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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 CEO Dr. James Brown and management will participate in a fireside chat at the Oppenheimer 33rd Annual Healthcare Conference on March 15, 2023. The discussion will be accessible from 2:00 to 2:20 PM Eastern Time and will cover DURECT's innovative therapies, including larsucosterol and POSIMIR. Larsucosterol is in clinical development for alcohol-associated hepatitis, with FDA Fast Track Designation. A webcast link for the presentation will be available on DURECT's website, with a replay available for 90 days. The press release includes forward-looking statements regarding future trials and commercialization efforts.
DURECT Corporation (Nasdaq: DRRX) reported financial results for Q4 and FY 2022, with total revenues of $3.3 million for Q4, down from $7.3 million a year prior. The net loss increased to $10.5 million compared to $7.0 million in Q4 2021. For the full year, revenues were $19.3 million with a net loss of $35.3 million. Cash holdings decreased to $43.6 million from $70.0 million year-over-year. The company is on track to complete enrollment in the AHFIRM trial in Q2 2023, with topline data expected in the latter half of the year, which may allow for potential FDA discussions regarding a New Drug Application (NDA) for Larsucosterol.
DURECT Corporation (NASDAQ: DRRX) has announced it will report its fourth quarter and full year 2022 financial results on March 7, 2023, after market closure. The company is set to host a conference call at 4:30 PM ET to discuss the results. DURECT is known for its advancements in treatment for acute organ injury and chronic liver diseases, particularly its lead drug candidate Larsucosterol (DUR-928), currently in clinical development for alcohol-associated hepatitis with FDA Fast Track Designation. The company also holds an FDA-approved product, POSIMIR, licensed to Innocoll Pharmaceuticals.
DURECT Corporation (NASDAQ: DRRX) announced a registered direct offering of common stock and warrants, aiming to raise approximately $10 million. The offering includes 1,700,000 shares of common stock and pre-funded warrants for 300,000 shares, priced at $5.00 and $4.99999 respectively. Accompanying warrants will allow the purchase of up to 2,000,000 shares at $5.00 each, with pre-funded warrants having no expiration. The proceeds will be used for general corporate purposes, including clinical trials and research. Closing is expected on February 8, 2023, pending customary conditions.
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.
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