Revance Therapeutics, Inc.

In the Revance securities case, Faruqi & Faruqi, LLP was appointed sole lead counsel. The lawsuit focuses on whether the Company and its executives violated federal securities laws by making materially false and misleading statements regarding Ideanomics’ business, operational and compliance policies.

Specifically, Defendants made false and/or misleading statements and/or failed to disclose 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.

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.

The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.

Documents:
0087-Revance-2024.05.01-SAC.pdf