Welcome to our dedicated page for Atara Biotherape news (Ticker: ATRA), a resource for investors and traders seeking the latest updates and insights on Atara Biotherape stock.
News about Atara Biotherapeutics, Inc. (NASDAQ: ATRA) centers on its development of allogeneic T-cell immunotherapies and the regulatory and business milestones associated with its Epstein-Barr virus (EBV)-specific platform. Atara describes itself as a leader in T-cell immunotherapy, focused on off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions, with headquarters in Southern California. Much of the company’s recent news flow has highlighted progress and challenges around tabelecleucel (tab-cel or EBVALLO), its EBV-specific T-cell therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Investors following ATRA news can expect updates on FDA interactions, including Biologics License Application (BLA) submissions, Priority Review status, Prescription Drug User Fee Act (PDUFA) target action dates, and Complete Response Letters. Releases have detailed how Atara and its partner Pierre Fabre Laboratories addressed Good Manufacturing Practice (GMP) observations, transferred the tabelecleucel IND and BLA, and responded to evolving FDA positions on the adequacy of the pivotal ALLELE study for accelerated approval.
Company news also covers financial results and corporate restructuring, such as quarterly earnings releases, changes in research and development and general and administrative expenses, workforce reductions, lease amendments, and the impact of tabelecleucel-related milestone payments and commercialization revenue. In addition, Atara has issued updates on its strategic alternatives review, describing potential transactions it may consider to maximize shareholder value.
For readers tracking ATRA, this news stream provides insight into Atara’s clinical and regulatory trajectory, its partnership with Pierre Fabre Laboratories on tabelecleucel/EBVALLO, and the company’s evolving cost structure and strategic direction. Regularly reviewing these updates can help contextualize movements in ATRA stock and developments in the EBV-focused cell therapy space.
Atara Biotherapeutics (Nasdaq: ATRA) amended its December 2022 Purchase and Sale Agreement with a fund managed by HealthCare Royalty to push a one-time $9.0 million milestone cash payment from June 30, 2026 to January 1, 2028.
In connection with the amendment, Atara issued a warrant for up to 400,000 common shares at an exercise price of $0.0001 per share, exercisable immediately with no expiration and subject to a beneficial ownership limit. Management cites time to address a recent CRL and to support partner Pierre Fabre on tabelecleucel regulatory work.
Pierre Fabre Pharmaceuticals (collaborating on ATRA program) announced receipt of a Complete Response Letter (CRL) from the U.S. FDA on Jan 9, 2026, stating the tabelecleucel Biologics License Application cannot be approved in its present form.
The company says the FDA acknowledged resolution of a prior GMP deficiency but now requests a new study, reversing prior acceptance of the single‑arm ALLELE study and creating an unexpected change after multi‑year dialogue. Pierre Fabre intends to engage the FDA with Atara Biotherapeutics and continue expanded access while pursuing a path toward accelerated approval.
Atara Biotherapeutics (Nasdaq: ATRA) announced the FDA issued a Complete Response Letter (CRL) on Jan 9, 2026 for the EBVALLO™ (tabelecleucel) BLA for EBV+ PTLD, stating the ALLELE single‑arm trial is no longer adequate for accelerated approval despite prior FDA alignment; GMP issues were resolved and no safety concerns were raised. Atara transferred the BLA to Pierre Fabre Pharmaceuticals in Nov 2025; PFP plans a Type A meeting expected within 45 days to seek a path to accelerated approval. Financially, cash and equivalents were approximately $8.5M as of Dec 31, 2025; milestone payments under amended commercialization terms were adjusted to <$b>$31M plus a potential <$b>$15M contingent payment. Atara implemented ~90% headcount reduction in 2025 and reduced ARC lease liability by ~65%.
Atara Biotherapeutics (Nasdaq: ATRA) reported Q3 2025 results and operational updates. The FDA accepted the BLA for tabelecleucel (tab-cel/Ebvallo) with Priority Review and a PDUFA target action date of January 10, 2026. Atara completed transfer of substantially all tab-cel activities and BLA sponsorship to Pierre Fabre, which would trigger a $40 million milestone payment upon FDA approval. Cash, cash equivalents and short-term investments were $13.7M as of September 30, 2025. Q3 net loss was $4.3M ($0.32/sh) versus $21.9M a year earlier; total revenues were $3.5M versus $40.2M in Q3 2024. Workforce reduced by ~29%, retaining ~15 employees.
Pierre Fabre Pharmaceuticals (ATRA) announced it has taken over the U.S. Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics, making Pierre Fabre responsible for global clinical development, regulatory, commercial, and manufacturing activities for the therapy.
The BLA is under FDA Priority Review with a PDUFA target action date of January 10, 2026. The submission covers more than 430 patients, and if approved tabelecleucel would be indicated as monotherapy for patients aged two years and older with EBV+ PTLD after at least one prior therapy. Manufacturing for global development and commercial access is being performed by Pierre Fabre in the U.S.
Atara Biotherapeutics (Nasdaq: ATRA), a T-cell immunotherapy company, announced significant changes to its Board of Directors. Greg Ciongoli, founder of Adiumentum Capital Management and Director since 2024, has been appointed as Chair of the Board and will serve on the Nominating and Corporate Governance Committee.
The company also announced the departure of three board members: Pascal Touchon, Maria Grazia Roncarolo, M.D., and Ameet Mallik, as part of efforts to right-size the board following the company's reduced footprint. The changes come as Atara positions itself following FDA acceptance of its resubmitted BLA for Ebvallo, with focus on maximizing value from Ebvallo milestones and its allogeneic CAR T portfolio.
Atara Biotherapeutics (Nasdaq: ATRA) has reported its Q2 2025 financial results and operational progress. The FDA has accepted the company's BLA for tabelecleucel (tab-cel®) with Priority Review, setting a PDUFA date of January 10, 2026. The therapy targets EBV+ PTLD in patients who have received prior therapy.
Key financial highlights include Q2 revenues of $17.6M, a net income of $2.4M ($0.20 per share), and cash reserves of $22.3M as of June 30, 2025. The company has transferred tab-cel operations to Pierre Fabre Laboratories and expects a $40M milestone payment upon FDA approval. Operating expenses are projected to decrease by over 60% in 2025 compared to 2024.
Atara has resumed evaluating strategic options, including potential acquisition, merger, or other business combinations.
Atara Biotherapeutics (NASDAQ: ATRA) announced that the FDA has accepted and granted Priority Review for tabelecleucel's Biologics License Application (BLA). Tabelecleucel is a groundbreaking treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), with a PDUFA date set for January 10, 2026.
The therapy, developed in collaboration with Pierre Fabre Pharmaceuticals (PFP), would be the first FDA-approved treatment for EBV+ PTLD patients who have failed prior therapy. The BLA submission includes data from over 430 patients, including the pivotal ALLELE study. Tabelecleucel has already received marketing authorization in Europe (EBVALLO™), the UK, and Switzerland.
Atara Biotherapeutics (Nasdaq: ATRA) announced that the FDA has accepted its Biologics License Application (BLA) for tabelecleucel (tab-cel®) with Priority Review status. The treatment is designed for adult and pediatric patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received prior therapy.
The FDA has set a PDUFA target action date of January 10, 2026. The BLA submission is supported by data from over 430 patients, including the pivotal ALLELE study which showed a significant 48.8% Objective Response Rate. If approved, tab-cel would become the first FDA-approved therapy for this indication.
Pierre Fabre Pharmaceuticals has taken over the Investigational New Drug (IND) Application for tabelecleucel from Atara Biotherapeutics (NASDAQ: ATRA). This transfer follows Atara's July 11 resubmission of the Biologics License Application (BLA) to the FDA, addressing manufacturing facility observations from January 2025's Complete Response Letter.
Pierre Fabre now manages all global clinical trial activities for tabelecleucel, including the pivotal Phase 3 ALLELE study and another trial for EBV-associated diseases. The company assumed global manufacturing responsibilities on March 31, including commercial supply for European markets where the therapy is already approved as EBVALLO®.
Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to target EBV-infected cells, approved in Europe since December 2022 for treating EBV+ PTLD in patients who have received prior therapy.