Revance Therapeutics, Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Northern District of California on behalf of those who acquired Revance Therapeutics, Inc. (“Revance” or the “Company”) (NASDAQ: RVNC) securities from November 25, 2019 through October 11, 2021, inclusive (the “Class Period”). Investors have until February 8, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Revance, a biotechnology company, engages in the development, manufacture, and commercialization of neuromodulators for various aesthetic and therapeutic indications in the United States and internationally. The Company’s lead drug candidate is DaxibotulinumtoxinA for injection (“DAXI”), which has completed phase III clinical trials for the treatment of glabellar (frown) lines and cervical dystonia; is in phase II clinical trials to treat upper facial lines, moderate or severe dynamic forehead lines, and moderate or severe lateral canthal lines; and has completed Phase II clinical trials for the treatment of adult upper limb spasticity and plantar fasciitis.
On October 12, 2021, Revance disclosed that on July 2, 2021, the U.S. Food and Drug Administration (“FDA”) had issued a Form 483 notifying Revance of serious issues that the FDA had observed during its inspection of the Company’s Northern California DAXI manufacturing facility. Among other deficiencies, the FDA observed that “[t]he current manufacturing process is not the process proposed for licensure” and Revance’s “Quality Unit lacks the responsibility and authority for the control, review, and approval of outsourced activities[.]” Significantly, the Form 483 only came to light as a result of a Freedom of Information Act (FOIA) request directed to the FDA. On this news, the price of the Company’s shares declined by $6.85 per share, or approximately 25%, from $27.30 per share to close at $20.45 per share on October 12, 2021.
On October 15, 2021, Revance issued a press release announcing that it had received a Complete Response Letter (“CRL”) from the FDA, indicating that the FDA has determined “it is unable to approve the BLA in its present form and indicated that there are deficiencies related to the FDA’s onsite inspection at [Revance’s] manufacturing facility.” On this news, the price of the Company’s shares declined by $8.90 per share, or approximately 39.19%, from $22.71 per share to close at $13.81 per share on October 18, 2021.
The lawsuit alleges throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) quality control deficiencies existed at the Company’s manufacturing facility for DAXI; (ii) the foregoing deficiencies decreased the likelihood that the FDA would approve the DAXI BLA in its current form; (iii) accordingly, it was unlikely that the DAXI BLA would obtain FDA approval within the timeframe the Company had represented to investors; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.