Organogenesis plans to file BLA for ReNu before end of December

Organogenesis (ORGO) Holdings announced the successful completion of a planned Type-B meeting with the Food and Drug Administration resulting in confirmation to initiate a rolling Biologics Licenses Application for ReNu planned before the end of December. We are excited about the outcome of our FDA meeting and reaching this important milestone in the ReNu program,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are pleased the ReNu clinical development program consisting of two large Phase 3 randomized controlled trials (RCT), a separate 200-patient RCT, extensive commercial history and Regenerative Medicine Advanced Therapy (RMAT)-designation is appropriate for BLA submission. If approved, we believe that ReNu will address a significant medical need for a large and growing patient population.”