The FDA delayed its decision on Orca Bio’s T cell therapy after the company filed additional manufacturing data, extending the agency’s review timeline by three months. The new decision deadline is July 6, after the agency had expected to reach a verdict by April 6. For cell therapy developers, the move spotlights how late-stage submission details—particularly manufacturing changes or supplemental CMC packages—can shift regulatory timing even when trial progress is otherwise on track. It also adds schedule risk for investigators, investors, and planning around potential commercial entry. Orca Bio’s revised timeline indicates the review remains tied to ensuring manufacturing consistency and product characterization for the therapy.