Atara Biotherapeutics (Nasdaq: ATRA) announced that the U.S. Food and Drug Administration has accepted a resubmitted Biologics License Application (BLA) for tabelecleucel, a therapy proposed for treating Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in adult and pediatric patients two years of age and older who have received at least one prior therapy.

The BLA was submitted by Atara's partner, Pierre Fabre Pharmaceuticals, Inc., and has been classified as a Class 2 Resubmission. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027.

If approved, tabelecleucel would be the first therapy available in the U.S. for EBV+ PTLD, according to the company's press release. The drug has previously received Breakthrough Therapy Designation for rituximab-refractory EBV-associated lymphoproliferative disease and orphan drug designation for EBV-positive post-transplant lymphoproliferative disorders from the FDA.

Under its commercialization agreement with Pierre Fabre Laboratories, Atara would be eligible to receive a $31 million milestone payment upon FDA approval. The company would also be eligible for double-digit tiered royalties on net sales and additional commercial sales milestones.

"The acceptance of the tabelecleucel resubmission brings us one step closer to making this first-of-its-kind treatment available to patients in the U.S.," said Cokey Nguyen, President and Chief Executive Officer of Atara.