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About DURECT Corporation (DRRX)
DURECT Corporation is a specialized biopharmaceutical company dedicated to advancing innovative therapeutic solutions that address serious and life-threatening conditions. With a robust expertise in drug discovery, drug delivery, and drug development, the company leverages its proprietary oral, transdermal, and injectable depot delivery technologies to enhance clinical and commercial outcomes. By focusing on improving attributes such as abuse deterrence, patient convenience, adherence, efficacy, and safety, DURECT is redefining therapeutic approaches in areas including pain management, acute organ injury, and metabolic diseases.
At the core of DURECT’s strategy is its pioneering development of epigenetic therapies. The company targets dysregulated DNA methylation—a key driver of aberrant gene expression and impaired cellular function—to modulate disease pathways. This is exemplified by its lead candidate under clinical investigation, which works by inhibiting DNA methyltransferases. Such an approach not only underscores the scientific rationale behind its therapeutic programs but also positions DURECT as a trailblazer in the emerging field of epigenomic regulation.
DURECT’s portfolio is characterized by a balanced integration of novel chemical entities and proprietary pharmaceutical programs. Its clinical pipeline includes late-stage studies that evaluate its innovative candidates in severe conditions, such as alcohol-associated hepatitis, where the limited therapeutic options underscore the critical need for effective treatments. The company’s efforts in this space are reinforced by strategic regulatory interactions, including Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration, which reflect confidence in its approach and clinical data.
In addition to its cutting-edge research and clinical development programs, DURECT has maintained a presence in the commercial market. It has marketed advanced drug delivery systems, such as osmotic pumps for research use, which have supported a wide range of scientific investigations. However, the company has strategically divested these non-core assets to focus its resources on high-impact clinical programs and epigenetic innovations. This realignment further illustrates DURECT’s dedication to addressing unmet medical needs through targeted and scientifically substantiated therapeutic developments.
Operating across key global markets including the United States, Europe, and Japan, DURECT is an integral part of the competitive biopharmaceutical landscape. Its commitment to rigorous clinical validation and sophisticated drug delivery methods sets it apart from its peers. By aligning laboratory science with clinical application, DURECT continues to drive forward a sophisticated portfolio of therapies aimed at transforming treatment paradigms in severe and complex diseases.
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.
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.
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