Welcome to our dedicated page for DURECT news (Ticker: DRRX), a resource for investors and traders seeking the latest updates and insights on DURECT stock.
About DURECT Corporation
DURECT Corporation (Nasdaq: DRRX) is a late-stage biopharmaceutical company specializing in the development of innovative therapies targeting epigenetic mechanisms and advanced drug delivery technologies. Headquartered in Cupertino, California, DURECT is at the forefront of transforming the treatment landscape for serious and life-threatening conditions, including acute organ injury, alcohol-associated hepatitis (AH), and metabolic dysfunction-associated steatohepatitis (MASH).
Core Business Areas
DURECT’s expertise spans drug discovery, drug delivery, and drug development, with a focus on addressing unmet medical needs. The company leverages its proprietary oral, transdermal, and injectable depot delivery technologies to enhance therapeutic outcomes. These platforms enable improved drug efficacy, safety, convenience, and adherence, while also supporting novel indications for both small molecules and biologics.
Pipeline and Key Products
Larsucosterol, the company’s lead drug candidate, exemplifies its commitment to pioneering epigenetic therapies. Larsucosterol is an endogenous sulfated oxysterol that inhibits DNA methyltransferases (DNMTs), targeting dysregulated DNA methylation associated with severe alcohol-associated hepatitis (AH). This investigational therapy has received both Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA), underscoring its potential to address a condition with no currently approved treatments. DURECT is advancing larsucosterol into a pivotal Phase 3 clinical trial, with 90-day survival as the primary endpoint.
In addition to its pipeline, DURECT markets POSIMIR®, a non-opioid analgesic for infiltration use, which utilizes the company’s proprietary SABER® platform technology. POSIMIR® is FDA-approved and exclusively licensed to Innocoll Pharmaceuticals for distribution in the United States.
Proprietary Technologies
DURECT’s innovation extends to its proprietary drug delivery platforms, including the SABER® and ALZET® technologies. SABER® enables sustained drug release, enhancing the safety and efficacy of therapeutic agents. The ALZET® osmotic pump portfolio, recently divested to Lafayette Instrument Co., has been widely used in preclinical research, with over 22,000 scientific references highlighting its impact.
Market Position and Competitive Landscape
DURECT operates in the highly competitive biopharmaceutical sector, where differentiation is driven by innovation and regulatory success. Its focus on epigenetic modulation and late-stage clinical development positions it uniquely in addressing conditions like AH and MASH. The company’s collaborative approach, as evidenced by partnerships with entities like Innocoll Pharmaceuticals, further enhances its market reach and operational efficiency.
Challenges and Opportunities
While DURECT faces challenges such as regulatory approval processes and financial sustainability, its strategic prioritization of high-impact therapeutic areas and its robust intellectual property portfolio provide significant growth opportunities. The company’s ability to secure designations like Fast Track and Breakthrough Therapy for larsucosterol demonstrates its potential to bring transformative therapies to market.
Conclusion
DURECT Corporation exemplifies innovation in biopharmaceutical development, with a clear focus on addressing critical unmet medical needs. By leveraging its proprietary technologies and advancing its late-stage pipeline, DURECT is poised to make significant contributions to the treatment of severe and life-threatening conditions.
DURECT Corporation (Nasdaq: DRRX) will participate in a fireside chat at the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, from 1:20 PM - 1:50 PM EDT. Dr. James E. Brown, Dr. WeiQi Lin, and Dr. Norman Sussman will discuss the company’s progress in clinical development, focusing on their lead candidate, Larsucosterol (DUR-928), which targets alcohol-associated hepatitis and has received FDA Fast Track Designation. Additionally, the company’s non-opioid analgesic POSIMIR is licensed to Innocoll Pharmaceuticals for development in the U.S.
DURECT Corporation (Nasdaq: DRRX) reported its Q4 and full year 2021 financial results, highlighting total revenues of $7.3 million for the quarter and a net loss of $7.0 million, compared to $2.2 million and $8.8 million, respectively, in Q4 2020. Annual revenues decreased to $14.0 million from $30.1 million, with a net loss of $36.3 million. Progress in the AHFIRM trial includes over 100 patients dosed, and a licensing agreement for POSIMIR was signed with Innocoll, expected to generate up to $136 million. Cash and investments rose to $70.0 million.
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.
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