Welcome to our dedicated page for DURECT news (Ticker: DRRX), a resource for investors and traders seeking the latest updates and insights on DURECT stock.
The DURECT Corporation (DRRX) news feed on Stock Titan aggregates historical company announcements, clinical updates, financial disclosures and transaction-related communications for this former Nasdaq-listed biopharmaceutical issuer. DURECT has described itself as a late-stage biopharmaceutical company focused on epigenetic therapies that target dysregulated DNA methylation, with particular emphasis on serious and life-threatening conditions such as alcohol-associated hepatitis (AH) and other forms of acute organ injury.
News items for DRRX include detailed updates on the development of the company’s lead investigational drug candidate, larsucosterol. These releases cover milestones such as the Phase 2b AHFIRM trial results, publication of data in NEJM Evidence, presentations at major liver disease meetings, and plans for a registrational Phase 3 trial in severe AH. Company communications also highlight that larsucosterol has received Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration for the treatment of AH.
The feed also captures DURECT’s corporate and portfolio developments, including announcements about its FDA-approved non-opioid analgesic POSIMIR, based on the SABER platform technology, and the sale of the ALZET osmotic pump product line. In 2025, a significant portion of the news flow relates to the tender offer and merger under which a subsidiary of Bausch Health Americas, Inc. agreed to acquire all outstanding shares of DURECT, followed by completion of the merger and subsequent delisting and deregistration of DRRX.
Investors and researchers can use this page to review historical earnings releases, business updates, clinical trial communications and acquisition-related announcements that together document DURECT’s evolution from a publicly traded company to an indirect wholly owned subsidiary within a larger pharmaceutical group.
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.
DURECT (Nasdaq: DRRX) announced a late-breaking oral presentation at the EASL Congress 2024 to discuss data from the Phase 2b AHFIRM trial on larsucosterol for severe alcohol-associated hepatitis. The presentation will be held on June 8, 2024, in Milan, Italy.
Summary not available.