Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Revance Therapeutics, Inc. (“Revance” or the “Company”) (NASDAQ: RVNC) securities between November 25, 2019 and October 11, 2021, inclusive (the “Class Period”). Revance investors have until February 8, 2022 to file a lead plaintiff motion.
Investors suffering losses on their Revance investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to howardsmith@howardsmithlaw.com.
On October 12, 2021, Revance stated that it “remains confident” in its BLA despite a Form 483 issued by the FDA following a recent inspection of the Company’s facility. The Form 483, which had been publicized pursuant to a Freedom of Information Act request, indicated that “[t]he current manufacturing process is not the process proposed for licensure.” The Form 483 also stated that Revance’s “Quality Unit lacks the responsibility and authority for the control, review, and approval of outsourced activities which includes defining the responsibilities and communication processes for quality-related activities in a written agreement.”
On this news, Revance’s stock fell $6.85, or 25%, to close at $20.45 per share on October 12, 2021, thereby injuring investors.
Then, on October 15, 2021, Revance disclosed receipt of a Complete Response Letter , which stated that the FDA “is unable to approve the BLA in its present form” due to “deficiencies related to the FDA’s onsite inspection of Revance’s manufacturing facility.”
On this news, Revance’s stock fell $8.90, or 39%, to close at $13.81 per share on October 18, 2021, thereby injuring investors further.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) quality control deficiencies existed at the Company’s manufacturing facility for DAXI; (2) the foregoing deficiencies decreased the likelihood that the FDA would approve the DAXI BLA in its current form; (3) accordingly, it was unlikely that the DAXI BLA would obtain FDA approval within the timeframe the Company had represented to investors; and (4) as a result, the Company’s public statements were materially false and misleading at all relevant times.
If you purchased Revance securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.
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