Atara Biotherapeutics Reports that the Tabelecleucel Biologics License Application Has Been Resubmitted to the U.S. Food and Drug Administration

On September 30, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported an update that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

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"We are grateful to the Agency for their continued guidance and engagement with our partner, PFP, and us," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We will continue to support PFP as it prepares for the review process and anticipate providing a revised anticipated PDUFA date as it becomes available."

PFP, with Atara’s support, has resubmitted the BLA based on the feedback received from the Type A meeting held in April. The resubmission includes an updated data package with additional patients, plus longer follow up from the ongoing, pivotal Phase 3 single arm ALLELE study of tabelecleucel in adults and children two years of age and older with relapsed/refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT). The resubmission also includes additional supplemental data from the expanded access programs, a separate clinical study, and commercial experience in Europe.

Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $31 million milestone payment upon FDA approval of the tabelecleucel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales.

(Press release, Atara Biotherapeutics, SEP 30, 2026, View Source [SID1234671179])