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Pomerantz LLP announces that a class action lawsuit has been filed against Revance Therapeutics, Inc. and certain of its officers. The class action, filed in the United States District Court for the Northern District of California, and docketed under 21-cv-09585, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Revance securities between November 25, 2019 and October 11, 2021, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Revance securities during the Class Period, you have until February 8, 2022 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
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.
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”).
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.
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.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.
CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980
