Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving Atara Biotherapeutics, Inc. following a significant stock price drop after the FDA's Complete Response Letter regarding its drug EBVALLO™ [1][3]. Group 1: Company Overview - Atara Biotherapeutics, Inc. is a biopharmaceutical company focused on developing therapies for patients with serious diseases [1]. - The company’s stock experienced a dramatic decline of 56.99%, falling $7.79 to close at $5.88 per share on January 12, 2026, after the FDA's announcement [3]. Group 2: FDA Response - On January 12, 2026, Atara announced that the FDA issued a Complete Response Letter (CRL) for its EBVALLO™ Biologics License Application (BLA) for treating Epstein-Barr virus positive post-transplant lymphoproliferative disease [3]. - The CRL indicated that the FDA could not approve the BLA in its current form, citing inadequacies in the evidence of effectiveness from the single arm ALLELE trial [3].

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving Atara Biotherapeutics, following a significant stock price drop after the FDA's Complete Response Letter regarding its EBVALLO™ treatment [1][3]. Group 1: Company Overview - Atara Biotherapeutics, Inc. (NASDAQ: ATRA) is under investigation for possible securities fraud or other unlawful business practices [1]. - The company recently faced a setback when the FDA issued a Complete Response Letter for its EBVALLO™ Biologics License Application, indicating that the application could not be approved in its current form [3]. Group 2: FDA Response and Impact - The FDA's Complete Response Letter stated that the single-arm ALLELE trial, previously deemed adequate for the BLA filing, is now considered insufficient for demonstrating effectiveness for accelerated approval [3]. - Following the FDA's announcement, Atara's stock price plummeted by $7.79 per share, a decrease of 56.99%, closing at $5.88 per share on January 12, 2026 [3].

Financial Position - As of December 31, 2025, Atara Biotherapeutics reported its cash, cash equivalents, and short-term investments, although specific figures were not disclosed in the preliminary estimate[6] Regulatory Challenges - The U.S. FDA issued a Complete Response Letter for the EBVALLO™ (tabelecleucel) Biologics License Application, indicating regulatory challenges for the product[7]

Core Insights - Atara Biotherapeutics is focusing on allogeneic CAR T-cell therapy, which is a novel approach in engineered cell therapies [1] Company Analysis - The company has shown potential in the biotech sector, particularly in the development of innovative therapies [1] - The analyst has a background in biochemistry and extensive experience in analyzing clinical trials and biotech companies, indicating a strong foundation for evaluating Atara's prospects [1] Industry Context - The article emphasizes the importance of understanding the science behind biotech investments, highlighting the complexities and potential pitfalls in the industry [1]

Regulatory Approvals and Commercialization - Atara Biotherapeutics received marketing authorization approval for its lead program, Tab-cel (Ebvallo), for commercial sale in the European Economic Area, the UK, and Switzerland[148]. - Tab-cel, under the name Ebvallo, is approved for commercial sale in the EEA, UK, and Switzerland, with ongoing Phase 3 trials in the U.S. for EBV+ PTLD patients[165]. - The Prescription Drug User Fee Act target action date for the tab-cel BLA is set for January 10, 2026[169]. Financial Performance - Commercialization revenue for the nine months ended September 30, 2025, was $119.2 million, a decrease of $36.7 million compared to $96.2 million in the same period of 2024[185]. - The cost of commercialization revenue for the nine months ended September 30, 2025, was $21.1 million, a decrease of $7.5 million from $14.2 million in the same period of 2024[186]. - Research and development expenses for the nine months ended September 30, 2025, totaled $37.7 million, a decrease of $85.1 million compared to $122.8 million in the same period of 2024[187]. - The accumulated deficit as of September 30, 2025, was $2.0 billion, with net losses of $72.7 million for the nine months ended September 30, 2024[173]. - General and administrative expenses decreased to $4.0 million in Q3 2025 from $10.4 million in Q3 2024, a reduction of 61%[190]. - Interest income fell to $0.2 million in Q3 2025 from $0.5 million in Q3 2024, a decrease of 60%[191]. - Total cash, cash equivalents, and short-term investments decreased to $13.7 million as of September 30, 2025, down from $42.5 million as of December 31, 2024, a decline of 68.6%[199]. - Cash and cash equivalents as of September 30, 2025, were $5.7 million, down from $25.0 million as of December 31, 2024, a decrease of 77.2%[199]. - Net cash used in operating activities was $45.2 million for the nine months ended September 30, 2025, compared to $44.2 million in the same period of 2024, an increase of 2.3%[201]. - Net cash provided by financing activities was $16.1 million in the nine months ended September 30, 2025, down from $59.6 million in the same period of 2024, a decrease of 73%[200]. - As of September 30, 2025, the company had $87.2 million of common stock remaining to be sold under the 2023 ATM Facility[195]. - The company expects a $40 million milestone payment from Pierre Fabre upon approval of the tab-cel BLA, which will provide significant cash runway[204]. - The company incurred losses and negative cash flows from operations since inception and anticipates needing additional capital to fund operations[197]. - The company may need substantial additional funding to complete the regulatory approval process for tab-cel in the US[207]. Workforce and Restructuring - The company executed workforce reductions of approximately 30% in November 2023, resulting in restructuring charges of $6.7 million[156]. - A further workforce reduction of approximately 50% was announced in January 2025, with total severance and related benefits recognized at approximately $7.1 million[158]. Strategic Alternatives and Collaborations - The company has engaged a financial advisor to assess strategic alternatives, including potential acquisitions or mergers, following the pause in CAR-T asset development[164]. - The company has entered into research collaborations with leading academic institutions to acquire rights to novel technologies and programs[152]. Program Developments and Changes - The company announced a pause in the development of its allogeneic CAR T cell programs, including ATA3219 and ATA3431, and has completed nearly all wind-down activities for these programs[148]. - The FDA lifted the clinical hold on the ATA3219 program in May 2025 after compliance issues were addressed[166]. - The company returned rights to the ATA188 and EBV Vaccine programs to QIMR in May 2025, and discontinued other programs[168]. - Manufacturing responsibilities for tab-cel were transferred to Pierre Fabre as of March 31, 2025, following an amendment to the A&R Commercialization Agreement[170]. - The Fujifilm Master Services and Supply Agreement was assigned to Pierre Fabre as part of the transition of manufacturing responsibility for Tab-cel[153]. Risks and Future Considerations - The company anticipates no material impact from the recent U.S. corporate tax legislation changes on its business operations[162]. - No material changes to interest rate risk, market risk, and foreign currency exchange rate risk disclosures during the nine months ended September 30, 2025[212]. - The company is subject to the timing of proceeds from the A&R Commercialization Agreement and the HCRx Agreement[212]. - Future commercialization, collaboration, licensing, and partnering arrangements may impact financial performance[212]. - The company may incur costs related to licensing, filing, prosecution, maintenance, defense, and enforcement of patents[212]. - The extent of in-licensing or acquisition of other products and technologies will influence growth strategies[212]. - Timing of qualification for partner's CMOs' manufacturing facilities is critical for operational success[212].

Financial Performance - Atara reported total revenues of $3.5 million for Q3 2025, a decrease of 91.3% compared to $40.2 million in Q3 2024[7] - The net loss for Q3 2025 was $4.3 million, or $0.32 per share, significantly improved from a net loss of $21.9 million, or $2.93 per share, in Q3 2024[7] - Total costs and operating expenses for Q3 2025 were $7.0 million, down from $61.9 million in Q3 2024, marking a decrease of 88.7%[15] Cash and Investments - Cash, cash equivalents, and short-term investments totaled $13.7 million as of September 30, 2025, down from $22.3 million as of June 30, 2025[7] - Atara's accumulated deficit as of September 30, 2025, was $2.02 billion, compared to $2.05 billion at the end of 2024[13] Research and Development - Research and development expenses decreased to $2.9 million in Q3 2025 from $43.9 million in Q3 2024, reflecting a year-over-year reduction of 93.4%[7] - The company anticipates a full-year 2025 operating expense reduction of at least 60% compared to 2024 due to the transition of tab-cel activities to Pierre Fabre[11] Milestones and Future Expectations - Atara expects to receive a $40 million milestone payment from Pierre Fabre Laboratories contingent upon FDA approval of the tab-cel BLA[4] - The FDA has set a PDUFA target action date of January 10, 2026, for the tab-cel BLA, which has been granted Priority Review[3] - The company completed the transfer of substantially all tab-cel activities to Pierre Fabre Laboratories in October 2025[5]

Company Overview - Atara Biotherapeutics (ATRA) shares increased by 10% to close at $11.82, following a notable trading volume compared to typical sessions, despite a 32.2% loss over the past four weeks [1][2] Product Development - The rise in stock price is linked to growing investor optimism regarding Atara's lead product candidate, tabelecleucel (tab-cel), which is a T-cell immunotherapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) [2] - Atara has resubmitted its biologics license application for tab-cel, which is currently under priority review by the FDA, with a decision expected on January 10, 2026 [2] Financial Performance - The company is projected to report a quarterly loss of $0.83 per share, reflecting a year-over-year increase of 71.7%, while revenues are expected to be $1.29 million, down 96.8% from the same quarter last year [3] - The consensus EPS estimate for Atara has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Atara Biotherapeutics is part of the Zacks Medical - Biomedical and Genetics industry, where another company, CervoMed Inc. (CRVO), experienced a 0.7% decline in its stock price, with a return of -17.5% over the past month [4] - CervoMed's consensus EPS estimate has also remained unchanged at -$0.68, representing a 23.6% decline from the previous year [5]

Core Insights - The article discusses the Biologics License Application (BLA) for tabelecleucel, which is currently under FDA Priority Review, potentially becoming the first approved therapy in the U.S. for EBV+ PTLD with a target action date of January 10, 2026 [1][2] - Tabelecleucel is an allogeneic T-cell therapy aimed at treating patients with EBV+ PTLD, a rare and severe blood malignancy with limited treatment options and poor prognosis [1][4] Company Developments - Pierre Fabre Pharmaceuticals has taken over the BLA for tabelecleucel from Atara Biotherapeutics, assuming full responsibility for clinical development, regulatory, commercial, and manufacturing activities worldwide [1][2] - Atara Biotherapeutics will continue to support Pierre Fabre during the regulatory process [1][2] Product Information - Tabelecleucel is designed as an off-the-shelf, EBV-specific T-cell immunotherapy that targets and eliminates EBV-infected cells, with data from over 430 patients included in the BLA [3][5] - The therapy is indicated for adult and pediatric patients aged two years and older with EBV+ PTLD who have received at least one prior therapy [1][3] Market Need - EBV+ PTLD is characterized by a median survival of only 3 weeks for HCT patients and 4.1 months for SOT patients after standard care fails, highlighting the urgent need for new therapeutic options [4]

Company Overview - Atara Biotherapeutics (ATRA) shares increased by 10% to close at $14.26, with notable trading volume compared to typical sessions, and a 2.6% gain over the past four weeks [1][2] Product Development - The rise in stock price is linked to growing investor optimism regarding Atara's lead product candidate, tabelecleucel (tab-cel), a T-cell immunotherapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) [2] - Atara has resubmitted its biologics license application for tab-cel, which is currently under priority review by the FDA, with a decision expected on January 10, 2026 [2] Financial Performance - Atara is projected to report a quarterly loss of $0.83 per share, reflecting a year-over-year increase of 71.7%, while revenues are expected to be $1.29 million, down 96.8% from the same quarter last year [3] - The consensus EPS estimate for Atara has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Atara Biotherapeutics is part of the Zacks Medical - Biomedical and Genetics industry, which includes Amicus Therapeutics (FOLD), another stock in the same sector that closed 2.3% higher at $8.35 and has returned 8.5% over the past month [5] - Amicus Therapeutics has a consensus EPS estimate of $0.12 for its upcoming report, representing a year-over-year change of 20%, and also holds a Zacks Rank of 3 (Hold) [6]

Core Insights - Atara Biotherapeutics, Inc. is a biotechnology company focused on immunotherapy for serious diseases, distinguishing itself with innovative approaches and strong financial metrics [1] Financial Performance - Atara's Return on Invested Capital (ROIC) is 36.19%, significantly higher than its Weighted Average Cost of Capital (WACC) of 6.53%, resulting in a ROIC to WACC ratio of 5.54, indicating effective capital utilization and strong potential for value creation [2][6] - In contrast, G1 Therapeutics, Inc. has a negative ROIC of -17.42% and a WACC of 12.24%, leading to a ROIC to WACC ratio of -1.42, highlighting inefficiencies in capital use [3] - Allogene Therapeutics, Inc. shows a ROIC of -57.03% against a WACC of 4.85%, resulting in a ROIC to WACC ratio of -11.77, further emphasizing capital inefficiency [3] - MacroGenics, Inc. and AnaptysBio, Inc. exhibit negative ROIC to WACC ratios of -3.98 and -2.27, respectively, indicating challenges in capital management [4] - CytomX Therapeutics, Inc. has a ROIC of 30.37% and a WACC of 13.35%, resulting in a ROIC to WACC ratio of 2.27, which, while positive, is less efficient than Atara [5][6] Competitive Landscape - Atara Biotherapeutics leads its peers in capital efficiency within the biotechnology sector, showcasing a strong position compared to competitors with negative or lower ROIC to WACC ratios [5][6]