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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) 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.
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.
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