Organogenesis Cleared to Begin Rolling BLA for ReNu Knee Osteoarthritis Therapy

Organogenesis (Nasdaq: ORGO) said it completed a Type B meeting with the FDA and received confirmation that the ReNu clinical development program is appropriate for a rolling Biologics License Application (BLA) submission expected by the end of 2025. The program includes two large Phase 3 randomized controlled trials, extensive commercial history, and RMAT designation.

The company plans to initiate a rolling BLA for ReNu before the end of December and said, if approved, ReNu could address knee osteoarthritis pain for millions of patients.

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