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)

Grandbrothers

  • 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.

Recommended For You

Comments (1)

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.