ERNA shares surge 13.21% premarket after successful FDA Pre-IND meeting clears path for ovarian cancer trial.

Ernexa Therapeutics (NASDAQ: ERNA) surged 13.21% in premarket trading following the announcement of a successful Pre-IND FDA meeting, which validated its development strategy for ERNA-101, an allogeneic cell therapy targeting ovarian cancer. The FDA’s regulatory alignment cleared the pathway for submitting an IND application and initiating a first-in-human trial in the second half of 2026. The company also disclosed that tech transfer for clinical manufacturing is underway, accelerating trial readiness. These developments, coupled with the potential to address a critical unmet need in ovarian cancer treatment, bolstered investor confidence in the stock’s long-term prospects.