FDA Lifts Hold on Atara’s EBVALLO Program

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

On May 5, 2025, Atara Biotherapeutics announced that the FDA lifted the clinical hold on its EBVALLO™ (tabelecleucel) program, initially placed in January 2025 due to GMP compliance issues at a third-party manufacturing facility. This decision allows Atara to resume its Phase 3 ALLELE clinical study and a Phase 2 label-expansion study for patients with EBV-associated post-transplant lymphoproliferative disease. Additionally, the FDA granted a Type A meeting to discuss the path forward for resubmitting the Biologics License Application (BLA) for EBVALLO™. Atara has temporarily paused its strategic option evaluation pending clarity on the BLA resubmission timeline.

Spark’s Take on ATRA Stock

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

Atara Biotherapeutics showcases substantial revenue growth, yet its financial instability due to high liabilities and ongoing cash flow challenges significantly impact its attractiveness. Technical indicators highlight a lack of strong momentum, suggesting cautious investor sentiment. Additionally, the negative valuation metrics further underline financial risks, resulting in a low overall score.

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

More about Atara Biotherapeutics

Atara Biotherapeutics, Inc., headquartered in Southern California, is a leader in T-cell immunotherapy. The company leverages its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Atara is the first company to receive regulatory approval for an allogeneic T-cell immunotherapy and is focused on developing off-the-shelf cell therapies that target EBV, the root cause of certain diseases.

Average Trading Volume: 58,914

Technical Sentiment Signal: Sell

Current Market Cap: $46.62M

Learn more about ATRA stock on TipRanks’ Stock Analysis page.