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DURECT Corporation (Nasdaq: DRRX) is a specialized biopharmaceutical company focused on the research, development, and manufacturing of innovative pharmaceutical products. With expertise in drug discovery, delivery, and development, DURECT dedicates its efforts to creating therapies aimed at pain management, acute organ injury, and metabolic diseases. Their proprietary technologies, including oral, transdermal, and injectable depot delivery systems, enhance clinical and commercial attributes such as abuse deterrence, convenience, adherence, efficacy, and safety for both small molecule and biologic drugs.
One of DURECT’s key assets is larsucosterol, an epigenetic modulator currently in Phase 3 clinical trials for the treatment of severe alcohol-associated hepatitis (AH). This promising candidate has received both Fast Track and Breakthrough Therapy designations from the FDA. The company's Phase 2b AHFIRM trial demonstrated significant potential in reducing mortality among AH patients, paving the way for further research and development.
Another noteworthy product is POSIMIR®, an FDA-approved non-opioid analgesic for post-surgical pain management, which utilizes DURECT’s SABER® platform technology. It is exclusively licensed to Innocoll Pharmaceuticals for distribution in the United States.
DURECT also markets ALZET® osmotic pumps, widely used in preclinical research for continuous drug delivery in laboratory animals. A collaboration with Charles River Laboratories aims to further expand the reach of this product line within the pharmaceutical and academic sectors.
Financially, DURECT continues to advance its pipeline with strategic capital management, ensuring the sustainability of its operations while actively seeking regulatory approvals for its drug candidates. Their latest developments include quarterly financial reports, conference calls with stakeholders, and presentations at major medical conferences, showcasing their commitment to transparency and progress.
For more information, visit www.durect.com and follow the company on X (formerly Twitter) at https://x.com/DURECTCorp.
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.
DURECT Corporation (Nasdaq: DRRX) announced the pricing of its public offering of 17,708,333 shares, aiming for gross proceeds of approximately $42.5 million. The offering, expected to close on February 8, 2021, includes a 30-day option for the underwriter to purchase an additional 2,656,249 shares. DURECT intends to utilize the proceeds for general corporate purposes, including clinical trials and research. The offering is structured under Form S-3, previously filed with the SEC. As of February 3, 2021, shares were priced at $2.87.
DURECT Corporation (Nasdaq: DRRX) announced an underwritten public offering of its common stock on February 3, 2021. The shares will be sold by DURECT, with the underwriter, Cantor Fitzgerald, obtaining a 30-day option to purchase an additional 15% of shares. This offering follows a "shelf" registration statement previously filed with the SEC. DURECT aims to advance its therapies for acute organ injury and chronic liver diseases, including its lead drug candidate, DUR-928, which is in clinical development for several indications.
DURECT Corporation (Nasdaq: DRRX) announced FDA approval for POSIMIR® (bupivacaine solution) to manage post-surgical pain in adults for up to 72 hours after arthroscopic subacromial decompression. The approval is based on a clinical trial showing a 20% reduction in pain intensity and a 67% decrease in opioid use compared to placebo. POSIMIR utilizes the innovative SABER® platform for sustained delivery, containing more bupivacaine than any other approved product. DURECT is seeking commercialization partners for POSIMIR, which holds potential to reduce opioid reliance.
DURECT Corporation (Nasdaq: DRRX) has initiated dosing in its Phase 2b AHFIRM study to evaluate DUR-928 in patients with severe alcohol-associated hepatitis (AH). This study aims to assess safety and efficacy compared to placebo and standard care, targeting 300 patients across multiple centers. Notably, DUR-928 showed promising results in a previous Phase 2a trial, where all 19 patients survived 28 days. The AHFIRM trial may support an NDA filing if a significant survival benefit is demonstrated.
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