Atara Biotherapeutics (ATRA) Company Report

Pomerantz LLP is investigating Atara Biotherapeutics, Inc. for potential securities fraud or unlawful business practices.
On January 12, 2026, Atara announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its EBVALLO™ (tabelecleucel) Biologics License Application (BLA).
The FDA indicated it could not approve the BLA because the ALLELE trial was considered inadequate to support accelerated approval and its interpretability was confounded by trial design, conduct, and analysis.
Following this news, Atara's stock price fell $7.79 per share, or 56.99%, to close at $5.88 per share on January 12, 2026.

4 days ago

Press Release

Atara Biotherapeutics receives FDA Complete Response Letter for EBVALLO™ BLA

ATRA

Legal Proceedings

Product Launch

Pomerantz LLP is investigating Atara Biotherapeutics, Inc. (ATRA) for potential securities fraud or unlawful business practices on behalf of investors.
On January 12, 2026, Atara announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its EBVALLO™ (tabelecleucel) Biologics License Application (BLA).
The FDA indicated that the single-arm ALLELE trial was no longer considered adequate to support the BLA filing for accelerated approval, and its interpretability was confounded.
Following this announcement, Atara's stock price fell $7.79 per share, or 56.99%, to close at $5.88 per share on January 12, 2026.

Jan 27, 2026, 5:47 PM

Press Release

Atara Biotherapeutics Faces Investigation Following FDA Complete Response Letter

ATRA

Legal Proceedings

Product Launch

Pomerantz LLP is investigating Atara Biotherapeutics, Inc. (ATRA) for potential securities fraud or unlawful business practices.
The investigation follows Atara's announcement on January 12, 2026, that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its EBVALLO™ (tabelecleucel) Biologics License Application (BLA).
The FDA stated it could not approve the BLA in its present form because the single-arm ALLELE trial is no longer considered adequate to support accelerated approval, citing issues with trial design, conduct, and analysis.
Following this news, Atara's stock price fell $7.79 per share, or 56.99%, to close at $5.88 per share on January 12, 2026.

Jan 20, 2026, 6:13 PM

Press Release

Atara Biotherapeutics Receives FDA Complete Response Letter for EBVALLO BLA and Provides Financial Update

ATRA

Product Launch

Guidance Update

Profit Warning

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Atara Biotherapeutics' EBVALLO (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
The FDA's CRL indicated that the single arm ALLELE trial is no longer considered adequate to provide evidence of effectiveness for accelerated approval, citing issues with trial design, conduct, and analysis, which is a reversal of their prior position. GMP compliance issues from a previous CRL were resolved, and no safety issues were raised in the current CRL.
As of December 31, 2025, Atara's cash, cash equivalents and short-term investments totaled approximately $8.5 million.
In 2025, the company implemented significant operational efficiencies, including an approximately 90% reduction in headcount year over year, and transferred substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories.

Jan 12, 2026, 9:00 PM

8-K

Atara Biotherapeutics Receives FDA Complete Response Letter for EBVALLO™ BLA

ATRA

Product Launch

Guidance Update

Layoffs

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Atara Biotherapeutics' EBVALLO™ (tabelecleucel) Biologics License Application (BLA), indicating it cannot be approved in its present form.
The FDA's CRL cited that the single-arm ALLELE trial is no longer considered adequate to provide evidence of effectiveness for accelerated approval, a reversal of its prior guidance and alignment with Atara.
As of December 31, 2025, Atara reported approximately $8.5 million in cash, cash equivalents, and short-term investments.
In 2025, Atara implemented significant operational efficiencies, including an approximately 90% reduction in headcount year over year and transitioning most tab-cel activities and costs to Pierre Fabre Laboratories.
The commercialization agreement with Pierre Fabre Medicament was amended in December 2025, reducing the BLA approval milestone payment to $31 million while adding a potential $15 million commercial milestone payment upon achieving a certain commercial milestone.

Jan 12, 2026, 1:00 PM

Press Release

Atara Biotherapeutics Announces Q3 2025 Financial Results and Tab-cel BLA Update

ATRA

Earnings

Guidance Update

Layoffs

Atara Biotherapeutics reported a net loss of $4.3 million (or $0.32 per share) for Q3 2025, an improvement from a net loss of $21.9 million (or $2.93 per share) in Q3 2024. Total revenues for Q3 2025 were $3.5 million, a decrease from $40.2 million in the same period in 2024, primarily due to accelerated recognition of deferred revenue in prior periods.
The FDA has accepted the Biologics License Application (BLA) for tabelecleucel (tab-cel®) with Priority Review, setting a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.
Atara completed the transfer of substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories, with a $40 million milestone payment contingent upon FDA approval of the tab-cel BLA.
The company implemented an organizational restructuring in October 2025, reducing its workforce by approximately 29%, and projects a decrease in full-year 2025 operating expenses by at least 60% compared to 2024.

Nov 12, 2025, 2:05 PM

8-K

Atara Biotherapeutics Announces Third Quarter 2025 Financial Results and Tab-cel BLA Update

ATRA

Earnings

Guidance Update

Layoffs

Atara Biotherapeutics reported a net loss of $4.3 million for the third quarter of 2025, an improvement from a $21.9 million net loss in the same period of 2024, despite total revenues decreasing to $3.5 million from $40.2 million year-over-year.
The company's cash, cash equivalents, and short-term investments totaled $13.7 million as of September 30, 2025.
The U.S. FDA has accepted the Biologics License Application (BLA) for tabelecleucel (tab-cel®) with a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.
Atara expects to receive a $40 million milestone payment from Pierre Fabre Laboratories upon FDA approval of the tab-cel BLA. The company has also transferred substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories and implemented an organizational restructuring in October 2025, reducing its workforce by approximately 29%. This is expected to contribute to a projected decrease of at least 60% in full-year 2025 operating expenses compared to 2024.

Nov 12, 2025, 2:00 PM

Press Release

Atara Biotherapeutics Transfers Tabelecleucel BLA to Pierre Fabre Pharmaceuticals

ATRA

M&A

New Projects/Investments

Pierre Fabre Pharmaceuticals (PFP) has announced the transfer of the Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics Inc. (ATRA) as of November 3, 2025.
PFP is now responsible for all clinical development, regulatory, commercial, and manufacturing activities for tabelecleucel worldwide, with Atara providing support as needed.
The FDA PDUFA target action date for the tabelecleucel BLA is January 10, 2026.
Tabelecleucel is an investigational, allogeneic T-cell therapy for EBV+ PTLD, an ultra-rare and potentially deadly blood malignancy that currently has limited treatment options.

Nov 3, 2025, 2:00 PM

Press Release

Atara Biotherapeutics Announces Board Changes

ATRA

Board Change

Greg Ciongoli has been appointed Chair of the Board of Directors at Atara Biotherapeutics and will also serve on the Nominating and Corporate Governance Committee.
Pascal Touchon, Maria Grazia Roncarolo, M.D., and Ameet Mallik are stepping down from the Board of Directors.
These board changes are intended to reflect Atara's reduced company size and to right-size the board in line with its smaller footprint.
The company is positioned to consider value-maximizing options for its Ebvallo milestones and royalties, and its allogeneic CAR T portfolio, following the FDA's acceptance of the resubmitted BLA and reduced operating costs.