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) 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.
DURECT Corporation (Nasdaq: DRRX) will report its Q3 2021 financial results on November 2, 2021, at 4:30 PM ET. A conference call will follow to discuss these results. The company is advancing its lead drug candidate, DUR-928, aimed at treating alcohol-associated hepatitis, currently in a Phase 2b clinical trial. The FDA has granted it Fast Track Designation. Additionally, DURECT's POSIMIR has received FDA approval. Investors should watch for performance metrics and further developments on the clinical trials during the upcoming call.
DURECT Corporation (Nasdaq: DRRX) announced participation in a fireside chat at the H.C. Wainwright 5th Annual NASH Investor Conference on October 12, 2021, from 2:30 PM to 3:00 PM EST. Key executives including CEO James E. Brown and CFO Michael H. Arenberg will present. The company's lead drug candidate, DUR-928, is in Phase 2b clinical trials for alcohol-associated hepatitis and has received FDA Fast Track Designation. POSIMIR, a non-opioid analgesic, is FDA-approved. Management will also hold virtual one-on-one meetings during the event.
DURECT Corporation (Nasdaq: DRRX) announced participation in a fireside chat at the Cantor Fitzgerald Global Healthcare Conference 2021, scheduled for September 28, 2021, from 2:40 P.M. to 3:10 P.M. EST. The discussion will feature key executives, including CEO James E. Brown and CFO Michael H. Arenberg. Investors can access the webcast through DURECT's website. The company focuses on developing therapies for acute organ injury and chronic liver diseases, with its lead candidate, DUR-928, currently in a Phase 2b trial for alcohol-associated hepatitis.
DURECT Corporation (Nasdaq: DRRX) announced participation in a fireside chat at Oppenheimer's Fall Healthcare Life Sciences & MedTech Summit on September 22, 2021. Key executives, including CEO James E. Brown and CFO Michael H. Arenberg, will engage in discussions highlighting the company’s strategies and clinical developments. The presentation will focus on DURECT's lead drug candidate, DUR-928, currently in a Phase 2b trial for alcohol-associated hepatitis, and its FDA-approved product, POSIMIR. The webcast can be accessed through DURECT's website, promoting transparency and investor engagement.
DURECT Corporation (Nasdaq: DRRX) announced participation in a fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021. Management, including CEO James E. Brown and CFO Michael H. Arenberg, will discuss the company’s progress and strategies. A recording will be available on-demand starting at 7:00 A.M. ET on the same day. DURECT is advancing its lead drug candidate, DUR-928, for alcohol-associated hepatitis, with FDA Fast Track Designation, while its POSIMIR product is FDA-approved.
DURECT Corporation (Nasdaq: DRRX) reported Q2 2021 total revenues of $2.3 million with a net loss of $9.1 million, down from $24.5 million revenue and a net income of $14.3 million in Q2 2020.
They expanded U.S. clinical sites for the Phase 2b AHFIRM study of DUR-928 for severe alcohol-associated hepatitis. Future sites are planned in the UK, Europe, and Australia. DUR-928 shows promise in treating liver conditions, with Fast Track Designation from the FDA. Additionally, POSIMIR received FDA approval for post-surgical analgesia. Cash and investments rose to $88.6 million as of June 30, 2021.
DURECT Corporation (Nasdaq: DRRX) will disclose its second-quarter 2021 financial results and host a conference call on July 29, 2021, at 4:30 PM ET. The company is developing DUR-928, which aims to treat alcohol-associated hepatitis and has received Fast Track Designation from the FDA. Currently, they are conducting a Phase 2b clinical trial named AHFIRM. Additionally, the company's POSIMIR product has gained FDA approval. DURECT also cautions about risks related to clinical trials and commercialization.
DURECT Corporation (Nasdaq: DRRX) will present at the Epigenetic Therapeutic Targets Summit on July 15, 2021, discussing its lead drug candidate DUR-928 for alcohol-associated hepatitis. CEO James E. Brown will highlight positive Phase 2a results and provide details on the ongoing Phase 2b study with 300 hospitalized patients. DUR-928 acts as an epigenetic regulator, targeting DNA methylation to potentially improve cell survival and reduce inflammation in liver diseases. The presentation will be available on DURECT's website post-conference.
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