On Friday, October 15, 2021, Revance Therapeutics, Inc. (NASDAQ: RVNC) disclosed the FDA declined to approve its injection drug for face wrinkles. This disclosure came just days after the FDA posted a Form 483 to its website citing issues found during the inspection of a Revance facility in July 2021.
Shares of Revance plummeted 39% on Monday, October 18, 2021, causing significant harm to investors.
Revance shares tumble after FDA declines to approve its injection wrinkle drug
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. As a result, shares of Revance tumbled more than 25%. Among other discrepencies, 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.
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