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Ocugen获得FDA批准开始OCU410ST的中期研究

2025-06-16 21:38

Ocugen (NASDAQ:OCGN) said on Monday that the U.S. FDA has cleared the company to initiate a phase 2/3 confirmatory trial of its modifier gene therapy, OCU410ST, to treat Stargardt disease, an eye disorder.
The FDA has already designated OCU410ST as a Rare Pediatric Disease and an Orphan Drug for treating specific retinal disorders linked to the ABCA4 gene, such as Stargardt disease and others.
Ocugen intends to file a marketing application for OCU410ST in 2027.
Stock is up 12.4% today.

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