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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 Corporation (NASDAQ: DRRX) announced that Dr. James Brown, President and CEO, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, at 10:00 AM Eastern Time. The event is hosted by Ed Arce, Managing Director at H.C. Wainwright & Co. The session will cover DURECT's innovative therapies aimed at treating acute organ injury and chronic liver diseases, including the lead candidate Larsucosterol (DUR-928), which has received FDA Fast Track Designation for severe alcohol-associated hepatitis (SAH). A webcast of the chat will be available on DURECT's website, with a replay accessible for 90 days.
DURECT is focused on transforming treatments for liver diseases and has also licensed the FDA-approved POSIMIR for commercialization by Innocoll Pharmaceuticals in the United States.
DURECT Corporation (NASDAQ: DRRX) announced the acceptance of additional data from its Phase 2a trial evaluating larsucosterol for alcohol-associated hepatitis (AH), which will be published in the American Journal of Gastroenterology. The trial demonstrated a 100% survival rate among 19 patients during a 28-day follow-up, significantly better than the historical mortality rate of 26% in similar patients. The drug was well-tolerated across three doses and showed rapid improvements in liver biomarkers. Furthermore, the company is on track to report data from its ongoing Phase 2b AHFIRM trial in the second half of 2023, targeting 300 patients for further validation of larsucosterol's efficacy. With FDA Fast Track Designation, the company aims to expedite the drug's development to address an urgent medical need, as no FDA-approved therapies currently exist for AH.
DURECT Corporation (NASDAQ: DRRX) announced the appointment of Gail Maderis as the new Chair of the Board, effective March 17, 2023. She takes over from David Hoffmann, who will retire on June 21, 2023. Maderis has been a board member since January 2021, contributing to audit and compensation committees. The leadership change comes at a pivotal time for DURECT as it anticipates top-line data from its AHFIRM trial later this year. Maderis brings extensive biopharmaceutical experience, having previously led various organizations and currently serving as President and CEO of Antiva Biosciences.
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