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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) 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.
DURECT Corporation (Nasdaq: DRRX) reported its Q1 2022 financial results with total revenues of $1.9 million and a net loss of $10.8 million. This reflects a decrease in revenue compared to $2.2 million in Q1 2021. The company is advancing in the AHFIRM trial for larsucosterol, with increased patient dosing and the opening of new clinical sites, now totaling 57 sites globally. DURECT has a partnership with Innocoll Pharmaceuticals for POSIMIR, expected to generate royalties and milestone payments. Cash and investments decreased to $64.4 million.
DURECT Corporation (Nasdaq: DRRX) will report its first quarter 2022 financial results after market close on May 4, 2022. The conference call will take place at 4:30 PM ET. DURECT is focused on developing innovative therapies for acute organ injury and chronic liver diseases. Its lead candidate, Larsucosterol (DUR-928), has received Fast Track Designation for alcohol-associated hepatitis (AH) and is also being explored for non-alcoholic steatohepatitis (NASH). Further information can be found at www.durect.com.
DURECT Corporation (Nasdaq: DRRX) announced that its President and CEO, Dr. James E. Brown, will participate in a panel titled "Small but Mighty: Innovative Strategies in Tackling Some of the Larger Rare Orphan Disease Markets" at the Cantor Virtual Rare Orphan Disease Summit on March 30, 2022, at 1:00 PM ET. The event will be hosted by Kristen Kluska of Cantor Fitzgerald. DURECT focuses on developing treatments for acute organ injury and chronic liver diseases, with its lead drug candidate, Larsucosterol (DUR-928), receiving Fast Track Designation from the FDA.
DURECT Corporation (Nasdaq: DRRX) will participate in a fireside chat at the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, from 1:20 PM - 1:50 PM EDT. Dr. James E. Brown, Dr. WeiQi Lin, and Dr. Norman Sussman will discuss the company’s progress in clinical development, focusing on their lead candidate, Larsucosterol (DUR-928), which targets alcohol-associated hepatitis and has received FDA Fast Track Designation. Additionally, the company’s non-opioid analgesic POSIMIR is licensed to Innocoll Pharmaceuticals for development in the U.S.
DURECT Corporation (Nasdaq: DRRX) reported its Q4 and full year 2021 financial results, highlighting total revenues of $7.3 million for the quarter and a net loss of $7.0 million, compared to $2.2 million and $8.8 million, respectively, in Q4 2020. Annual revenues decreased to $14.0 million from $30.1 million, with a net loss of $36.3 million. Progress in the AHFIRM trial includes over 100 patients dosed, and a licensing agreement for POSIMIR was signed with Innocoll, expected to generate up to $136 million. Cash and investments rose to $70.0 million.
DURECT Corporation (Nasdaq: DRRX) announced the dosing of its first patient in the EU for the Phase 2b AHFIRM study of larsucosterol in patients with severe alcohol-associated hepatitis (AH). This milestone marks progress in evaluating larsucosterol's efficacy and safety. The trial aims to enroll 300 patients across multiple regions, comparing larsucosterol with placebo and standard care. The FDA has granted Fast Track Designation for larsucosterol, emphasizing its potential to address a serious health issue. The primary outcome is the 90-day survival rate.
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