Organogenesis second Phase 3 ReNu knee OA trial misses primary endpoint; pre-BLA meeting planned

Organogenesis Holdings Inc.

Second Phase 3 (n=594) did not meet primary endpoint: WOMAC pain reduction difference -0.5 favoring ReNu (p=0.0393 vs target p=0.023).
ReNu showed numerical improvement in baseline pain reduction vs first Phase 3 (-6.9 vs -6.0); safety profile favorable.
Statistically significant maintenance of function (p<0.0001) reported in second study.
Company to request pre-BLA meeting with FDA by end of October 2025 to discuss combined efficacy from both Phase 3 trials.
First Phase 3 met primary endpoint (difference -0.7, p=0.0177); ReNu has FDA RMAT designation.

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