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About DURECT Corporation (DRRX)
DURECT Corporation is a specialized biopharmaceutical company dedicated to advancing innovative therapeutic solutions that address serious and life-threatening conditions. With a robust expertise in drug discovery, drug delivery, and drug development, the company leverages its proprietary oral, transdermal, and injectable depot delivery technologies to enhance clinical and commercial outcomes. By focusing on improving attributes such as abuse deterrence, patient convenience, adherence, efficacy, and safety, DURECT is redefining therapeutic approaches in areas including pain management, acute organ injury, and metabolic diseases.
At the core of DURECT’s strategy is its pioneering development of epigenetic therapies. The company targets dysregulated DNA methylation—a key driver of aberrant gene expression and impaired cellular function—to modulate disease pathways. This is exemplified by its lead candidate under clinical investigation, which works by inhibiting DNA methyltransferases. Such an approach not only underscores the scientific rationale behind its therapeutic programs but also positions DURECT as a trailblazer in the emerging field of epigenomic regulation.
DURECT’s portfolio is characterized by a balanced integration of novel chemical entities and proprietary pharmaceutical programs. Its clinical pipeline includes late-stage studies that evaluate its innovative candidates in severe conditions, such as alcohol-associated hepatitis, where the limited therapeutic options underscore the critical need for effective treatments. The company’s efforts in this space are reinforced by strategic regulatory interactions, including Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration, which reflect confidence in its approach and clinical data.
In addition to its cutting-edge research and clinical development programs, DURECT has maintained a presence in the commercial market. It has marketed advanced drug delivery systems, such as osmotic pumps for research use, which have supported a wide range of scientific investigations. However, the company has strategically divested these non-core assets to focus its resources on high-impact clinical programs and epigenetic innovations. This realignment further illustrates DURECT’s dedication to addressing unmet medical needs through targeted and scientifically substantiated therapeutic developments.
Operating across key global markets including the United States, Europe, and Japan, DURECT is an integral part of the competitive biopharmaceutical landscape. Its commitment to rigorous clinical validation and sophisticated drug delivery methods sets it apart from its peers. By aligning laboratory science with clinical application, DURECT continues to drive forward a sophisticated portfolio of therapies aimed at transforming treatment paradigms in severe and complex diseases.
DURECT (DRRX) reported its Q4 and full year 2024 financial results, highlighting key developments in its larsucosterol program for alcohol-associated hepatitis (AH). The company's Phase 2b AHFIRM trial results were published in NEJM Evidence in January 2025, with additional data presented at The Liver Meeting 2024.
Financial highlights include: Q4 2024 revenue of $0.5M with net income of $7.8M, compared to Q4 2023 revenue of $0.9M and net loss of $1.4M. Full year 2024 showed revenue of $2.0M with a net loss of $7.9M, versus 2023 revenue of $2.6M and net loss of $27.6M. Cash position stood at $12.0M as of December 31, 2024.
The company sold its ALZET product line for $17.5M to Lafayette Instrument Co. and used the proceeds to repay its term loan with Oxford Finance DURECT is planning a Phase 3 trial for larsucosterol in severe AH, pending sufficient funding.
DURECT (DRRX), a late-stage biopharmaceutical company focused on epigenetic therapies targeting dysregulated DNA methylation, has scheduled its fourth quarter and full year 2024 financial results announcement for Wednesday, March 26, 2025.
The company will host a conference call and webcast with investors at 4:30 PM Eastern Time / 1:30 PM Pacific Time to discuss the financial results and provide a business update. Investors can access the event through guest dial-in numbers or use the Call me™ link for instant telephone access, which will be activated 15 minutes before the scheduled start time.
DURECT (DRRX) has announced its participation in the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference, scheduled for February 11-12, 2025. The company's President and CEO, James E. Brown, will deliver a presentation on Tuesday, February 11, from 2:00-2:30 PM ET on Track 5.
The conference will be held in a virtual format, and interested parties can access the presentation through a webcast link provided. Additionally, DURECT's management team will be available for one-on-one meetings with investors during the conference. Investors seeking to arrange meetings are advised to contact their Oppenheimer representative to schedule appointments.
DURECT (DRRX) has published Phase 2b AHFIRM trial results for larsucosterol in NEJM Evidence. The trial evaluated the drug's safety and efficacy in treating severe alcohol-associated hepatitis (AH) across 307 patients in three arms: placebo, 30mg, and 90mg doses.
The study showed clinically meaningful trends in reducing 90-day mortality, with 41% reduction in the 30mg arm (p=0.068) and 35% in the 90mg arm (p=0.124) compared to placebo. Results were more pronounced in U.S. patients, showing mortality reductions of 57% (p=0.014) and 58% (p=0.008) for 30mg and 90mg doses respectively.
The company plans to initiate a Phase 3 trial in 2025, pending funding. The FDA has indicated that a single Phase 3 trial could support a New Drug Application (NDA). The drug appeared safe and well-tolerated, with treatment emergent adverse events similar to placebo.
DURECT (DRRX) has sold its ALZET® osmotic pumps product line to Lafayette Instrument Co. for $17.5 million. The transaction includes certain assets and liabilities associated with the ALZET line. DURECT used the proceeds to pay off its remaining obligations under the Oxford Finance term loan. The company states this sale strengthens its cash position and extends runway through first half of 2025, allowing focus on developing larsucosterol for alcohol-associated hepatitis (AH) and its planned Phase 3 clinical trial.
DURECT (DRRX) reported Q3 2024 financial results with total revenues of $1.9 million and a net loss of $4.3 million. The company's cash position stood at $10.5 million as of September 30, 2024, down from $29.8 million at year-end 2023. DURECT is preparing for a Phase 3 trial of larsucosterol in severe alcohol-associated hepatitis, pending sufficient funding. The trial will focus on 90-day survival as the primary endpoint, with topline results expected within two years of initiation. Additionally, Innocoll Pharmaceuticals is terminating its POSIMIR® license agreement, effective May 2025.
DURECT (Nasdaq: DRRX), a late-stage biopharmaceutical company focused on epigenetic therapies, announced it will release its third quarter 2024 financial results on Wednesday, November 13, 2024. The company will host a conference call and webcast with investors at 4:30 pm Eastern Time to discuss financial results and provide a corporate update. Participants can join via toll-free number (1-877-407-0784), international number (1-201-689-8560), or through the Call Me™ link and webcast platform.
DURECT (Nasdaq: DRRX) will present data on larsucosterol at The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD), from November 15-19 in San Diego. The presentations will showcase additional data from DURECT's completed Phase 2b trial evaluating larsucosterol for the treatment of alcohol-associated hepatitis (AH).
The presentations include:
- An oral presentation on the effects of timely treatment on outcomes of larsucosterol for severe AH
- A poster on the ethical dilemmas of liver transplantation as an endpoint in AH trials
- A poster on drinking behavior in the AHFIRM trial as measured by Phosphatidyl Ethanol
These presentations will provide further support for the design of DURECT's upcoming Phase 3 trial of larsucosterol in AH, emphasizing the importance of timely treatment in clinical outcomes.
DURECT (Nasdaq: DRRX) has announced the design of its Phase 3 registrational trial for larsucosterol in treating alcohol-associated hepatitis (AH). Key points include:
- Agreement with FDA on trial design under Breakthrough Therapy designation
- Single Phase 3 trial to enroll 200 U.S. patients
- Primary endpoint: 90-day survival
- Topline results expected within two years of trial initiation
- Protocol builds on AHFIRM Phase 2b trial data, which showed 57% and 58% reduction in 90-day mortality for 30 mg and 90 mg doses, respectively, in U.S. patients
- FDA agreed that a single Phase 3 trial would support a New Drug Application (NDA)
- Larsucosterol's Breakthrough Therapy designation allows for rolling NDA submission
DURECT (DRRX), a late-stage biopharmaceutical company focused on epigenetic therapies for acute organ injury and cancer, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024 in New York City.
Key points:
- DURECT management will be present at the conference
- Virtual 1x1 meetings will be available during the conference dates
- Attendees can request meetings through H.C. Wainwright
This participation provides an opportunity for DURECT to showcase its innovative approach in developing treatments for serious and life-threatening conditions to potential investors and industry professionals.
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