Revance Therapeutics, Inc.
Revance Therapeutics, Inc. (“Revance” or the “Company”), 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.
In November 2019, Revance issued a press release announcing that it had submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for DAXI to treat glabellar (frown) lines (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 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 control, review, and approval for outsourced activities[.]” Significantly, the Form 483 only came to light as a result of a Freedom of Information Act request directed to the FDA.
On this news, Revance’s stock price fell $6.85 per share, or 25%, to close at $20.45 per share on October 12, 2021.
Then, 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, Revance’s stock price fell $8.90 per share, or 39.19%, to close at $13.81 per share on October 18, 2021.
A securities class action has been filed against Revance on behalf of shareholders that purchased Revance shares between November 25, 2019 and October 11, 2021. This case has been filed in the U.S. District Court for the Northern District of California.
The complaint alleges that, 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.
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