Organogenesis Shares ReNu Program Update, On Track To Submit ReNu BLA By End Of 2025; Enrollment In Second Phase 3 Complete, Ahead Of Expectations

Organogenesis Holdings, Inc. Class A -3.03%

Organogenesis Holdings, Inc. Class A

ORGO

2.24

-3.03%

  • On track to submit ReNu BLA by the end of 2025

     
  • Enrollment in second Phase 3 complete; significantly ahead of expectations
  • Subgroup analysis demonstrated most severe (KL4) subjects responded comparably to moderate (KL3)

     

CANTON, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (NASDAQ:ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced a development program update for ReNu®, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA).

Organogenesis completed a Type-B meeting with the Food and Drug Administration (FDA) on July 25th. The FDA typically requires two well-controlled Phase 3 clinical trials to support regulatory approval. The FDA indicated that a second Phase 3 study would be needed to support BLA submission. Organogenesis recently completed enrollment in the second Phase 3 multi-center RCT evaluating the safety and efficacy of ReNu with 594 patients, significantly outperforming enrollment expectations. Based on the success of the first Phase 3 study and the completion of enrollment of the second study, Organogenesis expects to submit the BLA by the end of 2025.

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