Ocugen, Inc. shares rise 7.17% premarket after FDA clearance for Phase 2/3 trial of OCU410ST.

Ocugen, Inc. rose 7.17% in premarket trading, following the announcement that the U.S. FDA has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.