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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) 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.
DURECT Corporation (Nasdaq: DRRX) presented pharmacokinetic data from a Phase 2a study of DUR-928 for alcoholic hepatitis at the Digital International Liver Congress 2020. The study included 19 patients and demonstrated that DUR-928 was well tolerated. Key findings revealed a 100% treatment response rate at lower doses and significant reductions in bilirubin and MELD scores at days 7 and 28. DURECT plans to initiate a Phase 2b trial later this year, focusing on survival rates in severe AH patients.
DURECT Corporation (Nasdaq: DRRX) announced participation in a fireside chat hosted by Cantor Fitzgerald on August 27, 2020, at 11:00 a.m. EDT. Key executives will present insights into the company's innovative therapies, particularly DUR-928, for treating acute organ injuries and chronic liver diseases, currently in various development phases. The live event will be accessible via webcast through the DURECT website. The firm remains focused on advancing its therapeutics amid the challenges posed by the ongoing COVID-19 pandemic.
DURECT Corporation (Nasdaq: DRRX) announced participation in the BTIG Biotechnology Conference 2020 on August 10, 2020, at 11:00 a.m. EDT. Key executives, including James E. Brown, Michael H. Arenberg, and Dr. WeiQi Lin, will engage in a fireside chat. Institutional investors can request virtual meetings through the conference coordinators. A live audio webcast will be available on their website. DURECT focuses on innovative therapies for liver diseases, with its lead candidate, DUR-928, currently in Phase 2 development for various conditions.
DURECT Corporation (Nasdaq: DRRX) reported a significant increase in financial performance for Q2 2020, with total revenues of $25.8 million and a net income of $14.3 million, compared to $4.0 million in revenues and a net loss of $7.2 million in Q2 2019. This revenue surge included a $23.1 million non-recurring deferred revenue from the termination of an agreement with Gilead. The company's cash and investments were $51.3 million as of June 30, 2020. DURECT continues to advance its clinical programs, notably DUR-928 in trials for NASH and COVID-19 patients.
DURECT Corporation (Nasdaq: DRRX) will announce its second quarter 2020 financial results on August 3, 2020, at 4:30 PM ET. The call will detail developments regarding their lead candidate DUR-928, aimed at treating alcoholic hepatitis and COVID-19-related liver injuries. DURECT emphasizes the innovation of its drug delivery technologies, including POSIMIR® for post-surgery pain relief. Forward-looking statements highlight potential risks, including clinical trial delays and the possibility of FDA non-approval for its products.
DURECT Corporation (Nasdaq: DRRX) has commenced patient recruitment for a Phase 2 clinical trial to assess the safety and efficacy of DUR-928 in COVID-19 patients suffering from acute liver or kidney injury. This randomized, double-blind, placebo-controlled study aims to enroll around 80 patients, focusing on survival and organ failure-free outcomes at Day 28. Previous positive results in acute hepatitis patients suggest DUR-928 may provide a treatment option for this high-risk group. The trial results will be closely monitored for regulatory implications.
DURECT Corporation (Nasdaq: DRRX) announced the termination of its License Agreement with Gilead Sciences, effective December 22, 2020. This decision affects the development of a long-acting injectable HIV product utilizing DURECT's SABER® technology. Following the termination, DURECT expects to recognize approximately $23.1 million in deferred revenue in Q2 2020, leading to net income for that quarter. However, the company faces potential risks related to its ongoing clinical trials for DUR-928 and regulatory approval for its product POSIMIR®, which are crucial for future growth.
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