FDA Rejects Atara’s EBVALLO BLA, Commercial Path Uncertain

An update from Atara Biotherapeutics ( (ATRA) ) is now available.

On January 12, 2026, Atara Biotherapeutics reported that the U.S. Food and Drug Administration issued a Complete Response Letter for EBVALLO (tabelecleucel), rejecting its Biologics License Application as a monotherapy for EBV-positive post-transplant lymphoproliferative disease in adults and children, despite previously resolving manufacturing compliance issues and raising no new safety concerns. The FDA, reversing its earlier stance, now deems the single-arm ALLELE trial inadequate to demonstrate effectiveness for accelerated approval, prompting Atara’s U.S. commercialization partner Pierre Fabre to seek a Type A meeting as the companies work to salvage a path forward for the therapy, while Atara continues a deep restructuring marked by a roughly 90% headcount reduction in 2025, amended commercialization milestones, a significant lease downsizing, and year-end 2025 cash, cash equivalents and short-term investments of about $8.5 million, subject to audit.

The most recent analyst rating on (ATRA) stock is a Hold with a $18.00 price target. To see the full list of analyst forecasts on Atara Biotherapeutics stock, see the ATRA Stock Forecast page.

Spark’s Take on ATRA Stock

According to Spark, TipRanks’ AI Analyst, ATRA is a Neutral.

The score is held down primarily by weak financial performance—negative equity and continued negative operating/free cash flow outweigh recent margin improvement. Technicals are moderately supportive with an improving uptrend and positive MACD, while valuation is somewhat attractive on a low P/E but is tempered by the company’s financial risk.

To see Spark’s full report on ATRA stock, click here.

More about Atara Biotherapeutics

Atara Biotherapeutics, headquartered in Southern California, is a biotechnology company specializing in off-the-shelf allogeneic T-cell immunotherapies targeting Epstein-Barr virus (EBV) for difficult-to-treat cancers and autoimmune conditions. Leveraging a proprietary EBV T-cell platform that avoids T-cell receptor or HLA gene editing, Atara has built a portfolio of investigational therapies and is the first company to receive regulatory approval globally for an allogeneic T-cell immunotherapy.

Average Trading Volume: 80,025

Technical Sentiment Signal: Sell

Current Market Cap: $125.7M

See more insights into ATRA stock on TipRanks’ Stock Analysis page.