Organogenesis Holdings Inc shares surged 9.49% on Dec. 19 2025 after FDA clears BLA submission for ReNu therapy

Organogenesis Holdings Inc. shares surged 9.49% in pre-market trading on Dec. 19, 2025, driven by regulatory progress for its ReNu® therapy targeting knee osteoarthritis pain.

The biotechnology firm announced a successful meeting with the U.S. Food and Drug Administration, clearing the path to submit a Biologics License Application (BLA) for ReNu®. This milestone, disclosed on Nov. 6, 2025, marks a critical step toward potential commercialization of the treatment, reinforcing investor confidence in the company’s regulatory trajectory.

Separately, insider transactions drew attention as board member Glenn H. Nussdorf sold 200,000 shares of Class A Common Stock at $5.1353 apiece. Despite the large-scale sale, market optimism remained focused on the FDA-related developments. Nussdorf retains direct ownership of 2.57 million shares and indirect stakes through multiple trusts, signaling continued alignment with long-term value creation.

The stock’s performance highlights investor belief in Organogenesis’ potential to solidify its position in regenerative medicine. While corporate governance scrutiny persists, the BLA filing is seen as a pivotal catalyst for the company’s growth and market influence.