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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 the pricing of its public offering of 17,708,333 shares, aiming for gross proceeds of approximately $42.5 million. The offering, expected to close on February 8, 2021, includes a 30-day option for the underwriter to purchase an additional 2,656,249 shares. DURECT intends to utilize the proceeds for general corporate purposes, including clinical trials and research. The offering is structured under Form S-3, previously filed with the SEC. As of February 3, 2021, shares were priced at $2.87.
DURECT Corporation (Nasdaq: DRRX) announced an underwritten public offering of its common stock on February 3, 2021. The shares will be sold by DURECT, with the underwriter, Cantor Fitzgerald, obtaining a 30-day option to purchase an additional 15% of shares. This offering follows a "shelf" registration statement previously filed with the SEC. DURECT aims to advance its therapies for acute organ injury and chronic liver diseases, including its lead drug candidate, DUR-928, which is in clinical development for several indications.
DURECT Corporation (Nasdaq: DRRX) announced FDA approval for POSIMIR® (bupivacaine solution) to manage post-surgical pain in adults for up to 72 hours after arthroscopic subacromial decompression. The approval is based on a clinical trial showing a 20% reduction in pain intensity and a 67% decrease in opioid use compared to placebo. POSIMIR utilizes the innovative SABER® platform for sustained delivery, containing more bupivacaine than any other approved product. DURECT is seeking commercialization partners for POSIMIR, which holds potential to reduce opioid reliance.
DURECT Corporation (Nasdaq: DRRX) has initiated dosing in its Phase 2b AHFIRM study to evaluate DUR-928 in patients with severe alcohol-associated hepatitis (AH). This study aims to assess safety and efficacy compared to placebo and standard care, targeting 300 patients across multiple centers. Notably, DUR-928 showed promising results in a previous Phase 2a trial, where all 19 patients survived 28 days. The AHFIRM trial may support an NDA filing if a significant survival benefit is demonstrated.
DURECT Corporation (Nasdaq: DRRX) has appointed Gail J. Maderis and Mohammad Azab to its board of directors, enhancing its board with industry veterans. Maderis brings extensive drug development experience, while Azab specializes in oncology. CEO James E. Brown highlighted their expertise as critical in advancing the clinical pipeline, particularly in the Phase 2b AHFIRM study of the lead candidate DUR-928 for alcohol-associated hepatitis. The company is focused on addressing significant unmet medical needs with DUR-928 and other potential therapies.
DURECT Corporation (Nasdaq: DRRX) announced the successful sale of its LACTEL product line to Evonik, with a total payment of $15 million received on December 31, 2020. This transaction marks a significant step in DURECT's strategic efforts to focus on its core biopharmaceutical operations. The company is advancing therapies targeting acute organ injuries and chronic liver diseases, notably through its lead candidate DUR-928, which is in clinical stages for various indications, including alcohol-associated hepatitis and COVID-19-related organ injuries.
DURECT Corporation (Nasdaq: DRRX) will participate in the H.C. Wainwright BioConnect 2021 Conference (January 11-14) and the LifeSci Advisors Corporate Access Event (January 6-8 and 11-14). Management will provide an on-demand corporate update starting January 11 at 6:00 am EST. Investors can register for virtual 1-on-1 meetings during both events. DURECT focuses on innovative therapies for acute organ injuries and chronic liver diseases, with DUR-928 in clinical development for alcohol-associated hepatitis and COVID-19-related injuries.
DURECT Corporation (Nasdaq: DRRX) has received Fast Track Designation from the FDA for its investigational drug DUR-928, aimed at treating alcoholic hepatitis (AH), a severe liver disease. This designation underscores the urgency for therapeutic options in this area. During a Phase 2a trial, DUR-928 showed a remarkable survival rate of 100% for patients at the 28-day follow-up, compared to a historical rate of 26%. DURECT plans to initiate a Phase 2b trial soon to expedite the development and potential approval of this promising treatment.
DURECT Corporation (Nasdaq: DRRX) announced a strategic agreement to sell its LACTEL Absorbable Polymer product line to Evonik for $15 million, with potential additional payments based on EBITDAS. The transaction is set to close by Q1 2021, pending customary conditions. This move allows DURECT to concentrate on developing DUR-928, aimed at treating alcohol-associated hepatitis and other liver diseases. Evonik will strengthen its healthcare solutions division through this acquisition, which aligns with its growth agenda in advanced drug delivery and biomaterials.
DURECT Corporation (Nasdaq: DRRX) presented promising results from its Phase 1b clinical trial of DUR-928 for nonalcoholic steatohepatitis (NASH) at The AASLD Liver Meeting Digital Experience 2020. Key findings include a significant reduction in cytokeratin-18 levels and improved biomarkers for liver health, particularly in patients with at least a 10% reduction in liver fat. DUR-928 demonstrated good tolerability across all doses and outperformed traditional metrics like liver enzymes and imaging. The study involved 65 patients completing a 4-week treatment regimen.
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