Two CRLs deep, FDA now backs the same single-arm data it once rejected — a third review decides everything

Atara Biotherapeutics is a clinical-stage company developing a cell therapy for post-transplant lymphoma, a rare and deadly cancer that arises after organ transplant, which is not yet approved.

Tabelecleucel, an allogeneic EBV-specific T-cell therapy for a rare and lethal post-transplant lymphoma, has received two Complete Response Letters, the second reversing FDA's own prior acceptance of the single-arm ALLELE trial. Whether the thesis survives rests entirely on FDA approving the resubmission on data it has already twice evaluated. With $10M cash and a mid-2027 runway, the company reaches the next regulatory decision without a financing crisis, but a third rejection would be structurally fatal.