Atara Biotherapeutics' EBVALLO BLA Rejected by FDA, Stock Plummets 57%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Source: NASDAQ.COM
- FDA Rejection Letter: Atara Biotherapeutics received a Complete Response Letter (CRL) from the FDA for its EBVALLO Biologics License Application (BLA), indicating that the application cannot be approved in its current form, leading to a 56.99% drop in stock price to $5.88 during Monday's trading.
- Clinical Trial Issues: Although the FDA confirmed that GMP compliance issues were resolved, it reversed its previous stance on the adequacy of the single-arm ALLELE trial, stating that its design and analysis are confounded, which undermines Atara's strategic plans for accelerated approval.
- Transfer and Collaboration: In November 2025, Atara transferred the BLA to Pierre Fabre Pharmaceuticals, which plans to request a Type A meeting with the FDA within 45 days to identify a path forward for EBVALLO, highlighting the urgency of addressing patient needs.
- Patient Impact: Patients with EBV+ PTLD face extremely limited treatment options, and the urgent collaboration between Atara and Pierre Fabre aims to expedite communication with the FDA to provide effective treatment options, reflecting the company's crisis response strategy.
Analyst Views on ATRA
Wall Street analysts forecast ATRA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ATRA is 17.50 USD with a low forecast of 17.00 USD and a high forecast of 18.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 13.670
Low
17.00
Averages
17.50
High
18.00
Current: 13.670
Low
17.00
Averages
17.50
High
18.00
About ATRA
Atara Biotherapeutics, Inc. is an allogeneic T-cell immunotherapy company. The Company is a developer of T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with serious diseases. Its pipeline products include Ebvallo (Tab-cel), ATA3219, and ATA3431. The Company’s T-cell immunotherapy, tab-cel (tabelecleucel), is in Phase III development for patients with EBV-driven post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed rituximab or rituximab plus chemotherapy, as well as other EBV-driven diseases. Its ATA3219 allogeneic CD19 CAR T immunotherapy, targeting B-cell malignancies and autoimmune diseases, is based on a next-generation 1XX CAR co-stimulatory domain and EBV T-cell platform and does not require TCR or HLA gene editing. ATA3431 is an allogeneic, bispecific CAR directed against CD19 and CD20 for B-cell malignancies and autoimmune disease.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
