Successful Pre-IND FDA Meeting and Continued Progress Toward First-in-Human Trial of ERNA-101 in Ovarian Cancer Announced
“We are very pleased with the outcome of our engagement with the FDA,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “The Agency’s feedback validates our development strategy and gives us the green light to move forward with urgency. With tech transfer now in progress, we are operating at full speed to bring our first-in-human studies online in 2026. This is a major step toward delivering transformative cell therapies to patients with serious and underserved diseases.”
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