Atara Biotherapeutics, Inc. reported its third quarter 2026 financial results and provided an update on its regulatory submission for tabelecleucel (tab-cel) in a Form 8-K filed on November 10, 2026.
The company announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) resubmission for tabelecleucel. The resubmission seeks approval for the drug as monotherapy for the treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. The BLA has been assigned a Class 2 Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027.
If approved, Atara would be eligible to receive a $31 million milestone payment pursuant to its commercialization agreement with Pierre Fabre Laboratories. The company also noted it would be eligible for significant double-digit tiered royalties on net sales and additional milestones related to commercial sales of EBVALLO.
Financial results for the third quarter of 2026 included total revenues of $1.2 million, a decrease of $2.3 million year-over-year, primarily due to the one-time sale of clinical inventory in the prior year. The company reported a net loss of $2.2 million, or ($0.15) per share, for the quarter.
Atara highlighted significant cost reduction initiatives implemented in 2025 and the first half of 2026. The company stated that operating expenses are expected to decline significantly year-over-year in 2026 and that its current cash, cash equivalents, and short-term investments are expected to be sufficient to fund planned operations into mid-2027.
