NEW YORK, Jan. 27, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Atara Biotherapeutics, Inc. (“Atara” or the “Company”) (NASDAQ: ATRA).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Atara and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On Janua ...

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].

Core Insights - Several companies have experienced significant price changes due to various underlying factors, including corporate developments, industry shifts, and broader economic conditions [5] Company-Specific Summaries - Atara Biotherapeutics, Inc. (Nasdaq: ATRA) saw its price drop by approximately 54% to $6.28, down from a year-high of $19.14, potentially due to concerns over trial results, regulatory hurdles, or financial sustainability, particularly after receiving a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application for EBVALLO™ [1][6] - Nuvation Bio Inc. (NUVB-WT) experienced a nearly 47% decrease in price to $0.09, reflecting investor skepticism possibly due to challenges in its oncology-focused pipeline and a lack of recent positive news [2][6] - Lyra Therapeutics, Inc. (LYRA) witnessed a 46% drop in its price to $2.04, attributed to concerns over the clinical progress of its key product candidates or potential financial constraints impacting its research and development activities [3] - Mingteng International Corporation Inc. (Nasdaq: MTEN) saw its price fall by over 41% to $0.077, possibly related to operational challenges, market competition, or broader economic factors affecting the manufacturing sector, despite announcing an expansion of its strategic collaboration in the new energy vehicle sector [4]

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]

Core Insights - Four biotechnology stocks have surged into the top 10th percentile for momentum ranking, indicating strong technical strength and price action [1][2] Group 1: Momentum Ranking - Arrowhead Pharmaceuticals Inc. (ARWR), Assembly Biosciences Inc. (ASMB), Atara Biotherapeutics Inc. (ATRA), and Corcept Therapeutics Inc. (CORT) have shown significant momentum percentile increases, making them stand out in the competitive biotech sector [2][5] - Joining the top decile for momentum ranking means these stocks are outperforming 90% of all tracked stocks in terms of price appreciation and volatility-adjusted returns [5] Group 2: Individual Stock Performance - ARWR's momentum percentile increased from 89.87 to 93.79, with a week-on-week gain of 3.92 percentage points; the stock has risen by 66.92% year-to-date and 69.33% over the year [7] - ASMB moved from 87.58 to 93.13, posting a 5.55 percentage point increase; it is up 43.85% YTD and 62.95% over the year [7] - ATRA climbed from 88.24 to 92.76, translating to a weekly gain of 4.52 percentage points; the stock has declined 2.97% YTD but advanced 69.00% over the year [8] - CORT advanced from 88.05 to 90.50, achieving a week-on-week improvement of 2.45 percentage points; it has risen by 67.84% YTD and 81.22% over the year [8]