Atara Biotherapeutics and Pierre Fabre Pharmaceuticals said they have resubmitted to the FDA for Ebvallo (tabelecleucel) after earlier rejections, as the partners seek approval for a post-transplant complication driven by Epstein-Barr virus. The therapy was initially developed for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The companies previously received complete response letters, including one tied to manufacturing issues and a later rejection related to the adequacy and interpretability of pivotal clinical data. The new resubmission is expected to be treated as a Class 2 BLA resubmission by analysts, which would align with a potential target action date in 2027. The companies argue the regulatory position has shifted again and that additional data included in the resubmission better supports the proposed path forward.