Core Viewpoint - Atara Biotherapeutics is under investigation for potential securities fraud and unlawful business practices following significant stock price declines due to regulatory issues with its drug application and clinical trials [1][2][3]. Group 1: Regulatory Issues - On January 16, 2025, Atara received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for EBVALLO, leading to a stock price drop of $6.59 per share, or 50.08%, closing at $6.57 per share [2]. - On January 21, 2025, the FDA placed a clinical hold on Atara's active Investigational New Drug (IND) applications due to compliance issues identified during the pre-license inspection, resulting in a further stock price decline of $0.52 per share, or 7.91%, closing at $6.05 per share [3]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of Atara investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

Core Viewpoint - Atara Biotherapeutics is under investigation for potential securities fraud following a significant decline in stock price and operational setbacks related to FDA responses and workforce reductions [1][2][3]. Company Developments - On January 16, 2025, Atara Biotherapeutics received a Complete Response Letter (CRL) from the FDA regarding its EBVALLO treatment, which was related to manufacturing concerns at a third-party facility [2]. - The FDA also placed a clinical hold on Atara's active Investigational New Drug applications, affecting both EBVALLO and the allogeneic CD19 CAR T therapy ATA3219, leading to a suspension of new patient enrollments [2]. - Following the CRL, Atara's stock price fell by $4.82, closing at $7.62, marking a 39% decline [3]. - On January 27, 2025, Atara announced plans to cut 50% of its workforce by June 2025 as part of its response to the ongoing challenges [3]. Legal and Regulatory Context - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of Atara's investors regarding potential securities fraud by the company and its officers [1]. - The firm has a strong reputation in handling securities class actions and derivative litigation across various jurisdictions [4].

Core Viewpoint - Atara Biotherapeutics is under investigation for potential securities fraud following a significant setback with the FDA regarding its EBVALLO treatment, which has led to a substantial decline in stock price and workforce reduction [1][2][3]. Company Developments - On January 16, 2025, Atara Biotherapeutics received a Complete Response Letter (CRL) from the FDA for its EBVALLO treatment, which is intended for patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease [2]. - The CRL was related to observations from a standard pre-license inspection of a third-party manufacturing facility, leading to a clinical hold on Atara's Investigational New Drug applications, including the allogeneic CD19 CAR T therapy ATA3219 [2]. - Following the FDA's decision, Atara's stock price fell by $4.82 per share, closing at $7.62, marking a 39% decline [3]. - The company announced plans to cut 50% of its workforce by June 2025 in response to these challenges [3]. Legal and Regulatory Context - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of Atara's investors regarding potential securities fraud by the company and its officers or directors [1].

Group 1 - The Schall Law Firm is investigating claims on behalf of investors of Atara Biotherapeutics, Inc. for potential violations of securities laws [1] - The investigation centers on whether Atara made false or misleading statements or failed to disclose important information to investors [2] - Atara received a Complete Response Letter (CRL) from the FDA regarding its EBVALLO Biologics License Application, which is related to a third-party manufacturing facility inspection [2] Group 2 - The CRL pertains to the treatment for adult and pediatric patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease who have undergone at least one prior therapy [2]

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 issued a Complete Response Letter for its product EBVALLO [1][2]. Group 1: Company Overview - Atara Biotherapeutics, Inc. is a biopharmaceutical company focused on developing therapies for patients with serious diseases, including those related to Epstein-Barr virus [2]. - The company’s stock experienced a dramatic decline of 40.50% on January 16, 2025, after the announcement of the FDA's Complete Response Letter regarding its Biologics License Application for EBVALLO [2]. Group 2: Regulatory and Legal Context - The Complete Response Letter from the FDA was related to observations from a standard pre-license inspection of a third-party manufacturing facility for EBVALLO, indicating potential issues in the manufacturing process [2]. - Pomerantz LLP, a firm specializing in corporate and securities class litigation, is leading the investigation into Atara's practices, highlighting the firm's long history in fighting for victims of securities fraud [3].

On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s ATRA active Investigational New Drug (IND) applications.These INDs include the EBVALLO (tabelecleucel) program for patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, a CAR-T therapy for non-Hodgkin’s lymphoma and systemic lupus erythematosus.Specifically, identified subjects currently enrolled in the cli ...

Group 1 - The article discusses an ongoing investigation into Atara Biotherapeutics, Inc. regarding potential violations of securities laws, which may impact investor confidence and stock performance [1] - The investigation is being conducted by Levi & Korsinsky, a law firm that specializes in securities class action lawsuits, indicating the seriousness of the allegations against Atara Biotherapeutics [1] - Investors are being reminded to stay informed about the developments of the investigation, as it could lead to significant legal and financial implications for the company [1]

FDA CRL Impact on Atara Biotherapeutics - Shares of Atara Biotherapeutics (ATRA) plunged 40.5% after the FDA issued a complete response letter (CRL) against the company's biologics license application (BLA) for tabelecleucel (tab-cel) [1] - The CRL was linked to observations from a routine pre-license inspection of a third-party manufacturing facility, with no issues raised regarding manufacturing process, clinical efficacy, or safety data [3] - The FDA did not request additional clinical studies to support Ebvallo's approval [3] Ebvallo's Market and Clinical Data - Tab-cel, marketed as Ebvallo in the EU, is a novel T-cell immunotherapy for EBV+ PTLD, a rare hematologic malignancy with high mortality rates [2] - The BLA submission was based on the pivotal phase III ALLELE study, which showed a statistically significant 50% objective response rate in EBV+ PTLD patients [4] Financial and Operational Implications - The CRL has delayed Ebvallo's U.S. market entry, resulting in lost revenue potential [7] - Atara is eligible for a $60 million milestone payment from Pierre Fabre upon FDA approval, which has also been delayed, impacting operational funding [8] - The company reported preliminary cash, cash equivalents, and short-term investments of approximately $43 million as of Dec 31, 2024 [9] Strategic Alternatives and Funding - Atara is exploring strategic alternatives, including acquisition, merger, reverse merger, or sale of assets, to advance its CAR-T assets [11] - The company has signed a non-binding term sheet with Redmile Group for up to $15 million in equity funding to support Ebvallo BLA approval efforts [10] - If additional funding is not secured by Q1 2025, Atara plans to halt all CAR-T activities and focus solely on Ebvallo's approval [10] Industry Comparison - In the past three months, Atara shares have lost 16.8%, compared to the industry's 12.2% decline [2] - Castle Biosciences (CSTL), CytomX Therapeutics (CTMX), and BioMarin Pharmaceutical (BMRN) are better-ranked stocks in the sector, each sporting a Zacks Rank 1 (Strong Buy) [12] - Castle Biosciences' shares have plunged 23.2% in the past three months, while CytomX Therapeutics and BioMarin Pharmaceutical have lost 28.2% and 12.6%, respectively [13][14][15]

Financial Position - Atara Biotherapeutics reported cash, cash equivalents, and short-term investments as of December 31, 2024, but specific figures were not disclosed in the preliminary estimate[6] Product Update - The company provided a regulatory and business update on its product EBVALLO™ (tabeleucel) on January 16, 2025[7]

Atara Biotherapeutics (ATRA) is a nimble allogeneic T cell immunotherapy company with several near-term catalysts. This Zacks Rank #2 (Buy) company boasts a pipeline of differentiated therapies across a range of oncology and autoimmune indications from its proven EBV T cell platform.FDA Decision on ATRA's Tab-cel Expected Next WeekThe company’s biologics license application (BLA) seeking approval for its lead product candidate, tabelecleucel (tab-cel), in the United States is under priority review with the ...