FDA rejects Atara Biotherapeutics' EBVALLO drug application

The U.S. Food and Drug Administration issued a Complete Response Letter rejecting Atara Biotherapeutics Inc.'s (NASDAQ: ATRA) application for EBVALLO (tabelecleucel), a treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease.

The FDA stated that the single-arm ALLELE trial no longer provides adequate evidence of effectiveness for accelerated approval, reversing its previous position that the trial design was acceptable. The agency cited concerns about the trial's study design, conduct and analysis, according to the company's statement.

Atara had resubmitted the Biologics License Application in 2025 after addressing Good Manufacturing Practice compliance issues identified in an initial rejection letter from January 2025. The FDA confirmed those manufacturing issues were resolved and raised no safety concerns in the latest rejection.

Pierre Fabre Pharmaceuticals Inc., which acquired the application rights in November 2025, plans to request a Type A meeting with the FDA within 45 days to discuss a path forward.

EBVALLO received Orphan Drug designation and Breakthrough Therapy status for treating adult and pediatric patients with EBV+ PTLD who have received at least one prior therapy including an anti-CD20 containing regimen.

Atara reported cash, cash equivalents and short-term investments of approximately $8.5 million as of December 31, 2025. The company reduced its workforce by approximately 90% in 2025 and transferred most tabelecleucel-related activities to Pierre Fabre Laboratories.

Under an amended commercialization agreement, Atara reduced the milestone payment due upon BLA approval to $31 million in exchange for the right to receive an additional $15 million upon achieving a certain commercial milestone.

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