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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) has entered into a licensing agreement with Innocoll Biotherapeutics for the exclusive U.S. development and commercialization of POSIMIR®, a non-opioid analgesic for post-surgical pain. The agreement includes a $6 million upfront payment, with potential additional payments totaling $130 million based on regulatory and commercial milestones. POSIMIR is set to launch in Q2 2022, aiming to address opioid alternatives in post-operative care. DURECT retains rights outside the U.S. and focuses on its lead drug, larsucosterol, for liver diseases.
DURECT Corporation (Nasdaq: DRRX) has expanded its board of directors with the appointment of Peter García, a seasoned expert in biopharmaceutical finance. García's over 25 years of leadership in the industry, including raising over $2 billion in capital, is expected to enhance DURECT's strategic direction as it advances its AHFIRM Phase 2b trial for larsucosterol, aimed at treating alcohol-associated hepatitis. CEO James E. Brown emphasized García’s experience will be crucial as DURECT transitions from development to the commercial stage. DURECT continues to focus on innovative treatments for acute organ injury and chronic liver diseases.
DURECT Corporation (Nasdaq: DRRX) announced participation in the 5th Annual NASH Summit workshop from November 29 to December 2, 2021. The session, led by President and CEO James E. Brown, will focus on the severe implications of alcoholic liver disease and the urgent need for effective treatments. This workshop aims to address morbidity and mortality factors associated with the disease. DURECT's drug candidate, Larsucosterol (DUR-928), is in clinical development for alcohol-associated hepatitis and has received Fast Track Designation from the FDA.
DURECT Corporation (Nasdaq: DRRX) presented data at the AASLD Liver Meeting 2021, revealing a 19% increase in U.S. hospitalizations for alcohol-associated hepatitis (AH) from 2015 to 2018. The study highlighted that patients with AH face significant comorbidities and high healthcare costs, averaging $151,500 for fatalities compared to $56,000 for survivors. DURECT's drug candidate, larsucosterol (DUR-928), shows promise in treating AH, supported by encouraging Phase 2a trial results. The ongoing clinical trial AHFIRM aims to further assess its efficacy.
DURECT Corporation (Nasdaq: DRRX) has initiated dosing of the first ex-U.S. patient in Australia for its Phase 2b AHFIRM study, assessing larsucosterol's safety and efficacy in severe alcohol-associated hepatitis (AH). The study's primary goal is to evaluate the 90-day survival rate of patients receiving larsucosterol versus placebo plus standard care, involving over 300 patients across 60 clinical trial sites globally. With FDA's Fast Track Designation for larsucosterol in AH, the company aims to demonstrate significant benefits to support future NDA filings.
DURECT Corporation (Nasdaq: DRRX) announced that Dr. Suthat Liangpunsakul will present a poster at the AASLD The Liver Meeting® 2021, occurring virtually from November 12-15, 2021. The presentation will cover data regarding the prevalence, co-morbidities, and mortality of hospitalized alcohol-associated hepatitis (AH) patients in the U.S., utilizing data from 2015-2018. Following the conference, the e-poster will be accessible on the DURECT website under "DUR-928 Publications." DURECT is focused on innovative therapies for liver diseases, including its lead candidate, larsucosterol (DUR-928).
DURECT Corporation (Nasdaq: DRRX) reported Q3 2021 financial results with total revenues of $2.2 million, up from $1.8 million in Q3 2020, while net loss increased to $10.0 million compared to $9.3 million year-over-year. The company expanded its AHFIRM study sites to 60+, with 36 currently open, including its first international site in Australia. Licensing negotiations for POSIMIR are progressing, and the company expects to initiate ex-US dosing soon. As of September 30, 2021, cash and investments totaled $80.9 million.
DURECT Corporation (Nasdaq: DRRX) will report its Q3 2021 financial results on November 2, 2021, at 4:30 PM ET. A conference call will follow to discuss these results. The company is advancing its lead drug candidate, DUR-928, aimed at treating alcohol-associated hepatitis, currently in a Phase 2b clinical trial. The FDA has granted it Fast Track Designation. Additionally, DURECT's POSIMIR has received FDA approval. Investors should watch for performance metrics and further developments on the clinical trials during the upcoming call.
DURECT Corporation (Nasdaq: DRRX) announced participation in a fireside chat at the H.C. Wainwright 5th Annual NASH Investor Conference on October 12, 2021, from 2:30 PM to 3:00 PM EST. Key executives including CEO James E. Brown and CFO Michael H. Arenberg will present. The company's lead drug candidate, DUR-928, is in Phase 2b clinical trials for alcohol-associated hepatitis and has received FDA Fast Track Designation. POSIMIR, a non-opioid analgesic, is FDA-approved. Management will also hold virtual one-on-one meetings during the event.
DURECT Corporation (Nasdaq: DRRX) announced participation in a fireside chat at the Cantor Fitzgerald Global Healthcare Conference 2021, scheduled for September 28, 2021, from 2:40 P.M. to 3:10 P.M. EST. The discussion will feature key executives, including CEO James E. Brown and CFO Michael H. Arenberg. Investors can access the webcast through DURECT's website. The company focuses on developing therapies for acute organ injury and chronic liver diseases, with its lead candidate, DUR-928, currently in a Phase 2b trial for alcohol-associated hepatitis.