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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) announced that Dr. Norman Sussman, the new Chief Medical Officer, will host a webinar on November 20, 2020, at 1:00 pm ET. The session will discuss the treatment of alcoholic hepatitis (AH) and DURECT's investigational drug, DUR-928, aimed at addressing this condition. DUR-928 is currently evaluated in the Phase 2b AHFRIM trial. This drug is designed to modulate critical gene expressions, enhancing cell survival and reducing inflammation. Following the presentation, Dr. Sussman will answer audience questions.
DURECT Corporation (Nasdaq: DRRX) reported Q3 2020 revenues of $2.7 million, down from $10.8 million in Q3 2019, with a net loss of $9.3 million compared to a loss of $2.0 million in the prior year. Cash and investments decreased to $49.8 million from $64.8 million at the end of 2019. The company is advancing the clinical trials for DUR-928, targeting conditions like Alcoholic Hepatitis, COVID-19, and NASH. The Phase 2b trial for Alcoholic Hepatitis will start dosing shortly, with potential implications for FDA approval.
DURECT Corporation (Nasdaq: DRRX) has appointed Dr. Norman Sussman as Chief Medical Officer, effective immediately. Dr. Sussman will guide the clinical development of the company's lead drug candidate, DUR-928, targeting conditions like alcoholic hepatitis (AH) and nonalcoholic steatohepatitis (NASH). With over 30 years in liver disease clinical research, his expertise is expected to enhance DURECT's efforts as it prepares for a pivotal Phase 2b trial in AH. The company aims to transform treatments for acute organ injury and chronic liver diseases with DUR-928, an innovative epigenetic regulator.
DURECT Corporation (Nasdaq: DRRX) will announce its third quarter 2020 financial results on November 2, 2020, at 4:30 PM ET. A conference call will follow, providing key updates on their clinical programs, including DUR-928, an investigational drug targeting acute organ injury and chronic liver diseases. DUR-928 is currently in Phase 2 trials for alcoholic hepatitis and COVID-19 related injuries, and Phase 1 for nonalcoholic steatohepatitis. The company is also advancing POSIMIR, a pain relief solution.
DURECT Corporation (Nasdaq: DRRX) will participate in the ROTH Capital Healthcare Event titled Covid-19 Therapeutics in Development on October 28, 2020. The webinar will cover various therapeutic sessions aimed at treating COVID-19. DURECT’s lead candidate, DUR-928, is in Phase 2 development for treating alcoholic hepatitis and COVID-19 patients with acute liver or kidney injury. Additionally, POSIMIR is being developed for post-surgery pain relief. The press release highlights potential risks in clinical development and FDA approval processes.
DURECT Corporation (Nasdaq: DRRX) announced its participation in the AASLD Liver Meeting Digital Experience 2020, presenting findings from its Phase 1b clinical trial of DUR-928 in nonalcoholic steatohepatitis (NASH) patients. Topline results indicated a 43% reduction in liver fat in patients, showing overall improvement in liver enzymes and lipid profiles. The study demonstrated safety across all dosing regimens. Further safety and efficacy data will be available during the meeting, enhancing understanding of DUR-928 as a potential treatment for liver diseases.
DURECT Corporation (Nasdaq: DRRX) announced participation in a fireside chat on October 5, 2020, from 2:30 p.m. to 3:00 p.m. EDT. Key executives, including President and CEO James E. Brown, CFO Michael H. Arenberg, and EVP of R&D Dr. WeiQi Lin, will join host Ed Arce from H. C. Wainwright. Investors can view the live webcast on DURECT's homepage under the 'Investors' tab or directly here. The company focuses on developing therapies for liver diseases and acute organ injury.
DURECT Corporation (Nasdaq: DRRX) has initiated a Phase 2 trial for DUR-928, targeting hospitalized COVID-19 patients suffering from acute liver or kidney injuries. This randomized, double-blind, placebo-controlled study aims to enroll around 80 patients, assessing safety and efficacy with a primary endpoint focused on survival and absence of organ failure by Day 28. Following promising results from prior trials on alcoholic hepatitis, DURECT is optimistic that DUR-928, combined with standard care, can aid these critical patients.
DURECT Corporation (NASDAQ: DRRX) announced the design of the Phase 2b AHFIRM clinical trial for its lead drug candidate, DUR-928, targeting severe alcoholic hepatitis (AH) patients. The trial will involve approximately 300 patients across three groups: two receiving different doses of DUR-928 and one placebo group. The primary outcome is the 90-day survival rate. Commencing in October, the study aims to validate promising Phase 2a results, with CEO James E. Brown emphasizing the urgent need for effective therapies in severe AH.
DURECT Corporation (Nasdaq: DRRX) will participate in several upcoming virtual investor conferences, including the HC Wainwright 22nd Annual Global Investment Conference on September 14, Cantor Fitzgerald Virtual Global Healthcare Conference on September 15, and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22. During these events, company representatives will engage in fireside chats discussing the company's advancements in treating acute organ injuries and chronic liver diseases, particularly their lead candidate, DUR-928.
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