NEW YORK, Oct. 19, 2021 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP is investigating potential claims against Revance Therapeutics, Inc. (“Revance” or the “Company”) (NASDAQ: RVNC). The investigation concerns whether Revance has violated the federal securities laws and/or engaged in other unlawful business practices.
Revance plans to compete in the Botulinum toxin market dominated by Allergan’s BOTOX. The Company bills its lead product candidate, DaxibotulinumtoxinA for Injection (“DAXI”), as the first long lasting botulinum toxin and is seeking DAXI’s U.S. Food and Drug Administration (“FDA”) approval for use in eyebrow frown lines.
As recently as August 5, 2021, Revance management claimed they “continue to anticipate approval” and that the FDA was following through with the expected inspection and therefore were advancing commercialization plans.
But, on October 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 the control, review, and approval of 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. On this news, the price of Revance shares declined by $6.85 per share, or approximately 25%, from $27.30 per share to close at $20.45 per share on October 12, 2021.
Then, on October 15, 2021, after the market closed, Revance reportedly received a Complete Response Letter from the FDA declining to approve the Company’s Biologics License Application for DAXI because of the manufacturing facility deficiencies previously outlined in the FDA’s July 2, 2021, Form 483. On this news, the price of Revance shares declined by $8.90 per share, or approximately 39.2%, from $22.71 per share to close at $13.81 per share on October 18, 2021.
If you purchased or otherwise acquired Revance securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at email@example.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.
Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website: http://www.kmllp.com.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.