Organogenesis Climbs on Clear FDA Path for Knee Osteoarthritis Drug
The regenerative medicine firm plans to file for approval of its ReNu therapy by the end of 2025, clarifying the regulatory path for a key asset targeting a multi-billion dollar market.
Shares of Organogenesis Holdings (NASDAQ: ORGO) rose in trading after the company announced it had secured a clear regulatory pathway with the U.S. Food and Drug Administration for its flagship knee osteoarthritis treatment, ReNu.
In a corporate announcement on Monday, the Canton, Massachusetts-based company disclosed the results of a successful Type-B meeting with the FDA. The discussion confirmed Organogenesis’s plan to submit a rolling Biologics License Application (BLA) for ReNu, with the process expected to begin by the end of December 2025. This clarification removes a significant layer of uncertainty for the product's journey to market.
The stock climbed to $4.83 following the news, reflecting investor optimism for a product targeting a substantial market. The company currently has a market capitalization of approximately $611 million.
"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... is appropriate for BLA submission. If approved, we believe that ReNu will address a significant medical need for a large and growing patient population."
The potential market is vast. Knee osteoarthritis is a debilitating condition affecting an estimated 31 million people in the U.S. and represents a significant cause of disability. The total market for knee osteoarthritis treatments is projected to reach over $13 billion in 2025, with non-surgical options currently commanding a majority of the market share.
ReNu, a cryopreserved amniotic suspension allograft, is designed as an injectable, non-surgical intervention. Its path to submission is supported by a comprehensive clinical program, including two Phase 3 randomized controlled trials. The journey has not been without complexity; the first Phase 3 trial met its primary endpoint by demonstrating a statistically significant reduction in knee pain at six months. However, a second Phase 3 study missed its primary pain-reduction endpoint but did show statistically significant improvements in patient function.
The FDA's acceptance of the BLA submission plan, despite the mixed trial results, is a significant vote of confidence. The product also holds a Regenerative Medicine Advanced Therapy (RMAT) designation, which can help expedite review.
Wall Street has been watching the ReNu program closely. The two analysts covering Organogenesis maintain a consensus "Buy" rating with a price target of $8.50, suggesting considerable upside from its current trading level. The company's stock has traded in a range of $2.61 to $7.08 over the past 52 weeks.
With a BLA submission timeline now set for late 2025, a potential FDA approval could realistically arrive in late 2026 or early 2027. An approval would position Organogenesis to compete in the lucrative non-surgical orthopedic market and establish a major new revenue stream beyond its current portfolio of wound care and surgical products.