lipid profiles. A reduction in liver fat of more than 10% was observed in 43% of these patients.
お知らせ • Feb 26DURECT Corporation to Report Q4, 2020 Results on Mar 04, 2021DURECT Corporation announced that they will report Q4, 2020 results After-Market on Mar 04, 2021
お知らせ • Feb 03DURECT Corporation Announces U.S. FDA Approval of POSIMIR® for Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial DecompressionDURECT Corporation announced that the U.S. Food and Drug Administration (FDA) has approved POSIMIR® (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opbioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01).
お知らせ • Jan 28DURECT Corporation Announces First Patient Dosed in Phase 2b AHFIRM Study of DUR-928 in Severe Alcohol-Associated HepatitisDURECT Corporation announced it has dosed the first patient in its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in severe alcohol-associated hepatitis (AH) patients. AHFIRM is a Phase 2b clinical trial evaluating the potential life-saving capacity of DUR-928 in patients with severe AH. AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores), and time in the intensive care unit. The Company is targeting 40-50 clinical trial sites in the US and Europe. Alcohol-Associated Hepatitis (also called Alcoholic Hepatitis or AH) is an acute form of alcohol-associated liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by recent onset jaundice and hepatic failure. According to the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 122,000 hospitalizations for patients with AH in 2017. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days after admission. DURECT's lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.
お知らせ • Jan 06DURECT Corporation Announces Board ChangesDURECT Corporation announced that the Board of Directors of DURECT has appointed, effective as of January 4, 2021 Ms. Gail Maderis as a Class I director of DURECT with a term to expire at the 2022 Annual Meeting of Stockholders and Dr. Mohammed Azab as a Class III director of DURECT with a term to expire at the 2021 Annual Meeting of Stockholders. In connection with the appointments, the Board approved an increase in the size of the Board, from eight to ten members, effective as of the Effective Date. Ms. Gail Maderis has served as the President, Chief Executive Officer and a board member of Antiva BioSciences Inc. Prior to that, Ms. Maderis served as the President and Chief Executive Officer of BayBio. Dr. Azab served as President and Chief Medical Officer of Astex Pharmaceuticals Inc. from January 2014 to November 2020, and prior to that, he had served as Astex’s Chief Medical Officer from July 2009 to January 2014.
お知らせ • Jan 05DURECT Corporation Announces Closing of LACTEL® Absorbable Polymer Product Line Sale to Evonik and Receipt of $15 MillionDURECT Corporation announced that the sale of the LACTEL product line to Evonik closed and the $15 million payment was received on December 31, 2020.
お知らせ • Dec 18DURECT Corporation Announces Dur-928 Granted Fda Fast Track Designation for Treatment of Alcoholic HepatitisDURECT Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to DUR-928 for the treatment of alcoholic hepatitis (AH, also known as alcohol-associated hepatitis). AH is an acute, life-threatening form of alcohol-associated liver disease (ALD). DUR-928 is the lead investigational product candidate in DURECT's Epigenetic Regulator program. The FDA grants Fast Track Designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track Designation can benefit from early and frequent communication with the agency in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.
お知らせ • Nov 14DURECT Corporation Announces Additional Safety Data and Efficacy Signals from Phase 1b Clinical Trial of DUR-928 in NASH Patients at The Liver Meeting Digital Experience 2020DURECT Corporation presented additional safety data and efficacy signals from its Phase 1b clinical trial of DUR-928 in nonalcoholic steatohepatitis (NASH) patients in a poster presentation at The AASLD Liver Meeting Digital Experience ™ (TLMdX) 2020. The study was a randomized, open label, multi center US study to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in NASH patients with stage 1-3 fibrosis. A total of 65 patients completed the study. DUR-928 was orally administered daily at 50 mg (n=23), 150 mg (n=21), or 600 mg (300 mg BID (n=21)). Patients in this trial were dosed daily for 4 weeks and followed up for an additional 4 weeks. DURECT's lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival. Nonalcoholic steatohepatitis (NASH) is the most severe and progressive form of nonalcoholic fatty liver disease (NAFLD) and the most common chronic liver disease worldwide, with an estimated prevalence of more than 10% of adults in the United States, Europe, Japan, and other developed countries, expected to double by 2030. No drug is currently approved for treatment of NAFLD or NASH.
お知らせ • Nov 11DURECT Corporation Appoints Norman Sussman as Chief Medical OfficerDURECT Corporation announced that Norman Sussman, MD, FAASLD, newly appointed Chief Medical Officer. Dr. Sussman will be available to answer questions following the formal presentations. Norman L. Sussman, MD, FAASLD, joined DURECT as Chief Medical Officer in November 2020. He has extensive clinical experience and expertise in the field of liver disease and brings over 30 years of clinical research and development experience in academia and industry. Prior to joining DURECT he was an Associate Professor of Medicine and Surgery at Baylor College of Medicine and a faculty member of Baylor College of Medicine intermittently since 1985. During that time, he served as a Principal Investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman gained leadership experience in industry as the founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix Inc. from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as Director of the telehealth program, Project ECHO®, at Baylor St. Luke's Medical Center.
お知らせ • Nov 03DURECT Corporation Appoints Norman Sussman as Chief Medical OfficerDURECT Corporation announced it has appointed Norman Sussman, M.D. as its Chief Medical Officer, effective immediately. In this new role, Dr. Sussman will oversee the clinical development of DURECT's pipeline including multiple indications for its lead investigational drug candidate DUR-928. Dr. Sussman has extensive clinical experience and expertise in the liver disease field and brings over 30 years of clinical research and development experience in academia and industry. He joins DURECT from Baylor College of Medicine, where he was an Associate Professor of Medicine and Surgery. Dr. Sussman has been a faculty member of Baylor College of Medicine intermittently since 1985. During this time, he has served as a Principal Investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman has also had leadership experience in industry as the founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix Inc. from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as Director of the telehealth program, Project ECHO®, at Baylor St. Luke's Medical Center.
お知らせ • Oct 28DURECT Corporation to Report Q3, 2020 Results on Nov 02, 2020DURECT Corporation announced that they will report Q3, 2020 results on Nov 02, 2020
お知らせ • Oct 06DURECT Corporation to Present Additional Safety and Efficacy Signals from Phase 1B Clinical Trial of Dur-928 in Nash Patients At the Liver Meeting Digital Experience 2020DURECT Corporation to present additional safety and efficacy signals from Phase 1B Clinical Trial of Dur-928 in Nash Patients At the Liver Meeting Digital Experience 2020. Topline results from the 4-week Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients were released previously, showing an overall improvement from baseline in liver enzymes, liver stiffness, and serum lipid profiles. At day 28, 43% of patients showed = 10% liver fat reduction from baseline as measured by magnetic resonance imaging - proton density fat fraction (MRI-PDFF). Daily oral dosing of DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day). Additional safety and efficacy data will be presented in the poster.
お知らせ • Sep 24DURECT Corporation Announces First Patient Dosed in Phase 2 Safety and Efficacy Study of DUR-928 in COVID-19 Patients with Acute Liver or Kidney InjuryDURECT Corporation announced it has dosed the first patient in its randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury. The primary efficacy endpoint is a composite of survival and being free of acute organ failure at Day 28. The company plans to enroll approximately 80 patients in multiple study sites across the U.S. This Phase 2, randomized, double-blind, placebo-controlled, multi-center study is designed to evaluate safety and efficacy of DUR-928 in COVID-19 patients with acute liver or kidney injury. A total of approximately 80 patients are planned to be enrolled into two study treatment groups in a 3:1 (DUR-928: placebo) ratio. Patients will receive a dose of 150 mg of DUR-928 or placebo by intravenous infusion on day 1 and day 4 in combination with standard of care therapy, which will be determined by the principal investigator (PI) at each clinical trial site. The primary efficacy endpoint is a composite of survival and being free of acute organ failure (free of mechanical ventilation, free of liver failure events and free of renal replacement therapy) at day 28. Patients will be followed for 60 days. Should any drug product be determined by the FDA to be safe and effective for the treatment of COVID-19 while the trial is ongoing, such treatments may be offered, at each PI's discretion, to any remaining and future patients in this trial.
お知らせ • Sep 23Durect Corporation Announces the Study Design for the Phase 2B Ahfirm Clinical Trial of DUR-928 in Severe Alcoholic Hepatitis (AH) PatientsDURECT Corporation announced the study design for the Phase 2b AHFIRM clinical trial of DUR-928 in severe alcoholic hepatitis (AH) patients. AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in the intensive care unit. The Company is targeting 40-45 clinical trial sites in the US and Europe and anticipates trial initiation in October. DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.
