Atara Biotherapeutics resubmits tab-cel application to FDA

Atara Biotherapeutics Inc. (NASDAQ: ATRA) has resubmitted a Biologics License Application to the U.S. Food and Drug Administration for tabelecleucel, a treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease in adult and pediatric patients two years and older who have received at least one prior therapy.

The resubmission addresses third-party manufacturing facility observations outlined in a January 2025 Complete Response Letter from the FDA. Currently, no FDA-approved therapies exist for this treatment setting.

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The application is supported by data from more than 430 patients treated with tab-cel across multiple diseases, including the ALLELE study that demonstrated a 48.8% Objective Response Rate.

The therapy has received Breakthrough Therapy Designation from the FDA for rituximab-refractory EBV-associated lymphoproliferative disease and orphan drug designation for EBV-positive post-transplant lymphoproliferative disorders.

Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA, along with double-digit tiered royalties and commercial sales milestones.

The company is finalizing the transfer of clinical studies associated with tab-cel to Pierre Fabre Laboratories. Upon completion, substantially all operational activities and associated costs related to tab-cel will transfer to Pierre Fabre, while Atara continues to maintain BLA sponsorship.

Atara projects its cash, cash equivalents and short-term investments of approximately $22 million as of June 30, 2025, combined with cost reduction initiatives, will fund operations into the first quarter of 2026.

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