Pierre Fabre Pharmaceuticals Takes Over Tabelecleucel BLA From Atara Biotherapeutics Ahead Of FDA Priority Review On January 10, 2026 For First U.S. EBV+ PTLD Therapy

Tabelecleucel BLA currently under U.S. Food and Drug Administration (FDA) Priority Review as potentially the first approved therapy in the U.S. for EBV+ PTLD with a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026

First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment

EBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppression

Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development, regulatory, commercial, and manufacturing activities for tabelecleucel worldwide

SECAUCUS, N.J., Nov. 3, 2025 /PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. (PFP) announces the transfer of the Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics Inc. (NASDAQ:ATRA) with PFP now accountable for all aspects of the submission. Atara will continue to observe the regulatory process and provide support to PFP as needed. The tabelecleucel BLA has an FDA PDUFA target action date of January 10, 2026. If approved, the tabelecleucel will be indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with EBV+ PTLD who have received at least one prior therapy.

Atara resubmitted the tabelecleucel BLA on July 11, 2025 of this year, in collaboration with PFP, and the FDA accepted the tabelecleucel BLA with Priority Review on July 23.  With completion of the transfer of the BLA, Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development regulatory, commercial and manufacturing activities for tabelecleucel worldwide. The innovative cell therapy is manufactured by PFP in the US for global clinical development and commercial access.