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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) 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.
DURECT Corporation (Nasdaq: DRRX) will report its fourth quarter and full year 2021 financial results on March 7, 2022, at 4:30 PM ET. The conference call will provide insights into the company’s financial performance and business developments, including updates on its lead drug candidate, Larsucosterol (DUR-928), which is in clinical trials for treating alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis (NASH). DURECT holds Fast Track Designation from the FDA for Larsucosterol, reflecting its potential in treating serious liver diseases.
DURECT Corporation (Nasdaq: DRRX) announced participation in the H.C. Wainwright Bioconnect Conference from January 10-13, 2022. Key executives—Dr. James E. Brown, Michael H. Arenberg, and Dr. Norman Sussman—will present on-demand starting at 7:00 A.M. EST on January 10. The webcast will be accessible via the company's website. DURECT is advancing innovative therapies for liver diseases, with its lead candidate, Larsucosterol (DUR-928), in clinical trials for alcohol-associated hepatitis and non-alcoholic steatohepatitis, holding an FDA Fast Track Designation.
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.
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