Revance investors may receive additional information about the case by clicking the link "Submit Your Information" above. If you are a member of the class described below, you may no later than February 8, 2022 move the Court to serve as lead plaintiff of the class, if you so choose.
A class action lawsuit has been filed on behalf of those who purchased or acquired Revance Therapeutics, Inc. (“Revance”) (NASDAQ: RVNC) securities between November 25, 2019 and October 11, 2021, both dates inclusive (the “Class Period”).
Revance is a biotechnology company that engages in the development, manufacture, and commercialization of neuromodulators for various aesthetic and therapeutic indications in the United States and internationally. Revance’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. DAXI is in Phase II clinical trials to treat upper facial lines, moderate or severe dynamic forehead lines, and moderate or severe lateral canthal lines. DAXI has completed Phase II clinical trials for the treatment of adult upper limb spasticity and plantar fasciitis.
The Class Period commences on November 25, 2019, when 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”). Throughout the Class Period, the defendants touted Revance’s process for getting DAXI BLA approval.
The truth began to be revealed on October 12, 2021, when Revance issued a press release entitled, “Revance Continues to Anticipate FDA Approval of DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines in 2021.” In the press release, Revance responded to the public disclosure of the FDA’s Form 483. Among other things, the Form 483 indicated that “[t]he current manufacturing process is not the process proposed for licensure,” and “[t]he firm’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.” Following 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 entitled, “Revance Provides Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines.” In the press release, Revance disclosed that “[i]n a communication received on October 15, [2021,] 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.” Following 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 complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements and/or failed to disclose that: (1) quality control deficiencies existed at Revance’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 Revance had represented to investors; and (4) as a result, Revance’s public statements were materially false and misleading at all relevant times.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP: James Maro, Esq. (484) 270-1453; toll-free at (844) 887-9500; or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.