Ernexa Therapeutics Completes Pre‑IND Meeting With FDA, Secures Pathway To IND And First‑In‑Human Ovarian Cancer Trial In H2 2026

Regulatory alignment supports rapid progress, tech transfer already underway to accelerate clinical readiness

Company on track to initiate first-in-human (FIH) trial for the treatment of ovarian cancer in the second half of 2026

CAMBRIDGE, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (NASDAQ:ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the successful completion of its recent Pre-Investigational New Drug Application (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). Feedback from the FDA provided strong regulatory alignment on Ernexa's development approach and set a clear pathway toward submitting the IND and initiating its first-in-human (FIH) trial for the treatment of ovarian cancer, expected in the second half of 2026.

Following the meeting, Ernexa has accelerated key operational activities. Tech transfer – one of the most significant milestones in preparing for clinical manufacturing – is already underway, positioning the company to rapidly advance toward production of clinical-grade material and trial readiness.