Revance Shares Plunge On FDA Response Letter For Frown Line Candidate

·1 min read
  • The FDA has issued a Complete Response Letter (CRL) regarding Revance Therapeutics Inc's (NASDAQ: RVNC) marketing application for DaxibotulinumtoxinA for Injection for moderate to severe glabellar (frown) lines.

  • The agency indicated deficiencies related to the FDA's onsite inspection at Revance's manufacturing facility.

  • Revance plans to request a Type A meeting with the FDA to address the deficiencies raised. No other deficiencies were identified in the CRL.

  • "We are very disappointed by this unanticipated response from the FDA and are seeking further clarity from the agency. We remain committed to bringing our next-generation neuromodulator product to market in both aesthetic and therapeutic indications," said Mark Foley, President and CEO.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: RVNC shares are down 31.2% at $15.62 during the premarket session on the last check Monday.

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