Organogenesis to File BLA for ReNu After Positive FDA Meeting

Reuters12-16

Organogenesis to File BLA for ReNu After Positive FDA Meeting

Organogenesis Holdings Inc. announced the successful completion of a planned Type-B meeting with the FDA, confirming that its clinical development program for ReNu®-which includes two large Phase 3 randomized controlled trials, a separate 200-patient RCT, and extensive commercial history-is appropriate for a rolling Biologics License Application (BLA) submission. The company plans to submit the BLA for ReNu, intended for the treatment of knee osteoarthritis pain, by the end of 2025. The announcement did not specify if the research results have already been presented at scientific meetings or will be presented in the future.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Organogenesis Holdings Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9602576-en) on December 15, 2025, and is solely responsible for the information contained therein.

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