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.
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 (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) reported its Q4 and full year 2024 financial results, facing significant operational changes. The company received a Complete Response Letter (CRL) from FDA for EBVALLO in January 2025, leading to a clinical hold due to third-party manufacturing facility issues.
Key financial metrics include:
- Q4 2024 net loss of $12.7 million ($1.19 per share)
- Full year 2024 net loss of $85.4 million ($11.41 per share)
- Cash position of $42.5 million as of December 31, 2024
The company implemented a 50% workforce reduction and paused its CAR-T programs (ATA3219 and ATA3431) to preserve resources. Atara secured potential funding of up to $15 million through an equity line of credit with Redmile Group and is exploring strategic alternatives including potential merger or acquisition options.
Atara Biotherapeutics (Nasdaq: ATRA), a leader in T-cell immunotherapy, has granted 1,350 restricted stock units to one newly hired employee. The grant was approved by the company's Compensation Committee under the 2018 Inducement Plan, effective February 3, 2025. The stock units will vest over a four-year period, with 25% vesting after the first anniversary and the remaining portions vesting in 12 quarterly installments over the following three years, contingent on continuous employment. This grant was made in accordance with Nasdaq Listing Rule 5635(c)(4) as an inducement for employment.
Atara Biotherapeutics (ATRA) announced that the FDA has placed a clinical hold on its active Investigational New Drug (IND) applications for EBVALLO™ (tabelecleucel) and ATA3219 programs. The hold affects EBVALLO's treatment for EBV+ PTLD and ATA3219's therapy for non-Hodgkin's lymphoma and systemic lupus erythematosus.
The clinical hold stems from unresolved GMP compliance issues at a third-party manufacturing facility, which were previously identified in a Complete Response Letter (CRL) on January 16, 2025. While current participants showing potential clinical benefits may continue treatment, new enrollment has been paused.
The issues specifically affect one third-party facility and do not impact Atara's second manufacturer, FUJIFILM Diosynth Biotechnologies facility. Atara and FDA have agreed on necessary actions to release the holds, with FDA committing to work collaboratively for resolution.
Atara Biotherapeutics (NASDAQ: ATRA) received a Complete Response Letter (CRL) from the FDA regarding EBVALLO™ (tabelecleucel). The CRL solely relates to inspection findings at a third-party manufacturer and did not identify any issues with clinical efficacy, safety data, or manufacturing process. No new clinical trials were requested.
The company is working with Pierre Fabre Laboratories and the manufacturer to address the feedback and expects potential approval within six months of resubmission. EBVALLO, already approved in Europe, demonstrated a 50% Objective Response Rate in the pivotal ALLELE study.
Atara has secured a potential $15 million funding through an equity line of credit from Redmile Group to support BLA approval activities. The company reported approximately $43 million in cash and equivalents as of year-end 2024. Atara remains eligible for a $60 million milestone payment upon FDA approval and double-digit tiered royalties from Pierre Fabre.
Atara Biotherapeutics (Nasdaq: ATRA), a pioneer in T-cell immunotherapy focusing on EBV T-cell platform for cancer and autoimmune disease treatments, has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. Cokey Nguyen, Ph.D., President and CEO, will engage in a fireside chat on Tuesday, December 3, 2024, at 3:50 p.m. EST. The presentation will be accessible via live webcast in the Investors and Media section of atarabio.com, with a replay available for 30 days afterward.