Revance Therapeutics, Inc. (RVNC) Misled Investors Regarding FDA Approval of its Lead Drug Candidate
A class action was filed on behalf of all persons and entities that purchased or otherwise acquired Revance Therapeutics, Inc. (NASDAQ: RVNC) securities between November 25, 2019 and October 11, 2021, for violations of the Securities Exchange Act of 1934. Revance is a biotechnology company that develops, manufactures, and commercializes neuromodulators for various aesthetic and therapeutic applications in the U.S. and internationally.
According to the complaint, Revance’s lead drug candidate is DaxibotulinumtoxinA for injection (“DAXI”), which has completed phase III clinical trials for the treatment of frown lines and cervical dystonia, and is in various stages of phase II trials for other uses. On November 25, 2019, Revance announced that it submitted a Biologics License Application (BLA) to the FDA for DAXI to treat frown lines. During the class period, defendants made false or misleading statements and failed to disclose that quality control deficiencies existed at the Company’s manufacturing facility for DAXI, which decreased the likelihood the FDA would approve the DAXI BLA.
On October 12, 2021, Revance disclosed that on July 2, 2021, the FDA had issued a Form 483 notifying Revance of serious issues the FDA had observed during its inspection of the Company’s Northern California DAXI manufacturing facility. On this news, Revance’s stock price fell 25%. Then, on October 15, 2021, Revance issued a press release announcing it had received a Complete Response Letter from the FDA and that the FDA was unable to approve the DAXI BLA due to the FDA’s onsite inspection at Revance’s manufacturing facility. On this news, Revance’s stock price fell almost 40% per share, to close at $13.81 per share on October 18, 2021.
If you acquired shares of Revance Therapeutics, Inc. (RVNC) securities between November 25, 2019 and October 11, 2021, you have until February 8, 2022, to ask the court to appoint you lead plaintiff for the class. Submit a form for more information.
Representation is on a contingency fee basis. Shareholders pay no fees or costs.