BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Revance Therapeutics, Inc. (“Revance” or the “Company”) (NASDAQ: RVNC) investors concerning the Company’s possible violations of the federal securities laws.
In November 2019, Revance submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for its lead drug candidate, DaxibotulinumtoxinA (“DAXI”), for the treatment of glabellar lines.
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.
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 email@example.com, or visit our website at www.howardsmithlaw.com.
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