Atara Biotherapeutics' Ebvallo Receives EU Approval, Faces Second FDA Rejection
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 14 2026
0mins
Source: Benzinga
- Clinical Trial Results: Atara's Ebvallo met its primary efficacy endpoint in the ALLELE trial, demonstrating an acceptable safety profile; however, the FDA raised concerns about the trial's interpretability, impacting the likelihood of accelerated approval.
- Regulatory Timeline: Ebvallo received EU marketing authorization on December 16, 2022, but faced a second Complete Response Letter from the FDA on January 9, 2026, citing deficiencies in trial design and analysis without raising manufacturing or safety issues.
- Financial Constraints: Atara is currently at an extremely constrained net liquidity level, having monetized part of its Ebvallo EU royalties through the HCRx transaction, but the FDA rejection leaves very few unencumbered assets or cash flow streams available for financing.
- Future Pathway: Atara and Pierre Fabre Pharmaceuticals will need to conduct an additional clinical trial to address the FDA's concerns, which is expected to increase costs and potentially extend timelines to 2-3 years, with Atara still bearing some financial impact.
Get Free Real-Time Notifications for Any Stock
Monitor tickers like ATRA with instant alerts to capture every critical market movement.
Sign up for free to build your custom watchlist and receive professional-grade stock notifications.
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 21.50 USD with a low forecast of 18.00 USD and a high forecast of 25.00 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: 5.500
Low
18.00
Averages
21.50
High
25.00
Current: 5.500
Low
18.00
Averages
21.50
High
25.00
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.
Atara Biotherapeutics Faces Securities Fraud Investigation
- FDA Rejection: On January 12, 2026, Atara announced that the FDA issued a Complete Response Letter for the EBVALLO™ Biologics License Application, indicating that the current application form cannot be approved, which impacts the company's future product launch plans.
- Clinical Trial Issues: The FDA stated that Atara's single-arm ALLELE trial is no longer considered adequate to support accelerated approval due to confounding issues in trial design and analysis, potentially undermining the evidence of effectiveness and harming the company's reputation.
- Stock Price Plunge: Following the FDA announcement, Atara's stock price fell by $7.79, a decline of 56.99%, closing at $5.88 per share, which directly affects investor confidence and may complicate future financing efforts.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Atara and its executives have engaged in securities fraud or other unlawful business practices, potentially leading to a class action lawsuit and exacerbating the legal risks faced by the company.
Continue Reading
Atara Biotherapeutics Under Investigation After 57% Stock Drop Following FDA Response
- FDA Response Impact: On January 12, 2026, Atara announced that the FDA issued a Complete Response Letter for the EBVALLO™ Biologics License Application, indicating that the application cannot be approved in its current form, resulting in a stock price drop of $7.79, or 56.99%.
- Clinical Trial Issues: The FDA stated that Atara's single-arm ALLELE trial is no longer considered adequate to support accelerated approval, with design and analysis flaws rendering the results difficult to interpret, directly impacting the company's market outlook.
- Investor Attention: Pomerantz LLP is investigating whether Atara and its executives engaged in securities fraud or other unlawful business practices, advising investors to contact the firm for more information, which may lead to a class action lawsuit.
- Potential Legal Consequences: This investigation could expose Atara to legal liabilities, further affecting shareholder confidence and market performance, prompting investors to closely monitor future developments.
Continue Reading