Revance Therapeutics is getting hammered today after the company flunked an inspection done by the U.S. Food and Drug Administration (FDA). 🔨
The regulator had a bone to pick with Revance’s working cell bank (WCB), which is required at the “later stages of therapeutic development and manufacturing,” according to BioReliance. The FDA said that Revance’s “Quality Unit lacks the responsibility and authority for the control, review, and approval of outsourced activities.“
That’s a big problem for Revance, which is commercializing a “next-generation version” of Botox called DaxibotulinumtoxinA. DaxibotulinumtoxinA has been called a possible treatment for frown lines, forehead lines, Crow’s feet, upper facial lines, Cervical Dystonia, Upper Limb Spasticity, and Plantar Fasciitis. In short: there’s a lot going for DaxibotulinumtoxinA. 👏 But this run-in with regulators goes to show that regulators can giveth and taketh away.
Inspections of company facilities are usually required before any treatment can be approved by the FDA. In Revance’s case, the company will likely need another inspection before securing the FDA’s green light for approval.
$RVNC stock fell over 20% today on the news.