Revance Therapeutics, Inc.
|Company Name||Revance Therapeutics, Inc.|
|Class Period||November 25, 2019 to October 11, 2021|
|Lead Plaintiff Motion Deadline||February 08, 2022|
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.
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.
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