Organogenesis has reported a successful trial for its PuraPly AM product, demonstrating significant wound closure at 12 weeks. Additionally, the FDA has approved the rolling BLA for ReNu, further enhancing investor confidence and driving the stock up nearly 30% during premarket trading.
ReNu failed to achieve primary endpoint in the second Phase 3 trial. Baseline pain reduction slightly improved but lacks statistical significance. Company plans to meet with FDA for BLA pathway discussions. ReNu has a favorable safety profile despite trial outcomes. ORGO shares fell 15.49% to $3.95 following the announcement.