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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 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.
DURECT Corporation (Nasdaq: DRRX) presented data at the AASLD Liver Meeting 2021, revealing a 19% increase in U.S. hospitalizations for alcohol-associated hepatitis (AH) from 2015 to 2018. The study highlighted that patients with AH face significant comorbidities and high healthcare costs, averaging $151,500 for fatalities compared to $56,000 for survivors. DURECT's drug candidate, larsucosterol (DUR-928), shows promise in treating AH, supported by encouraging Phase 2a trial results. The ongoing clinical trial AHFIRM aims to further assess its efficacy.
DURECT Corporation (Nasdaq: DRRX) has initiated dosing of the first ex-U.S. patient in Australia for its Phase 2b AHFIRM study, assessing larsucosterol's safety and efficacy in severe alcohol-associated hepatitis (AH). The study's primary goal is to evaluate the 90-day survival rate of patients receiving larsucosterol versus placebo plus standard care, involving over 300 patients across 60 clinical trial sites globally. With FDA's Fast Track Designation for larsucosterol in AH, the company aims to demonstrate significant benefits to support future NDA filings.
DURECT Corporation (Nasdaq: DRRX) announced that Dr. Suthat Liangpunsakul will present a poster at the AASLD The Liver Meeting® 2021, occurring virtually from November 12-15, 2021. The presentation will cover data regarding the prevalence, co-morbidities, and mortality of hospitalized alcohol-associated hepatitis (AH) patients in the U.S., utilizing data from 2015-2018. Following the conference, the e-poster will be accessible on the DURECT website under "DUR-928 Publications." DURECT is focused on innovative therapies for liver diseases, including its lead candidate, larsucosterol (DUR-928).
DURECT Corporation (Nasdaq: DRRX) reported Q3 2021 financial results with total revenues of $2.2 million, up from $1.8 million in Q3 2020, while net loss increased to $10.0 million compared to $9.3 million year-over-year. The company expanded its AHFIRM study sites to 60+, with 36 currently open, including its first international site in Australia. Licensing negotiations for POSIMIR are progressing, and the company expects to initiate ex-US dosing soon. As of September 30, 2021, cash and investments totaled $80.9 million.
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