Apellis gains as FDA says AdCom unnecessary for eye disease candidate

Sep. 07, 2022 3:07 PM ETApellis Pharmaceuticals, Inc. (APLS)ISEE, NGMBy: Dulan Lokuwithana, SA News Editor1 Comment

Headquarters of US Food and Drug Administration (FDA)


  • The commercial-stage biotech Apellis Pharmaceuticals (NASDAQ:APLS) added ~10% Wednesday amid comments attributed to its Chief Executive, who said that FDA would not conduct an AdCom meeting to decide on the marketing application for its lead asset pegcetacoplan.
  • The New Drug Application (NDA) for the intravitreal medication is currently under the FDA’s priority review as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with a target action date on Nov. 26.
  • At the Citi BioPharma Conference, APLS CEO Cedric Francois noted that the company concluded an FDA mid-cycle review for GA, during which the agency reiterated its plans not to hold an Advisory Committee meeting to decide on the NDA.
  • Other biotechs with candidates targeted at GA include NGM Biopharmaceuticals (NGM) and Iveric bio (ISEE), which shared Phase 3 data for its GA therapy Zimura on Tuesday.

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