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Wednesday, Aug 17, 2022

FDA Sets Evolus Back

Irvine-based Evolus Inc.’s stock (Nasdaq: EOLS) have taken a rollercoaster ride this week. Shares earlier buoyed by news of its new chief executive dove today when it gave updates related to the regulatory progress on the pending approval of its drug candidate DWP-450.

Shares of the company traded at $10.70 per share, down $3.95 or 27% on the day, shaving $93 million off Evolus’ market value to $253 million.

Evolus shares before today had doubled since May 7, as traders discerned the drugmaker and the Food and Drug Administration were moving toward approval of DWP-450, a Botox rival.

Chief Executive David Moatazedi said in a conference call today the company now expects FDA approval in 2019. He joined Evolus last week; he was most recently senior vice president of Allergan plc’s U.S. medical aesthetics business that includes Botox.

Evolus’ drug candidate, licensed from pharmaceutical company Daewoong Pharmaceutical Co. Ltd., is said to function similarly to Botox. Its first indication is to treat frown lines.

FDA issued a Complete Response Letter to Evolus citing “deficiencies … to items related to Chemistry, Manufacturing and Controls processes,” a company press release said. “No deficiencies were related to clinical or non-clinical matters.”

Moatazedi declined to provide additional information but said Evolus is prepared to respond with a complete submission to FDA within 90 days.

He added the company successfully completed FDA inspection of Daewoong’s manufacturing facility in South Korea, which is Evolus’ plant.

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