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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 (Nasdaq: DRRX) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. FDA granted Breakthrough Therapy Designation for larsucosterol in Alcohol-Associated Hepatitis (AH).
2. DURECT held a Type B meeting with FDA to discuss Phase 3 clinical trial design for larsucosterol in AH.
3. The company aims to initiate the Phase 3 trial in 2024, with topline results expected in 2H 2026, subject to sufficient funding.
4. Q2 2024 financial results: Total revenues were $2.2 million, net loss was $3.7 million. Cash, cash equivalents, and investments were $15.8 million as of June 30, 2024.
5. DURECT presented Phase 2b AHFIRM trial data at the EASL Congress 2024 in Milan, Italy.
DURECT (Nasdaq: DRRX), a late-stage biopharmaceutical company focused on epigenetic therapies, has announced it will release its second quarter 2024 financial results on Tuesday, August 13, 2024. The company will host a conference call and webcast at 4:30 pm Eastern Time to discuss the results and provide a corporate update. Investors can join via toll-free numbers or use the Call me™ link for instant access. A webcast will also be available. This event offers an opportunity for stakeholders to gain insights into DURECT's financial performance and future outlook in the field of acute organ injury and cancer treatments.
DURECT (Nasdaq: DRRX) has received Breakthrough Therapy designation (BTD) from the FDA for larsucosterol, aimed at treating severe alcohol-associated hepatitis (AH). AH has no approved treatments and high mortality rates, making the designation crucial. The decision is backed by positive results from the Phase 2b AHFIRM trial. DURECT plans to initiate a Phase 3 clinical trial to confirm the efficacy and safety of larsucosterol. Detailed results will be presented at the EASL Congress 2024 in Milan on June 8, 2024.
DURECT (Nasdaq: DRRX) announced its Q1 2024 financial results, showing $1.8 million in revenue and a net loss of $7.6 million, an improvement from the $12.0 million loss in Q1 2023. The company has $21.6 million in cash and investments, with a debt of $14.6 million as of March 31, 2024. The FDA's feedback supports a single pivotal Phase 3 trial for larsucosterol in alcohol-associated hepatitis (AH), with new Phase 3 protocol details expected later this year. DURECT will present Phase 2b AHFIRM trial data at the EASL Congress in June 2024. A webcast of the earnings call will be held today at 4:30 p.m. ET.
DURECT (Nasdaq: DRRX) will report its first quarter 2024 financial results on May 13, 2024. The company focuses on epigenetic therapies for severe conditions like organ injury and cancer. A conference call and webcast will follow to discuss the results and provide a corporate update.
DURECT (Nasdaq: DRRX) announced a late-breaking oral presentation at the EASL Congress 2024 to discuss data from the Phase 2b AHFIRM trial on larsucosterol for severe alcohol-associated hepatitis. The presentation will be held on June 8, 2024, in Milan, Italy.
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