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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) 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.
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.
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