Ocugen, Inc. Announces FDA Alignment on Phase 2/3 Pivotal Confirmatory Clinical Trial for Modifier Gene Therapy Candidate OCU410ST for Stargardt Disease
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Ocugen, Inc. has received FDA alignment to proceed with a Phase 2/3 clinical trial for its gene therapy candidate OCU410ST, aimed at treating Stargardt Disease. A successful trial could lead to a biologics license application.
February 27, 2025 | 2:00 pm
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Ocugen has received FDA alignment to proceed with a Phase 2/3 trial for OCU410ST, a gene therapy for Stargardt Disease. A successful trial could lead to a BLA submission, potentially boosting Ocugen's market position.
The FDA's alignment on the Phase 2/3 trial is a significant regulatory milestone for Ocugen. If the trial is successful, it could lead to a BLA submission, potentially increasing Ocugen's market value and investor interest.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100