Organogenesis announces successful FDA meeting, plans to file BLA for ReNu

Organogenesis (ORGO) announced the successful completion of a planned Type-B meeting with the FDA 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, COO of Organogenesis. “We are pleased the ReNu clinical development program consisting of two large Phase 3 randomized controlled trials, extensive commercial history and Regenerative Medicine Advanced Therapy-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.”