9:48 AM
May 16, 2018
 |  BC Extra  |  Company News

FDA frowns on Evolus

Evolus Inc. (NASDAQ:EOLS) fell $3.95 (27%) to $10.70 on Wednesday after it said FDA issued a complete response letter for a BLA for prabotulinumtoxinA (DWP-450) to treat adults with glabellar lines (frown lines between the eyebrows). With the move, Evolus shed over $90 million in market cap.

Evolus said the CRL focused solely on CMC process deficiencies. It plans to respond to FDA "with a complete submission" within 90 days, and anticipates a spring 2019 launch for DWP-450.

The company has already responded to some of FDA's requests, and the agency's remaining questions are "manageable," Evolus President and CEO David Moatazedi said on a conference call Wednesday.

Separately, Evolus said FDA provided pre-approval to Daewoong Pharmaceutical Co. Ltd. (KSE:069620) for a DWP-450 manufacturing facility, which "puts a significant question mark around our manufacturing ability behind us," Moatazedi said.

EMA is reviewing an MAA for the injectable 900 kilodalton (kDa) botulinum toxin type A complex.

Evolus has mostly traded below its $12 IPO price since it went public in February. The company raised $60 million in the offering, which valued it at $283.1 million (see BioCentury Extra, Feb. 8).

Evolus is a subsidiary of Alphaeon Corp., which is majority-owned by Strathspey Crown Holdings LLC (Newport Beach, Calif.). Alphaeon owns 79% of Evolus.

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