Pierre Fabre and Atara Biotherapeutics resubmitted Ebvallo (tabelecleucel) to the FDA after two prior rejections tied to manufacturing and trial interpretability concerns for Epstein-Barr virus–positive PTLD following transplantation. The partners say the new submission reflects updated data and alignment with the agency’s feedback. Atara and Pierre Fabre previously reported that the first CRL was “solely related” to inspection findings at a third-party manufacturer. The second CRL, delivered after GMP compliance issues were said to be resolved, criticized the single-arm ALLELE Phase 3 dataset as insufficient for a BLA—despite prior acceptance signals. Analysts cited in the report expect the revised filing to be treated as a Class 2 BLA resubmission, putting a potential target action date in March 2027. The case highlights how cell therapy approvals can hinge on both manufacturing quality systems and regulatory interpretation of clinical evidence design.