Pierre Fabre Pharmaceuticals Announces Transfer from Atara Biotherapeutics of the Biologics License Application (BLA) for Tabelecleucel as Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 03 2025
0mins
Should l Buy ATRA?
Source: PRnewswire
Tabelecleucel BLA Submission: The Biologics License Application (BLA) for tabelecleucel is under FDA Priority Review, with a target action date of January 10, 2026, potentially marking it as the first approved therapy for EBV+ PTLD in the U.S.
Significance for Patients: Tabelecleucel offers hope for patients with EBV+ PTLD, a rare and deadly blood malignancy, especially for those who have limited treatment options and a very short lifespan following initial treatment failure.
Transfer of Responsibilities: Pierre Fabre Pharmaceuticals has taken over all clinical development, regulatory, commercial, and manufacturing activities for tabelecleucel, having transferred the BLA from Atara Biotherapeutics.
Innovative Therapy Details: Tabelecleucel is an allogeneic, off-the-shelf T-cell immunotherapy targeting EBV-infected cells, with data from over 430 patients included in the BLA, highlighting its potential effectiveness in treating relapsed or refractory cases.
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Analyst Views on ATRA
Wall Street analysts forecast ATRA stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 4.450
Low
18.00
Averages
21.50
High
25.00
Current: 4.450
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 its EBVALLO™ Biologics License Application, indicating that the application cannot be approved in its current form due to the inadequacy of the single-arm ALLELE trial, which jeopardizes the company's future product launch plans.
- Stock Price Plunge: Following the FDA announcement, Atara's stock price plummeted by $7.79, a staggering 56.99% drop, closing at $5.88 per share, which may undermine investor confidence and impact the company's ability to raise funds.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Atara and its executives have engaged in securities fraud or other unlawful business practices, advising investors to contact the firm to join the class action, which could exacerbate the legal risks facing the company.
- Market Reaction Intensifies: The FDA's rejection and the subsequent stock collapse have created significant uncertainty regarding Atara's future prospects, potentially affecting its reputation and attractiveness to investors in the biopharmaceutical industry.
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 Faces Securities Fraud Investigation
- 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 due to the inadequacy of the single-arm ALLELE trial, which jeopardizes the company's future product launch plans.
- Stock Price Plunge: Following the FDA announcement, Atara's stock price plummeted by $7.79, a staggering 56.99% drop, closing at $5.88 per share, which may undermine investor confidence and impact the company's ability to raise funds.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Atara and its executives have engaged in securities fraud or other unlawful business practices, advising investors to contact the firm to join the class action, which could exacerbate the legal risks facing the company.
- Market Reaction Intensifies: The FDA's rejection and the subsequent stock collapse have created significant uncertainty regarding Atara's future prospects, potentially affecting its reputation and attractiveness to investors in the biopharmaceutical industry.
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
