Levi & Korsinsky notifies investors that it has commenced an investigation into Organogenesis Holdings Inc. (NASDAQ: ORGO) concerning potential violations of the federal securities laws.
Organogenesis issued a press release on September 25, 2025, disclosing that a second phase 3 trial of its cryopreserved amniotic suspension allograft ReNu missed its primary endpoint, having failed to achieve a significantly significant change in pain reduction. The Company said it would ask for a pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration by the end of October to examine a submission pathway, "including using the combined efficacy analysis from both Phase 3 studies to support a BLA approval," according to Chief Operating Officer Patrick Bilbo. Following this news, Organogenesis's stock price fell over 12% on September 26, 2025.
If you suffered a loss on your Organogenesis Holdings Inc. securities and would like to explore a potential recovery under the federal securities laws, submit to us or contact Joseph E. Levi, Esq. via email at [email protected] or call 212-363-7500 to speak to our team of experienced shareholder advocates.
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