Nov. 3 Quick Takes: FDA delay could shorten Apellis’ lead in geographic atrophy

FDA’s extended review of geographic atrophy candidate pegcetacoplan from Apellis Pharmaceuticals Inc. (NASDAQ:APLS) to review 24-month efficacy data from the Phase III DERBY and OAKS trials could shorten the biotech’s first-to-market advantage over competitor Iveric bio Inc. (NASDAQ:ISEE) if both companies’ therapies are approved. Apellis’ data submission constituted a major amendment to its NDA that required additional time to review, pushing pegcetacoplan’s PDUFA date to February 2023; the company’s shares traded 13% lower post-market after Apellis ended the day with a market cap of about $6.6 billion. The 24-month data suggest sustained efficacy at two years, though the C3 inhibitor missed DERBY’s 12-month primary endpoint while meeting OAKS’ primary endpoint. Iveric is preparing its own submission in 1Q23 of Zimura avacincaptad pegol.

NextCure Inc. (NASDAQ:NXTC) said that it is discontinuing development of NC318, a mAb targeting SIGLEC15 which was considered the next hot IO target at the 2019 Society for Immunotherapy of Cancer conference. NC318 failed to elicit any responses in a Phase II trial, the company said. ...