Ernexa Therapeutics Inc. has announced the successful completion of a Pre-Investigational New Drug Application (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA), achieving strong regulatory alignment for its development strategy. This feedback from the FDA sets a clear pathway for Ernexa to submit an IND and initiate its first-in-human trial for ovarian cancer in the second half of 2026. The company is advancing operational activities, including tech transfer, to accelerate clinical readiness for its lead therapy, ERNA-101, targeting ovarian cancer.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ernexa Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9620251-en) on January 06, 2026, and is solely responsible for the information contained therein.