Iveric preps submission in ophthalmic indication, trailing Apellis at FDA

Iveric added about $740 million in market cap Tuesday after announcing new Phase III data that appear to give its C5 inhibitor a clear shot at FDA approval to treat geographic atrophy, potentially setting up the company to compete with a therapy from Apellis currently under the agency’s review.

Iveric bio Inc. (NASDAQ:ISEE) aims to submit an NDA in 1Q23 for Zimura avacincaptad pegol that will include new data from the GATHER2 study as well as results from GATHER1, a Phase II/III trial. Zimura met the primary endpoints in both studies to treat GA secondary to age-related macular degeneration...