Atara Biotherapeutics' EBVALLO BLA Rejected by FDA, Stock Plummets 57%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 13 2026
0mins
Should l Buy ATRA?
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.
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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: 4.880
Low
18.00
Averages
21.50
High
25.00
Current: 4.880
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.
Pomerantz LLP Investigates Securities Fraud Claims Against Atara Biotherapeutics
- Investigation Launched: Pomerantz LLP is investigating claims on behalf of Atara Biotherapeutics investors regarding potential securities fraud or other unlawful business practices, indicating serious concerns about the company's governance.
- FDA Application Denied: On January 12, 2026, Atara announced that its EBVALLO™ Biologics License Application was rejected by the FDA via a Complete Response Letter (CRL), indicating that the application is currently inadequate for approval, which impacts the company's future product launch plans.
- Stock Price Plummets: Following the FDA's CRL announcement, Atara's stock price fell by $7.79, a decline of 56.99%, closing at $5.88 per share, reflecting market pessimism regarding the company's outlook.
- Legal Implications: Pomerantz LLP, recognized for its expertise in securities litigation, may provide legal support to affected investors, further intensifying the legal and financial pressures faced by Atara.
See More
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.
See More
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.
See More
Atara Biotherapeutics Under Investigation After 57% Stock Drop Following FDA Response
- FDA Rejection: On January 12, 2026, Atara announced that the FDA issued a Complete Response Letter for its EBVALLO™ Biologics License Application, indicating that the application cannot be approved in its current form, which jeopardizes 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, with concerns over trial design and analysis potentially leading to insufficient evidence of efficacy, impacting the company's credibility.
- Significant Stock Drop: Following the FDA announcement, Atara's stock plummeted by $7.79, a 56.99% decline, closing at $5.88 per share, which directly affects investor confidence and may lead to further legal actions.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Atara and its executives engaged in securities fraud or other unlawful business practices, potentially triggering a class action lawsuit and increasing the legal risks faced by the company.
See More
Atara Biotherapeutics' Ebvallo Receives EU Approval, Faces Second FDA Rejection
- 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.
See More
Atara Biotherapeutics' EBVALLO BLA Rejected by FDA, Stock Plummets 57%
- 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.
See More
Pomerantz LLP Investigates Securities Fraud Claims Against Atara Biotherapeutics
- Investigation Launched: Pomerantz LLP is investigating claims on behalf of Atara Biotherapeutics investors regarding potential securities fraud or other unlawful business practices, indicating serious concerns about the company's governance.
- FDA Application Denied: On January 12, 2026, Atara announced that its EBVALLO™ Biologics License Application was rejected by the FDA via a Complete Response Letter (CRL), indicating that the application is currently inadequate for approval, which impacts the company's future product launch plans.
- Stock Price Plummets: Following the FDA's CRL announcement, Atara's stock price fell by $7.79, a decline of 56.99%, closing at $5.88 per share, reflecting market pessimism regarding the company's outlook.
- Legal Implications: Pomerantz LLP, recognized for its expertise in securities litigation, may provide legal support to affected investors, further intensifying the legal and financial pressures faced by Atara.
See More
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.
See More
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.
See More
Atara Biotherapeutics Under Investigation After 57% Stock Drop Following FDA Response
- FDA Rejection: On January 12, 2026, Atara announced that the FDA issued a Complete Response Letter for its EBVALLO™ Biologics License Application, indicating that the application cannot be approved in its current form, which jeopardizes 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, with concerns over trial design and analysis potentially leading to insufficient evidence of efficacy, impacting the company's credibility.
- Significant Stock Drop: Following the FDA announcement, Atara's stock plummeted by $7.79, a 56.99% decline, closing at $5.88 per share, which directly affects investor confidence and may lead to further legal actions.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Atara and its executives engaged in securities fraud or other unlawful business practices, potentially triggering a class action lawsuit and increasing the legal risks faced by the company.
See More
Atara Biotherapeutics' Ebvallo Receives EU Approval, Faces Second FDA Rejection
- 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.
See More
Atara Biotherapeutics' EBVALLO BLA Rejected by FDA, Stock Plummets 57%
- 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.
See More
