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DURECT Corporation (DRRX) is a biopharmaceutical innovator advancing epigenetic treatments and drug delivery systems for complex conditions. This page provides investors and industry professionals with timely updates on clinical trials, regulatory milestones, and strategic developments.
Discover comprehensive coverage of DURECT's pipeline progress, including therapies targeting alcohol-associated hepatitis and pain management. Our curated news collection offers insights into FDA designations, partnership announcements, and research breakthroughs while maintaining strict editorial neutrality.
Key updates include late-stage clinical trial results, intellectual property developments, and analyses of therapeutic mechanisms. Bookmark this resource for streamlined access to verified information about DURECT's epigenetic modulation technologies and commercial strategies.
DURECT Corporation (Nasdaq: DRRX) announced a 1-for-10 reverse stock split effective December 5, 2022, aimed at meeting Nasdaq's minimum bid price requirement of $1.00. The decision follows stockholder approval during a Special Meeting held on November 22, 2022. Post-split, approximately 22.8 million shares will be outstanding, and the authorized shares will decrease from 600 million to 150 million. This reverse split is expected to attract more institutional investors while maintaining existing ownership percentages for shareholders.
DURECT Corporation (Nasdaq: DRRX) reported Q3 2022 revenues of $12.0 million with a net loss of $2.5 million, an improvement from $2.2 million in revenues and a net loss of $10 million during the same period in 2021. The company is optimistic about completing its AHFIRM trial enrollment by Q2 2023, ahead of schedule, as they have surpassed 200 patients enrolled. DURECT received $10 million in milestone payments related to the launch of POSIMIR by Innocoll and a new patent extending coverage until 2041.
DURECT Corporation (Nasdaq: DRRX) will report its third quarter 2022 financial results on November 2, 2022, at 4:30 PM ET, followed by a conference call. The company is focused on innovative therapies for acute organ injury and chronic liver diseases, with its lead candidate, larsucosterol (DUR-928), in development for conditions like alcohol-associated hepatitis, which has FDA Fast Track Designation. POSIMIR®, an FDA-approved non-opioid analgesic, is licensed to Innocoll Pharmaceuticals. Investors can access the conference details via a webcast.
DURECT Corporation (Nasdaq: DRRX) has surpassed 200 patient enrollments in its Phase 2b AHFIRM trial, aimed at evaluating larsucosterol for treating severe alcohol-associated hepatitis (AH). With a target of 300 patients, completion is anticipated by Q2 2023. The FDA has granted Fast Track Designation for larsucosterol, highlighting the urgent need for effective AH treatments. The trial's primary outcome will assess the 90-day incidence of mortality or liver transplantation, compared to placebo treatment. Topline results are expected in the second half of 2023.
POSIMIR®, a new treatment for post-surgical pain, is now available in the U.S. following its launch by Innocoll Pharmaceuticals in collaboration with DURECT Corporation (Nasdaq: DRRX). This FDA-approved, non-opioid sustained-release local analgesic is specifically designed for adults after arthroscopic subacromial decompression surgery. DURECT recently received milestone payments totaling $10 million for the patent issuance and first sale of POSIMIR, and stands to earn additional royalties and milestone payments of up to $122 million as sales progress.
DURECT Corporation (Nasdaq: DRRX) has announced that Dr. James E. Brown, President and CEO, will present at the H.C. Wainwright 24th annual Global Investment Conference on September 12, 2022. The presentation will be available on-demand starting at 7:00 am ET via the webcast link. Additionally, management will hold virtual one-on-one meetings from September 12-14, 2022. DURECT is focused on developing treatments for acute organ injury and chronic liver diseases, notably its lead candidate, Larsucosterol (DUR-928), which has received Fast Track Designation from the FDA.
DURECT Corporation (Nasdaq: DRRX) reported a net loss of $11.6 million for Q2 2022, on revenues of $2.1 million, slightly down from $2.3 million in Q2 2021. The company is advancing enrollment in its AHFIRM trial for larsucosterol (DUR-928), having reached 170 patients, with plans for 300 total. An FDA agreement allows the trial's primary endpoint to include liver transplantation alongside mortality. Additionally, a new patent for POSIMIR was issued, triggering an $8 million milestone payment.
DURECT Corporation (Nasdaq: DRRX) will report its financial results for Q2 2022 on August 4, 2022, at 4:30 PM ET. The call will also provide a business update, wherein the company is focused on advancing therapies for acute organ injury and chronic liver diseases, particularly with its lead drug candidate, larsucosterol (DUR-928), for alcohol-associated hepatitis (AH), with FDA Fast Track Designation. The drug is also being explored for non-alcoholic steatohepatitis (NASH).
DURECT Corporation (Nasdaq: DRRX) announced Timothy M. Papp as its new Chief Financial Officer on July 5, 2022. Papp brings over 25 years of corporate finance experience, including 15 years in biopharma, most recently from RBC Capital Markets. His role will encompass financial reporting, strategy, and investor relations. DURECT's lead candidate, larsucosterol, is in development for alcohol-associated hepatitis and has received FDA Fast Track Designation. The company also focuses on therapies for chronic liver diseases and has an FDA-approved product, POSIMIR, licensed to Innocoll Pharmaceuticals.
DURECT Corporation (Nasdaq: DRRX) will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on May 24, 2022, starting at 7:00 am Eastern Time. Key executives, including Dr. James E. Brown and Dr. Norman Sussman, will engage in the session hosted by Ed Arce. A webcast of the event will be available on DURECT's website. Additionally, from May 23-25, management will hold virtual 1x1 meetings. DURECT specializes in developing therapies for organ injury and chronic liver diseases, with its lead candidate, larsucosterol, in clinical trials for alcohol-associated hepatitis.