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DURECT - DRRX STOCK NEWS

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 (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.

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DURECT Corporation (NASDAQ: DRRX) announced that Dr. James Brown, President and CEO, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, at 10:00 AM Eastern Time. The event is hosted by Ed Arce, Managing Director at H.C. Wainwright & Co. The session will cover DURECT's innovative therapies aimed at treating acute organ injury and chronic liver diseases, including the lead candidate Larsucosterol (DUR-928), which has received FDA Fast Track Designation for severe alcohol-associated hepatitis (SAH). A webcast of the chat will be available on DURECT's website, with a replay accessible for 90 days.

DURECT is focused on transforming treatments for liver diseases and has also licensed the FDA-approved POSIMIR for commercialization by Innocoll Pharmaceuticals in the United States.

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DURECT Corporation (NASDAQ: DRRX) announced the acceptance of additional data from its Phase 2a trial evaluating larsucosterol for alcohol-associated hepatitis (AH), which will be published in the American Journal of Gastroenterology. The trial demonstrated a 100% survival rate among 19 patients during a 28-day follow-up, significantly better than the historical mortality rate of 26% in similar patients. The drug was well-tolerated across three doses and showed rapid improvements in liver biomarkers. Furthermore, the company is on track to report data from its ongoing Phase 2b AHFIRM trial in the second half of 2023, targeting 300 patients for further validation of larsucosterol's efficacy. With FDA Fast Track Designation, the company aims to expedite the drug's development to address an urgent medical need, as no FDA-approved therapies currently exist for AH.

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DURECT Corporation (NASDAQ: DRRX) announced the appointment of Gail Maderis as the new Chair of the Board, effective March 17, 2023. She takes over from David Hoffmann, who will retire on June 21, 2023. Maderis has been a board member since January 2021, contributing to audit and compensation committees. The leadership change comes at a pivotal time for DURECT as it anticipates top-line data from its AHFIRM trial later this year. Maderis brings extensive biopharmaceutical experience, having previously led various organizations and currently serving as President and CEO of Antiva Biosciences.

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DURECT Corporation (Nasdaq: DRRX) announced that CEO Dr. James Brown and management will participate in a fireside chat at the Oppenheimer 33rd Annual Healthcare Conference on March 15, 2023. The discussion will be accessible from 2:00 to 2:20 PM Eastern Time and will cover DURECT's innovative therapies, including larsucosterol and POSIMIR. Larsucosterol is in clinical development for alcohol-associated hepatitis, with FDA Fast Track Designation. A webcast link for the presentation will be available on DURECT's website, with a replay available for 90 days. The press release includes forward-looking statements regarding future trials and commercialization efforts.

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DURECT Corporation (Nasdaq: DRRX) reported financial results for Q4 and FY 2022, with total revenues of $3.3 million for Q4, down from $7.3 million a year prior. The net loss increased to $10.5 million compared to $7.0 million in Q4 2021. For the full year, revenues were $19.3 million with a net loss of $35.3 million. Cash holdings decreased to $43.6 million from $70.0 million year-over-year. The company is on track to complete enrollment in the AHFIRM trial in Q2 2023, with topline data expected in the latter half of the year, which may allow for potential FDA discussions regarding a New Drug Application (NDA) for Larsucosterol.

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DURECT Corporation (NASDAQ: DRRX) has announced it will report its fourth quarter and full year 2022 financial results on March 7, 2023, after market closure. The company is set to host a conference call at 4:30 PM ET to discuss the results. DURECT is known for its advancements in treatment for acute organ injury and chronic liver diseases, particularly its lead drug candidate Larsucosterol (DUR-928), currently in clinical development for alcohol-associated hepatitis with FDA Fast Track Designation. The company also holds an FDA-approved product, POSIMIR, licensed to Innocoll Pharmaceuticals.

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DURECT Corporation (NASDAQ: DRRX) announced a registered direct offering of common stock and warrants, aiming to raise approximately $10 million. The offering includes 1,700,000 shares of common stock and pre-funded warrants for 300,000 shares, priced at $5.00 and $4.99999 respectively. Accompanying warrants will allow the purchase of up to 2,000,000 shares at $5.00 each, with pre-funded warrants having no expiration. The proceeds will be used for general corporate purposes, including clinical trials and research. Closing is expected on February 8, 2023, pending customary conditions.

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DURECT Corporation (Nasdaq: DRRX) announced a 1-for-10 reverse stock split effective December 5, 2022, aimed at meeting Nasdaq's minimum bid price requirement of $1.00. The decision follows stockholder approval during a Special Meeting held on November 22, 2022. Post-split, approximately 22.8 million shares will be outstanding, and the authorized shares will decrease from 600 million to 150 million. This reverse split is expected to attract more institutional investors while maintaining existing ownership percentages for shareholders.

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DURECT Corporation (Nasdaq: DRRX) reported Q3 2022 revenues of $12.0 million with a net loss of $2.5 million, an improvement from $2.2 million in revenues and a net loss of $10 million during the same period in 2021. The company is optimistic about completing its AHFIRM trial enrollment by Q2 2023, ahead of schedule, as they have surpassed 200 patients enrolled. DURECT received $10 million in milestone payments related to the launch of POSIMIR by Innocoll and a new patent extending coverage until 2041.

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DURECT Corporation (Nasdaq: DRRX) will report its third quarter 2022 financial results on November 2, 2022, at 4:30 PM ET, followed by a conference call. The company is focused on innovative therapies for acute organ injury and chronic liver diseases, with its lead candidate, larsucosterol (DUR-928), in development for conditions like alcohol-associated hepatitis, which has FDA Fast Track Designation. POSIMIR®, an FDA-approved non-opioid analgesic, is licensed to Innocoll Pharmaceuticals. Investors can access the conference details via a webcast.

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FAQ

What is the current stock price of DURECT (DRRX)?

The current stock price of DURECT (DRRX) is $0.7654 as of March 7, 2025.

What is the market cap of DURECT (DRRX)?

The market cap of DURECT (DRRX) is approximately 23.7M.

What is DURECT Corporation?

DURECT Corporation is a specialized biopharmaceutical company focused on the discovery, development, and manufacturing of innovative therapeutic solutions targeting serious and life-threatening conditions.

Which therapeutic areas does DURECT target?

The company focuses on a range of therapeutic areas including pain management, acute organ injury, metabolic diseases, and notably, conditions like alcohol-associated hepatitis through its epigenetic approaches.

How does DURECT differentiate its products?

DURECT leverages proprietary drug delivery technologies—spanning oral, transdermal, and injectable depot systems—to enhance attributes such as safety, efficacy, and patient adherence while reducing abuse potential.

What role do epigenetic therapies play in DURECT's pipeline?

Epigenetic therapies are central to DURECT’s strategy; they target dysregulated DNA methylation to modulate gene expression and cellular processes, which is key to addressing the underlying pathology of various severe diseases.

What clinical programs is the company currently advancing?

DURECT is advancing late-stage clinical programs, including studies on its lead epigenetic modulator for alcohol-associated hepatitis, supported by promising data from phase 2b trials and regulatory designations from the FDA.

How has DURECT realigned its business strategy?

The company has strategically divested non-core assets, such as its ALZET osmotic pumps, to concentrate its efforts and resources on its key clinical programs and epigenetic innovations.

In which regions does DURECT operate?

DURECT has a global footprint with operations in key markets including the United States, Europe, and Japan, positioning it well within the international biopharmaceutical sector.

How does DURECT maintain its competitive edge?

Through a strong focus on novel molecular mechanisms, advanced drug delivery systems, and proactive regulatory engagement, DURECT continues to innovate and address unmet medical needs in its therapeutic areas.
DURECT

Nasdaq:DRRX

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DRRX Stock Data

23.75M
27.67M
5.79%
23%
3.15%
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