Atara Biotherapeutics Secures FDA Review for Tabelecleucel with Decision Date Set for January 2026.

Atara Biotherapeutics Inc. (ATRA) has received FDA acceptance of its Biologics License Application for Tabelecleucel, a treatment for Epstein-Barr virus-positive post-transplant lymphoproliferative disease. The regulatory decision is expected on January 10, 2026. This is the company's second attempt at approval, following a previous rejection due to issues in a third-party manufacturing facility. Tabelecleucel is already approved in Europe, the UK, and Switzerland.

Atara Biotherapeutics Inc. (ATRA) has achieved a significant milestone in its quest to bring innovative cancer treatments to market. The company announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for tabelecleucel (tab-cel®), a therapy targeting Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The regulatory decision is expected on January 10, 2026 [1].

This is Atara's second attempt at securing FDA approval for tabelecleucel. The initial application was rejected due to issues related to a third-party manufacturing facility. The company has since collaborated with Pierre Fabre Pharmaceuticals (PFP) to address these concerns and successfully resubmitted the BLA on July 11 [2].

Tabelecleucel is an allogeneic, off-the-shelf EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by extensive clinical data, including a pivotal study (ALLELE) that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p0.0001) and a favorable safety profile [1].

The FDA granted the BLA Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. This designation indicates the FDA's commitment to reviewing the application expeditiously, aiming to make this first-of-its-kind therapy available to patients in the U.S. [1].

Atara's CEO, Cokey Nguyen, commented on the development, stating, "The acceptance of the tab-cel resubmission moves us one step closer towards making this first-of-its-kind treatment available to patients in the U.S. We continue to work closely with the Pierre Fabre Pharmaceuticals team to help prepare for the potential launch in the U.S." [1].

Tabelecleucel has already received approval in Europe, the UK, and Switzerland, demonstrating its potential to make a significant impact on patients' lives globally. The company's strategic partnership with PFP is expected to streamline the manufacturing process and facilitate the global rollout of the therapy [2].

Wall Street analysts have shown optimism about Atara's prospects. Based on the one-year price targets offered by 3 analysts, the average target price for Atara Biotherapeutics Inc. is $15.33, with a high estimate of $18.00 and a low estimate of $11.00. The average target implies an upside of 25.07% from the current price of $12.26 [2].

Atara's stock has been trading at $12.26 as of July 2, 2025. The estimated GF Value for Atara Biotherapeutics Inc. in one year is $137.59, suggesting a potential upside of 1022.27% from the current price [2].

References
1. [1] https://finance.yahoo.com/news/atara-biotherapeutics-announces-u-fda-120000453.html
2. [2] https://www.gurufocus.com/news/3001939/fda-accepts-atara-biotherapeutics-bla-for-tabelecleucel-atra-atra-stock-news