By Colin Kellaher
Shares of Revance Therapeutics Inc. tumbled in premarket trading Monday after the biotechnology company said the U.S. Food and Drug Administration had turned away its injection treatment for frown lines due to issues related to the drug's manufacturing plant.
The Newark, Calif., company late Friday said the FDA had issued a complete response letter, indicating that the agency wouldn't approve the application for DaxibotulinumtoxinA for Injection, or DAXI, in its current form.
Revance said the FDA indicated that it found deficiencies during its delayed inspection of its manufacturing plant in California, adding that the agency didn't identify any other issues.
Revance said it plans to request a meeting with the FDA as soon as possible to address the deficiencies, adding that it is "very disappointed by this unanticipated response."
Analysts at Mizuho said the latest development in the DAXI saga likely means a delay of about 12 to 15 months for approval of the drug.
The FDA in early 2020 had accepted Revance's application for DAXI, with a decision expected before the end of the year, but the agency later deferred its decision because it hadn't been able to inspect the manufacturing plant due to travel restrictions related to the Covid-19 pandemic. The FDA eventually conducted its pre-approval inspection in late June and early July of this year.
Revance shares fell sharply early last week after the FDA, responding to a Freedom of Information Act request, released a document outlining concerns raised by the inspection, but the stock rebounded Wednesday after Revance said it had already responded, and that it still expected FDA approval of DAXI by the end of this year.
Mizuho said it now assumes a late 2022 approval of the drug, with a launch in early 2023. The analysts cut their price target on Revance shares to $26 from $36 to reflect the delay, but they maintained their "buy" rating, saying they still expect DAXI will ultimately win FDA approval and represents a long-term opportunity.
Revance shares, which closed Friday at $22.71, were recently down nearly 32% to $15.47 in premarket trading.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires