2 weeks Ago By By DURECT Corporation
CUPERTINO, Calif. , Nov. 6, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions, including acute organ injury, today announced that the company will report its third quarter financial results on Wednesday, November 13, 2024 .
Management will also host a conference call and webcast with investors to discuss financial results and provide a corporate update at 4:30 pm Eastern Time . Details for the call are as follows: Wednesday, November 13th @ 4:30 pm Eastern Time / 1:30 pm Pacific Time Toll Free: 1-877-407-0784 International: 1-201-689-8560 Call Me: https://callme.viavid.
com/viavid/?callme=true&passcode=13740526&h=true&info=company -email&r=true&B=6 Participants can use guest dial-in numbers above to reach an operator or they can click the Call me TM link for instant telephone access to the event (dial-out). The Call meTM link will be made active 15 minutes prior to the scheduled start time. Webcast: https://viavid.
webcasts.com/starthere.jsp?ei=1691806&tp_key=491002eb9b About DURECT Corporation DURECT is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury.
Larsucosterol, DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH is also being explored. In addition, POSIMIR ® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER ® platform technology, is FDA-approved and is exclusively licensed to Innocoll Pharmaceuticals for sale and distribution in the United States .
For more information about DURECT, please visit www.durect.com and follow us on X (formerly Twitter) at https://x.
com/DURECTCorp . DURECT Forward-Looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: our plans to report third quarter financial results on November 13, 2024 and the potential for larsucosterol to treat AH. Actual results may differ materially from those contained in the forward-looking statements contained in this press release, and reported results should not be considered as an indication of future performance.
The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risk that we do not raise sufficient capital to commence or complete the Phase 3 trial of larsucosterol in patients with AH or continue to fund our operations, the risk that future clinical trials of larsucosterol are delayed or do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterol in a statistically significant manner; the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for the treatment of AH, the risk that Breakthrough Therapy designation does not expedite the process for FDA approval and that larsucosterol may never be approved; and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our our ability to continue to meet the minimum bid price for continued listing on Nasdaq, and our ability to continue to operate as a going concern. Further information regarding these and other risks is included in DURECT's most recent Securities and Exchange Commission (SEC) filings, including its annual report on Form 10-K for the year ended December 31, 2023 , and quarterly report on Form 10-Q for the quarter ended September 30, 2024 , when filed, under the heading "Risk Factors." These reports are available on our website www.
durect.com under the "Investors" tab and on the SEC's website at www.sec.
gov . All information provided in this press release and in the attachments is based on information available to DURECT as of the date hereof, and DURECT assumes no obligation to update this information as a result of future events or developments, except as required by law. NOTE: POSIMIR ® is a trademark of Innocoll Pharmaceuticals, Ltd.
in the U.S. and a trademark of DURECT Corporation outside of the U.
S. SABER ® is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners.
Larsucosterol is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.
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