Organogenesis Shares ReNu Program Update, On Track To Submit ReNu BLA By End Of 2025; Enrollment In Second Phase 3 Complete, Ahead Of Expectations
Portfolio Pulse from Benzinga Newsdesk
Organogenesis Holdings Inc. (NASDAQ: ORGO) announced that it is on track to submit the Biologics License Application (BLA) for its ReNu product by the end of 2025. The company has completed enrollment in the second Phase 3 clinical trial ahead of expectations, with 594 patients enrolled. The FDA has indicated that two well-controlled Phase 3 trials are required for regulatory approval.
August 08, 2024 | 9:13 pm
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Organogenesis Holdings Inc. (NASDAQ: ORGO) is on track to submit the BLA for ReNu by the end of 2025. The company completed enrollment in the second Phase 3 trial ahead of expectations, which is a positive indicator for future regulatory approval.
The completion of enrollment in the second Phase 3 trial ahead of expectations and the positive feedback from the FDA are strong indicators that Organogenesis is progressing well towards regulatory approval. This is likely to boost investor confidence and positively impact the stock price in the short term.
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