Shares of Revance Therapeutics Inc. (NAS:RVNC) plummeted 34.7% toward an 18-month low in premarket Monday, which puts them on track for a record one-day selloff, after the company said the the Food and Drug Administration issued a Complete Response Letter (CRL) regarding the biotechnology company's treatment of glabellar, or frown, lines. The company said late Friday that FDA determined it could not approve the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in its present form, citing deficiencies related to an inspection of Revance's manufacturing facility. The announcement comes after the company said late on Oct. 12, after Revance's stock plunged 25.1% that day, that it continued to expect the FDA to approve DaxibotulinumtoxinA for Injection this year. The stock, which is on track to open at the lowest price seen during regular-session hours since April 2020, has dropped 19.9% year to date through Friday, while the iShares Biotechnology ETF (NAS:IBB) has gained 3.7% and the S&P 500 (S&P:SPX) has rallied 19.0%.
Oct. 18, 2021, 8:32 a.m. EDT