The FDA postponed its decision on Orca Bio’s T cell therapy by three months, extending the agency’s deadline to July 6. The delay follows the filing of additional manufacturing data, pushing the expected verdict from an earlier April 6 estimate. Orca Bio’s therapy targets malignancies through engineered T cells, with the regulatory timeline now aligned to an FDA review cycle focused on manufacturing readiness and quality control evidence. For cell-therapy developers, the update reinforces the central role of manufacturing dossiers in FDA review timing—particularly for therapies where process changes or data completeness can trigger schedule revisions. Investors and clinical teams will now have to recalibrate expectations around the potential outcome and any downstream planning contingent on an approval or complete response letter.