Ernexa Therapeutics Announces Successful Pre-IND FDA Meeting and Continues Progress Toward First-in-Human Trial in Ovarian Cancer
Ernexa Therapeutics Inc. (ERNA)
Company Research
Source: GlobeNewswire
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 pre
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News
- Ernexa Therapeutics Presents New Preclinical Data at American Society of Hematology (ASH) Annual Meeting on Lead Cell Therapy Candidate for Treatment of Ovarian CancerGlobeNewswire
- Ernexa Therapeutics Announces Oral Presentation at the 67th American Society of Hematology (ASH) Annual MeetingGlobeNewswire
- Ernexa Therapeutics Strengthens Scientific and Medical Advisory Board with Appointment of Leading Oncologist Dr. Ira S. Winer, M.D., Ph.D., FACOGGlobeNewswire
- Ernexa Therapeutics to Present at Oxford Global's Cell 2025 [Yahoo! Finance]Yahoo! Finance
- Ernexa Therapeutics to Present at Oxford Global’s Cell 2025GlobeNewswire
ERNA
Sec Filings
- 12/19/25 - Form SCHEDULE
- 12/16/25 - Form SCHEDULE
- 12/11/25 - Form 8-K
- ERNA's page on the SEC website