View ValuationDURECT 향후 성장Future 기준 점검 0/6DURECT 의 수익과 수익은 각각 연간 31.4% 및 59.6% 감소할 것으로 예상됩니다 while EPS는 연간 27.7% 만큼 쇠퇴할 것으로 예상됩니다.핵심 정보-59.6%이익 성장률-27.71%EPS 성장률Pharmaceuticals 이익 성장26.3%매출 성장률-31.4%향후 자기자본이익률n/a애널리스트 커버리지Low마지막 업데이트30 Jul 2025최근 향후 성장 업데이트업데이트 없음모든 업데이트 보기Recent updates공지 • 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.공지 • Sep 13DURECT Corporation(NasdaqCM:DRRX) dropped from NASDAQ Composite IndexDURECT Corporation has been dropped from the NASDAQ Composite Index공지 • 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a majority of the outstanding shares of DURECT Corporation's common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions.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.공지 • 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.공지 • 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.공지 • 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, 2025공지 • 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”).공지 • 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.공지 • 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.공지 • Nov 07DURECT Corporation to Report Q3, 2024 Results on Nov 13, 2024DURECT Corporation announced that they will report Q3, 2024 results on Nov 13, 2024공지 • Aug 08DURECT Corporation to Report Q2, 2024 Results on Aug 13, 2024DURECT Corporation announced that they will report Q2, 2024 results on Aug 13, 2024공지 • Aug 05DURECT Corporation, Annual General Meeting, Sep 25, 2024DURECT Corporation, Annual General Meeting, Sep 25, 2024.공지 • 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, 2024공지 • Mar 21DURECT Corporation to Report Q4, 2023 Results on Mar 27, 2024DURECT Corporation announced that they will report Q4, 2023 results on Mar 27, 2024공지 • 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.공지 • Nov 10DURECT Corporation to Report Q3, 2023 Results on Nov 13, 2023DURECT Corporation announced that they will report Q3, 2023 results on Nov 13, 2023공지 • 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.공지 • 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.공지 • Aug 04DURECT Corporation to Report Q2, 2023 Results on Aug 09, 2023DURECT Corporation announced that they will report Q2, 2023 results on Aug 09, 2023공지 • 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.공지 • Oct 27DURECT Corporation to Report Q3, 2022 Results on Nov 02, 2022DURECT Corporation announced that they will report Q3, 2022 results at 4:30 PM, US Eastern Standard Time on Nov 02, 2022공지 • Oct 07DURECT Corporation Announces Enrollment of More Than 200 of Planned 300 Patients in is Phase 2b AHFIRM TrialDURECT Corporation announced the enrollment of more than 200 of the planned 300 patients in its Phase 2b AHFIRM trial. The AHFIRM trial seeks to evaluate larsucosterol's potential to serve as a treatment for severe alcohol-associated hepatitis (AH).공지 • Sep 27Innocoll Pharmaceuticals Limited and DURECT Corporation Announce U.S. Launch of POSIMIRInnocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, and DURECT Corporation announced the recent commercial launch of POSIMIR® (bupivacaine solution) in the United States. POSIMIR is an FDA-approved non-opioid, sustained-release local analgesic for the treatment of post-surgical pain in adults following arthroscopic subacromial decompression surgery. Per the terms of the collaboration between Innocoll and DURECT, Innocoll will make a $2 million payment to DURECT triggered by the first commercial sale of POSIMIR. Previously, in August 2022, DURECT was issued a new patent by the US Patent Office, extending US patent coverage of POSIMIR to at least 2041, resulting in an $8 million milestone payment by Innocoll to DURECT. These payments are in addition to the $4 million upfront license fee received in January 2022. As the launch progresses, DURECT will receive tiered, low double-digit to mid-teen royalties on net product sales in the United States, as well as additional milestone payments up to $122 million in the aggregate, depending on the achievement of certain commercial, regulatory and intellectual property milestone payments with respect to POSIMIR. In addition to the exclusive right to develop and commercialize POSIMIR in the United States, Innocoll also has been granted the right to conduct additional development activities to expand the approved indications for POSIMIR, and DURECT’s contract manufacturing supply agreement for POSIMIR has been assigned to Innocoll. DURECT retains all commercial rights to POSIMIR throughout the rest of the world. About POSIMIR: POSIMIR (bupivacaine solution) for infiltration use is a novel and proprietary product that combines the strength of 660 mg of bupivacaine base with the innovative SABER® platform technology, enabling continuous sustained delivery of a non-opioid local analgesic over 3 days in adults. POSIMIR contains more bupivacaine than any other approved single-dose sustained-release bupivacaine product. At the end of surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more. Indications and Usage: POSIMIR (bupivacaine solution) for infiltration use is indicated 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. Limitations of Use: Safety and effectiveness have not been established in other surgical procedures, including soft tissue surgical procedures, other orthopedic procedures, including for intra-articular administration, and boney procedures, or when used for neuraxial or peripheral nerve blockade.공지 • Aug 10DURECT Corporation Receives Approval from the Listing Qualifications Department of Nasdaq for an Additional 180-Day Grace Period, or Until February 6, 2023DURECT Corporation announced that as previously reported on a Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on February 11, 2022, the company received a letter (the "Notice") from The Nasdaq Stock Market ("Nasdaq") on February 9, 2022 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 August 8, 2022, to demonstrate its compliance with the Minimum Bid Price Requirement. On August 9, 2022, the Company received approval from the Listing Qualifications Department of Nasdaq for an additional 180-day grace period, or until February 6, 2023, 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 continued listing standards for 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 January 23, 2023, 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.Reported Earnings • Aug 05Second 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 8.0% 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 22% per year, which means it is performing significantly worse than earnings.공지 • Jul 28DURECT Corporation to Report Q2, 2022 Results on Aug 04, 2022DURECT Corporation announced that they will report Q2, 2022 results After-Market on Aug 04, 2022공지 • Jul 06DURECT Corporation Appoints Timothy M. Papp as Chief Financial OfficerDURECT Corporation announced the appointment of Timothy M. Papp as its Chief Financial Officer. In this new role, Mr. Papp will direct and oversee all financial and capital markets activities including accounting, financial reporting, financial planning and analysis, financial strategy, and investor relations. Mr. Papp brings over 25 years of corporate finance experience to DURECT, including 15 years in the Biopharma sector. He joins DURECT from RBC Capital Markets, where he was a Managing Director of Healthcare Investment Banking. Previously, he served as a Managing Director of Healthcare Investment Banking at Stifel, and he also served in Investment Banking and Mergers & Acquisitions roles at Cowen, Keybanc Capital Markets, and Rodman & Renshaw. Mr. Papp graduated cum laude from Duke University with a B.S. in Economics and earned an MBA from The Wharton School of Business with a concentration in Finance.이익 및 매출 성장 예측BST:DC8 - 애널리스트 향후 추정치 및 과거 재무 데이터 (USD Millions)날짜매출이익자유현금흐름영업현금흐름평균 애널리스트 수12/31/20261-33N/AN/A112/31/20251-21N/AN/A16/30/20252-13-14-14N/A3/31/20252-15-16-16N/A12/31/20242-18-19-19N/A9/30/20240-17-22-22N/A6/30/20240-16-26-26N/A3/31/20241-23-32-32N/A12/31/20233-28-34-34N/A9/30/20239-37-35-34N/A6/30/202319-36-29-29N/A3/31/202319-36-30-30N/A12/31/202219-35-26-26N/A9/30/202223-32-29-29N/A6/30/202213-39-34-34N/A3/31/202214-37-32-32N/A12/31/202114-36-38-37N/A9/30/20219-38-35-35N/A6/30/20219-37-36-36N/A3/31/202131-14-37-37N/A12/31/202030-14-39-39N/A9/30/202034-11-27-26N/A6/30/202043-311N/A3/31/202023-2444N/A12/31/201925-211111N/A9/30/201923-2411N/A6/30/201920-24-19-19N/A3/31/201919-24N/A-19N/A12/31/201815-25N/A-20N/A9/30/201834-10N/A-21N/A6/30/201835-1N/A-17N/A3/31/201836-4N/A1N/A12/31/201737-4N/A-1N/A9/30/201721-21N/A-1N/A6/30/201716-36N/A-10N/A3/31/201715-35N/A-30N/A12/31/201614-35N/A-27N/A9/30/201616-32N/A-26N/A6/30/201617-29N/A-25N/A3/31/201618-26N/A-22N/A12/31/201519-23N/A-21N/A9/30/201518-23N/A-17N/A6/30/201518-23N/A-17N/A3/31/201518-23N/A-17N/A12/31/201419-22N/A-15N/A9/30/201419-21N/A-15N/A더 보기애널리스트 향후 성장 전망수입 대 저축률: DC8 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 vs 시장: DC8 향후 3년 동안 수익성이 없을 것으로 예상됩니다.고성장 수익: DC8 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 대 시장: DC8 의 수익은 향후 3년간 감소할 것으로 예상됩니다(연간 -31.4%).고성장 매출: DC8 의 수익은 향후 3년 동안 감소할 것으로 예상됩니다(연간 -31.4%).주당순이익 성장 예측향후 자기자본이익률미래 ROE: DC8의 자본 수익률이 3년 후 높을 것으로 예상되는지 판단하기에 데이터가 부족합니다.성장 기업 찾아보기7D1Y7D1Y7D1YPharmaceuticals-biotech 산업의 고성장 기업.View Past Performance기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2025/09/11 19:35종가2025/07/29 00:00수익2025/06/30연간 수익2024/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스DURECT Corporation는 8명의 분석가가 다루고 있습니다. 이 중 1명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Mayank MamtaniB. Riley Securities, Inc.François BriseboisCraig-Hallum Capital Group LLCDavid WindleyJefferies LLC5명의 분석가 더 보기
공지 • 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.
공지 • Sep 13DURECT Corporation(NasdaqCM:DRRX) dropped from NASDAQ Composite IndexDURECT Corporation has been dropped from the NASDAQ Composite Index
공지 • 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.
공지 • 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.
공지 • 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.
공지 • 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
공지 • 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”).
공지 • 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.
공지 • 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.
공지 • 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
공지 • 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
공지 • Aug 05DURECT Corporation, Annual General Meeting, Sep 25, 2024DURECT Corporation, Annual General Meeting, Sep 25, 2024.
공지 • 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
공지 • 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
공지 • 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.
공지 • 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
공지 • 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.
공지 • 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.
공지 • 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
공지 • 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.
공지 • Oct 27DURECT Corporation to Report Q3, 2022 Results on Nov 02, 2022DURECT Corporation announced that they will report Q3, 2022 results at 4:30 PM, US Eastern Standard Time on Nov 02, 2022
공지 • Oct 07DURECT Corporation Announces Enrollment of More Than 200 of Planned 300 Patients in is Phase 2b AHFIRM TrialDURECT Corporation announced the enrollment of more than 200 of the planned 300 patients in its Phase 2b AHFIRM trial. The AHFIRM trial seeks to evaluate larsucosterol's potential to serve as a treatment for severe alcohol-associated hepatitis (AH).
공지 • Sep 27Innocoll Pharmaceuticals Limited and DURECT Corporation Announce U.S. Launch of POSIMIRInnocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, and DURECT Corporation announced the recent commercial launch of POSIMIR® (bupivacaine solution) in the United States. POSIMIR is an FDA-approved non-opioid, sustained-release local analgesic for the treatment of post-surgical pain in adults following arthroscopic subacromial decompression surgery. Per the terms of the collaboration between Innocoll and DURECT, Innocoll will make a $2 million payment to DURECT triggered by the first commercial sale of POSIMIR. Previously, in August 2022, DURECT was issued a new patent by the US Patent Office, extending US patent coverage of POSIMIR to at least 2041, resulting in an $8 million milestone payment by Innocoll to DURECT. These payments are in addition to the $4 million upfront license fee received in January 2022. As the launch progresses, DURECT will receive tiered, low double-digit to mid-teen royalties on net product sales in the United States, as well as additional milestone payments up to $122 million in the aggregate, depending on the achievement of certain commercial, regulatory and intellectual property milestone payments with respect to POSIMIR. In addition to the exclusive right to develop and commercialize POSIMIR in the United States, Innocoll also has been granted the right to conduct additional development activities to expand the approved indications for POSIMIR, and DURECT’s contract manufacturing supply agreement for POSIMIR has been assigned to Innocoll. DURECT retains all commercial rights to POSIMIR throughout the rest of the world. About POSIMIR: POSIMIR (bupivacaine solution) for infiltration use is a novel and proprietary product that combines the strength of 660 mg of bupivacaine base with the innovative SABER® platform technology, enabling continuous sustained delivery of a non-opioid local analgesic over 3 days in adults. POSIMIR contains more bupivacaine than any other approved single-dose sustained-release bupivacaine product. At the end of surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more. Indications and Usage: POSIMIR (bupivacaine solution) for infiltration use is indicated 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. Limitations of Use: Safety and effectiveness have not been established in other surgical procedures, including soft tissue surgical procedures, other orthopedic procedures, including for intra-articular administration, and boney procedures, or when used for neuraxial or peripheral nerve blockade.
공지 • Aug 10DURECT Corporation Receives Approval from the Listing Qualifications Department of Nasdaq for an Additional 180-Day Grace Period, or Until February 6, 2023DURECT Corporation announced that as previously reported on a Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on February 11, 2022, the company received a letter (the "Notice") from The Nasdaq Stock Market ("Nasdaq") on February 9, 2022 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 August 8, 2022, to demonstrate its compliance with the Minimum Bid Price Requirement. On August 9, 2022, the Company received approval from the Listing Qualifications Department of Nasdaq for an additional 180-day grace period, or until February 6, 2023, 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 continued listing standards for 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 January 23, 2023, 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.
Reported Earnings • Aug 05Second 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 8.0% 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 22% per year, which means it is performing significantly worse than earnings.
공지 • Jul 28DURECT Corporation to Report Q2, 2022 Results on Aug 04, 2022DURECT Corporation announced that they will report Q2, 2022 results After-Market on Aug 04, 2022
공지 • Jul 06DURECT Corporation Appoints Timothy M. Papp as Chief Financial OfficerDURECT Corporation announced the appointment of Timothy M. Papp as its Chief Financial Officer. In this new role, Mr. Papp will direct and oversee all financial and capital markets activities including accounting, financial reporting, financial planning and analysis, financial strategy, and investor relations. Mr. Papp brings over 25 years of corporate finance experience to DURECT, including 15 years in the Biopharma sector. He joins DURECT from RBC Capital Markets, where he was a Managing Director of Healthcare Investment Banking. Previously, he served as a Managing Director of Healthcare Investment Banking at Stifel, and he also served in Investment Banking and Mergers & Acquisitions roles at Cowen, Keybanc Capital Markets, and Rodman & Renshaw. Mr. Papp graduated cum laude from Duke University with a B.S. in Economics and earned an MBA from The Wharton School of Business with a concentration in Finance.