Ernexa shares surge 23.17% premarket after successful FDA Pre-IND meeting and advancing toward first-in-human ovarian cancer trial.

Ernexa Therapeutics (NASDAQ: ERNA) surged 23.17% in premarket trading following the announcement of a successful Pre-Investigational New Drug (Pre-IND) meeting with the FDA. The regulatory feedback confirmed alignment with Ernexa’s development strategy for its lead ovarian cancer therapy, ERNA-101, and cleared the path for submitting an IND application and initiating a first-in-human trial by late 2026. The company also disclosed that tech transfer for clinical manufacturing is underway, accelerating trial readiness. These developments validate Ernexa’s progress toward scalable, off-the-shelf cell therapies and reduce regulatory uncertainty, driving immediate investor optimism. The news coincides with institutional buying, including a 2,400% position increase by Corient Private Wealth, further reinforcing confidence in the company’s advancing pipeline.