Organogenesis shares rise 10.51% after-hours after initiating FDA BLA for ReNu knee arthritis treatment.

Organogenesis (NASDAQ:ORGO) surged 10.51% in after-hours trading following announcements of regulatory progress for its ReNu therapy targeting knee osteoarthritis. The company disclosed successful FDA meetings and initiated a rolling Biologics License Application (BLA) submission, with plans to complete the filing by year-end. These developments, highlighted in multiple December 15–24, 2025, reports, position ReNu closer to potential market approval, signaling therapeutic innovation and regulatory pathway clarity. While prior insider sales in late November 2025 briefly pressured shares, recent positive catalysts overshadowed short-term volatility, driving optimism around the product’s commercial prospects.