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About DURECT Corporation (DRRX)
DURECT Corporation is a specialized biopharmaceutical company dedicated to advancing innovative therapeutic solutions that address serious and life-threatening conditions. With a robust expertise in drug discovery, drug delivery, and drug development, the company leverages its proprietary oral, transdermal, and injectable depot delivery technologies to enhance clinical and commercial outcomes. By focusing on improving attributes such as abuse deterrence, patient convenience, adherence, efficacy, and safety, DURECT is redefining therapeutic approaches in areas including pain management, acute organ injury, and metabolic diseases.
At the core of DURECT’s strategy is its pioneering development of epigenetic therapies. The company targets dysregulated DNA methylation—a key driver of aberrant gene expression and impaired cellular function—to modulate disease pathways. This is exemplified by its lead candidate under clinical investigation, which works by inhibiting DNA methyltransferases. Such an approach not only underscores the scientific rationale behind its therapeutic programs but also positions DURECT as a trailblazer in the emerging field of epigenomic regulation.
DURECT’s portfolio is characterized by a balanced integration of novel chemical entities and proprietary pharmaceutical programs. Its clinical pipeline includes late-stage studies that evaluate its innovative candidates in severe conditions, such as alcohol-associated hepatitis, where the limited therapeutic options underscore the critical need for effective treatments. The company’s efforts in this space are reinforced by strategic regulatory interactions, including Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration, which reflect confidence in its approach and clinical data.
In addition to its cutting-edge research and clinical development programs, DURECT has maintained a presence in the commercial market. It has marketed advanced drug delivery systems, such as osmotic pumps for research use, which have supported a wide range of scientific investigations. However, the company has strategically divested these non-core assets to focus its resources on high-impact clinical programs and epigenetic innovations. This realignment further illustrates DURECT’s dedication to addressing unmet medical needs through targeted and scientifically substantiated therapeutic developments.
Operating across key global markets including the United States, Europe, and Japan, DURECT is an integral part of the competitive biopharmaceutical landscape. Its commitment to rigorous clinical validation and sophisticated drug delivery methods sets it apart from its peers. By aligning laboratory science with clinical application, DURECT continues to drive forward a sophisticated portfolio of therapies aimed at transforming treatment paradigms in severe and complex diseases.
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.
DURECT Corporation (Nasdaq: DRRX) presented new clinical data for DUR-928 at the 2021 International Liver Conference, showcasing potential efficacy in treating non-alcoholic steatohepatitis (NASH) and safety in subjects with hepatic impairment. The Phase 1b trial indicated a median 20% reduction in insulin resistance after 4 weeks of treatment. No adverse events were reported in the Phase 1 trial for hepatic impairment. DURECT is progressing with new trials and exploring additional applications for DUR-928.
DURECT Corporation (Nasdaq: DRRX) announced its participation at the International Liver Conference (EASL) from June 23-26, 2021, presenting two posters on DUR-928. The first poster highlights new efficacy signals from a Phase 1b study in nonalcoholic steatohepatitis (NASH) patients, showing improvements in liver health metrics. The second poster discusses a Phase 1 study on the safety and pharmacokinetics of DUR-928 in patients with varying hepatic impairments. Copies of the posters will be available on DURECT's website post-conference.
DURECT Corporation (DRRX) reported Q1 2021 financial results, achieving total revenues of $2.2 million and a net loss of $10.1 million, compared to $1.6 million and a net loss of $9.9 million in Q1 2020.
The company initiated patient dosing in the Phase 2b AHFIRM clinical study for DUR-928 in severe Alcohol-associated Hepatitis, while FDA approved POSIMIR for post-surgical analgesia. DURECT raised $47.8 million in equity, ending the quarter with $97.2 million in cash. Upcoming plans include discussions for POSIMIR commercialization and ongoing clinical trials.
DURECT Corporation (Nasdaq: DRRX) announced it will report its first quarter 2021 financial results on May 4, 2021, at 4:30 PM ET. The call will include a business update. The company is focused on developing innovative therapies for acute organ injuries and chronic liver diseases, notably its lead candidate DUR-928, which is currently in a Phase 2b trial for alcohol-associated hepatitis (AH). DURECT also has an FDA-approved product, POSIMIR, an analgesic solution. Risks associated with ongoing trials and commercialization efforts were highlighted in the release.
DURECT Corporation (Nasdaq: DRRX) published a peer-reviewed paper detailing the mechanism of action of its lead drug candidate, DUR-928, in The Journal of Lipid Research. DUR-928 acts as an epigenetic regulator, inhibiting DNA methyltransferases and regulating gene expression related to cellular activities. In clinical trials, DUR-928 demonstrated a 100% survival rate after 28 days in patients with alcohol-associated hepatitis (AH) and significant improvements in patients with non-alcoholic steatohepatitis (NASH). The company continues to advance ongoing clinical trials.
DURECT Corporation (Nasdaq: DRRX) reported Q4 2020 financial results, revealing total revenues of $2.2 million and net income of $4.4 million, compared to revenues of $9.0 million and a net loss of $4.2 million during Q4 2019. The company initiated the Phase 2b AHFIRM trial for DUR-928 in severe alcohol-associated hepatitis and received FDA Fast Track Designation. Notably, DURECT raised $47.8 million in equity and sold its LACTEL product line to Evonik for $15 million, enhancing its financial position. However, full-year revenues reached $30.1 million, slightly above the prior year's $25.1 million.
DURECT Corporation (Nasdaq: DRRX) announced its participation in three virtual investor conferences in March 2021. The events include:
- H.C. Wainwright Life Sciences Conference: Presentation on March 9, available on demand from 7:00 am (EST).
- ROTH Conference: Presentation on March 5, available on demand from 5:00 pm (EST).
- Oppenheimer & Co. Healthcare Conference: Presentation on March 17 at 11:20 am (EST).
Webcasts will be accessible via DURECT's website, where replays will also be available.
DURECT Corporation (Nasdaq: DRRX) will announce its fourth quarter and full year 2020 financial results on March 4, 2021, at 4:30 PM ET. The company will host a conference call following the announcement. DURECT is focused on innovative therapies to treat acute organ injury and chronic liver diseases, with lead drug candidate DUR-928 in clinical trials for alcohol-associated hepatitis and other conditions. POSIMIR, another product, is FDA-approved for non-opioid pain management. The firm emphasizes ongoing developments in light of economic uncertainties.
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