OAKLAND, Calif.–(BUSINESS WIRE)–Shares of Revance Therapeutics, Inc. plummeted 39% on Monday, October 18, 2021 after it was disclosed that the FDA declined to approve its injection drug for face wrinkles, resulting in the third precipitous drop for the stock that week. The disclosure of the FDA’s decision came just days after the FDA posted Form 483 to its website, citing issues found during the inspection of a Revance facility in July 2021. Gibbs Law Group is investigating a potential Revance Securities Class Action Lawsuit on behalf of investors who lost money in Revance Therapeutics, Inc. (NASDAQ: RVNC).
To speak with an attorney regarding this class action lawsuit investigation, click here or call (888) 410-2925.
On October 12, 2021, the FDA responded to a Freedom of Information Act (FOIA) request and posted a heavily redacted Form 483 document from July 2021 outlining concerns with Revance’s manufacturing process for its wrinkle injection drug, as reported by the Morning Star. Shares of Revance subsequently tumbled more than 25%. Among other discrepancies, the Form noted that the Company’s quality unit “lacks the responsibility and authority for the control, review, and approval of outsourced activities…”
That same day, Revance issued an upbeat press release in response, insisting they continued to “anticipate FDA approval” of their drug and they “remain[ed] confident” in the quality of their application. Further, Revance characterized “the issuance of a Form 483 following the conclusion of an on-site inspection” as “not uncommon,” and stated the company had already given a response to the form in July.
Then just three days later on October 15, 2021, the FDA issued a complete response letter (CRL) declining to approve Revance’s wrinkle drug. According to Revance’s press release, the CRL cited “deficiencies related to the FDA’s onsite inspection at Revance’s manufacturing facility”—the same area of concern described by the Form 483 in July.
Following this news, Revance’s stock price dropped over 30% in after-hours trading on October 15, 2021, and plummeted an additional 39% on October 18, 2021, causing significant harm to investors.
What Should Revance Investors Do?
If you invested in Revance, visit our website or contact our securities team directly at (888) 410-2925 to discuss how you may be able to recover your losses. Our investigation concerns whether Revance has violated federal securities laws by providing false or misleading statements to investors.
About Gibbs Law Group
Gibbs Law Group represents investors throughout the country in securities litigation to correct abusive corporate governance practices, breaches of fiduciary duty, and proxy violations. The firm has recovered over a billion dollars for its clients against some of the world’s largest corporations, and our attorneys have received numerous honors for their work, including “Best Lawyers in America,” “Top Plaintiff Lawyers in California,” “California Lawyer Attorney of the Year,” “Class Action Practice Group of the Year,” “Consumer Protection MVP,” and “Top Women Lawyers in California.”
This press release may constitute Attorney Advertising in some jurisdictions under the applicable law and ethical rules.