Atara and Pierre Fabre resubmit Ebvallo cell therapy after second FDA rejection

Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have filed a new FDA submission for their cell therapy candidate Ebvallo (tabelecleucel), aimed at treating Epstein‑Barr virus‑positive post‑transplant lymphoproliferative disease (EBV+ PTLD), a rare complication after solid organ transplants.

The therapy had previously received two complete response letters (CRLs), the most recent in January, after the FDA reversed earlier guidance following the departure of former commissioner Marty Makary. The new filing includes additional data that analysts at Mizhuo expect to qualify as a Class 2 Biologics License Application, which could set a target action date of March 29, 2027.

Analysts view the resubmission as a positive alignment with the agency, but the outcome remains uncertain. If approved, Ebvallo would address an unmet need for patients with EBV+ PTLD, a life‑threatening condition with limited treatment options.