Revance Therapeutics, Inc. (RVNC) Investigation:
Revance Therapeutics plans to compete in the Botulinum toxin market dominated by Allegan’s BOTOX. The company bills its lead product candidate DAXI as the first long lasting botulinum toxin and is seeking DAXI’s FDA approval for use in eyebrow frown lines.
The investigation focuses on Revance’s statements concerning the FDA’s pre-approval inspection of the company’s Northern California DAXI manufacturing facility and the timing and likelihood of FDA approval.
As recently as Aug. 5, 2021, Revance management claimed they felt “very good” that the FDA was following through with the expected inspection and therefore were advancing commercialization plans.
But, on Oct. 12, 2021, Revance revealed that on July 2, 2021, the FDA had issued a Form 483 informing Revance of serious issues it discovered during its inspection of the Northern California 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 (FOIA) request directed to the FDA.
This news sent the price of Revance shares crashing lower on Oct. 12, 2021.
“We’re focused on investors’ losses and whether Revance lied about the manufacturing of- and commercial prospects for- DAXI,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in Revance Therapeutics and have significant losses, or have knowledge that may assist the firm’s investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Persons with non-public information regarding Revance Therapeutics should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].
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Reed Kathrein, 844-916-0895
SOURCE Hagens Berman Sobol Shapiro LLP