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DURECT Corporation (Nasdaq: DRRX) is a specialized biopharmaceutical company focused on the research, development, and manufacturing of innovative pharmaceutical products. With expertise in drug discovery, delivery, and development, DURECT dedicates its efforts to creating therapies aimed at pain management, acute organ injury, and metabolic diseases. Their proprietary technologies, including oral, transdermal, and injectable depot delivery systems, enhance clinical and commercial attributes such as abuse deterrence, convenience, adherence, efficacy, and safety for both small molecule and biologic drugs.
One of DURECT’s key assets is larsucosterol, an epigenetic modulator currently in Phase 3 clinical trials for the treatment of severe alcohol-associated hepatitis (AH). This promising candidate has received both Fast Track and Breakthrough Therapy designations from the FDA. The company's Phase 2b AHFIRM trial demonstrated significant potential in reducing mortality among AH patients, paving the way for further research and development.
Another noteworthy product is POSIMIR®, an FDA-approved non-opioid analgesic for post-surgical pain management, which utilizes DURECT’s SABER® platform technology. It is exclusively licensed to Innocoll Pharmaceuticals for distribution in the United States.
DURECT also markets ALZET® osmotic pumps, widely used in preclinical research for continuous drug delivery in laboratory animals. A collaboration with Charles River Laboratories aims to further expand the reach of this product line within the pharmaceutical and academic sectors.
Financially, DURECT continues to advance its pipeline with strategic capital management, ensuring the sustainability of its operations while actively seeking regulatory approvals for its drug candidates. Their latest developments include quarterly financial reports, conference calls with stakeholders, and presentations at major medical conferences, showcasing their commitment to transparency and progress.
For more information, visit www.durect.com and follow the company on X (formerly Twitter) at https://x.com/DURECTCorp.
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.
DURECT (Nasdaq: DRRX) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. FDA granted Breakthrough Therapy Designation for larsucosterol in Alcohol-Associated Hepatitis (AH).
2. DURECT held a Type B meeting with FDA to discuss Phase 3 clinical trial design for larsucosterol in AH.
3. The company aims to initiate the Phase 3 trial in 2024, with topline results expected in 2H 2026, subject to sufficient funding.
4. Q2 2024 financial results: Total revenues were $2.2 million, net loss was $3.7 million. Cash, cash equivalents, and investments were $15.8 million as of June 30, 2024.
5. DURECT presented Phase 2b AHFIRM trial data at the EASL Congress 2024 in Milan, Italy.
DURECT (Nasdaq: DRRX), a late-stage biopharmaceutical company focused on epigenetic therapies, has announced it will release its second quarter 2024 financial results on Tuesday, August 13, 2024. The company will host a conference call and webcast at 4:30 pm Eastern Time to discuss the results and provide a corporate update. Investors can join via toll-free numbers or use the Call me™ link for instant access. A webcast will also be available. This event offers an opportunity for stakeholders to gain insights into DURECT's financial performance and future outlook in the field of acute organ injury and cancer treatments.
DURECT (Nasdaq: DRRX) has received Breakthrough Therapy designation (BTD) from the FDA for larsucosterol, aimed at treating severe alcohol-associated hepatitis (AH). AH has no approved treatments and high mortality rates, making the designation crucial. The decision is backed by positive results from the Phase 2b AHFIRM trial. DURECT plans to initiate a Phase 3 clinical trial to confirm the efficacy and safety of larsucosterol. Detailed results will be presented at the EASL Congress 2024 in Milan on June 8, 2024.
DURECT (Nasdaq: DRRX) announced its Q1 2024 financial results, showing $1.8 million in revenue and a net loss of $7.6 million, an improvement from the $12.0 million loss in Q1 2023. The company has $21.6 million in cash and investments, with a debt of $14.6 million as of March 31, 2024. The FDA's feedback supports a single pivotal Phase 3 trial for larsucosterol in alcohol-associated hepatitis (AH), with new Phase 3 protocol details expected later this year. DURECT will present Phase 2b AHFIRM trial data at the EASL Congress in June 2024. A webcast of the earnings call will be held today at 4:30 p.m. ET.
DURECT (Nasdaq: DRRX) will report its first quarter 2024 financial results on May 13, 2024. The company focuses on epigenetic therapies for severe conditions like organ injury and cancer. A conference call and webcast will follow to discuss the results and provide a corporate update.
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