By Chris Wack


Apellis Pharmaceuticals Inc. shares were up 21% to $54 after the company said the U.S. Food and Drug Administration has accepted and granted priority-review designation for its new drug application for the eye-treatment pegcetacoplan.

The stock, which closed Monday's session down 3%, hit its 52-week high of $69.60 last July.

Pegcetacoplan is an investigational, targeted C3 therapy to treat geographic atrophy secondary to age-related macular degeneration.

The Prescription Drug User Fee Act target action date is Nov. 26. The FDA has stated that it isn't planning to hold an advisory committee meeting to discuss the application.

The NDA submission is based on studies showing treatment resulted in a clinically meaningful reduction of GA lesion growth across a broad, heterogeneous population of more than 1,500 patients. Pegcetacoplan demonstrated a favorable safety profile in all three studies.

Pegcetacoplan was previously granted fast-track designation by the FDA for the treatment of GA secondary to AMD.

Apellis plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

07-19-22 1315ET