Atara Biotherape Stock Price, News & Analysis

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.

Atara Biotherapeutics (Nasdaq: ATRA) has resubmitted its Biologics License Application (BLA) to the FDA for tabelecleucel (tab-cel®), targeting Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in patients who have received prior therapy. The resubmission addresses manufacturing facility observations from a January 2025 Complete Response Letter.

The BLA is supported by data from over 430 patients, including the pivotal ALLELE study showing a 48.8% Objective Response Rate. Upon FDA approval, Atara will receive a $40 million milestone payment from Pierre Fabre Laboratories, plus future double-digit tiered royalties on sales.

The company reports $22M in cash as of June 30, 2025, projecting runway into Q1 2026. Atara is transferring tab-cel operational activities to Pierre Fabre while maintaining BLA sponsorship.

CDR-Life has appointed Pascal Touchon, DVM, MBA to its Board of Directors. Touchon brings 40 years of international biopharmaceutical industry experience, particularly in oncology and strategic leadership. He currently serves as Chairman of Atara Biotherapeutics (NASDAQ: ATRA) and holds board positions at Ipsen, Medincell, and Catalym.

Previously, Touchon held key leadership roles at Novartis Oncology, including Global Head of Strategy and Business Development and Global Head of the Cell & Gene division, where he led the development and launch of the first FDA-approved cell and gene therapy in the US. His appointment aims to strengthen CDR-Life as it advances its M-gager® platform and pipeline of T cell engager therapeutics.

Atara Biotherapeutics (NASDAQ: ATRA), a T-cell immunotherapy company, has appointed two new members to its Board of Directors following the completion of their $16 million offering. James Huang, Founder and Managing Partner of Panacea Venture, brings 37 years of biotech experience, including leadership roles at Kleiner Perkins China, Vivo Ventures, and various pharmaceutical companies. Nachi Subramanian, currently Managing Director at Redmile Group, joins with extensive financial experience from his fourteen-year tenure at J.P. Morgan and background in Institutional Equities.

Atara Biotherapeutics (ATRA) reported Q1 2025 financial results and operational updates. The company reported net income of $38.0 million ($3.53 basic EPS), compared to a net loss of $31.8M in Q1 2024. Total revenues increased to $98.1 million, up from $27.4M YoY. Atara has transferred all manufacturing responsibilities of tabelecleucel to Pierre Fabre Laboratories and implemented significant cost-cutting measures, including an 85% workforce reduction since December 2024. The company secured $16 million in new financing through a stock and warrant offering. The FDA has lifted clinical holds on EBVALLO™ studies and granted a Type A meeting in Q2 2025 to discuss the Complete Response Letter issues. Atara expects to reduce operating expenses by 65% in 2025 and projects its cash runway to extend into Q1 2026.

Atara Biotherapeutics (NASDAQ: ATRA) has announced the pricing of an underwritten registered direct offering to select institutional investors, including Adiumentum Capital Management, EcoR1 Capital, Panacea Venture, and Redmile Group. The offering consists of 834,237 common stock shares at $6.61 per share and 1,587,108 pre-funded warrants at $6.6099 per warrant with a $0.0001 exercise price.

The offering, expected to close around May 16, 2025, aims to raise $16 million in gross proceeds. The funds will be used to support the company's biologics license application (BLA) approval process for tab-cel and general corporate purposes. TD Cowen is serving as the sole bookrunner for this offering.

Atara Biotherapeutics (NASDAQ: ATRA) announced that the FDA has lifted the clinical hold on its EBVALLO™ (tabelecleucel) program, which was imposed in January 2025 due to GMP compliance issues at a third-party manufacturing facility. The company can now resume its Phase 3 ALLELE study for EBV+ PTLD patients and Phase 2 label-expansion study. Additionally, the FDA has granted a Type A meeting to discuss addressing issues from the January 2025 Complete Response Letter (CRL) and the path forward for BLA resubmission. Atara has temporarily paused its strategic options evaluation process, which includes potential acquisition, merger, or sale considerations, pending clarity on the BLA resubmission timeline.