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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.
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.
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 Stifel 2024 Healthcare Conference. Cokey Nguyen, Ph.D., President and CEO, will engage in a fireside chat on November 18, 2024 at 6:10 a.m. PST / 9:10 a.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 after the event.
Atara Biotherapeutics (ATRA) reported Q3 2024 financial results and operational progress. The company's tab-cel® BLA is on track with a PDUFA date of January 15, 2025. Total revenues were $40.2 million, up from $2.1 million in Q3 2023. Net loss was $21.9 million ($2.93 per share). Cash position was $67.2 million as of September 30, 2024.
The company dosed its first patient in the ATA3219 Non-Hodgkin's Lymphoma study, with initial data expected Q1 2025. Atara expects to initiate studies for Lupus Nephritis and Extrarenal Systemic Lupus Erythematosus by year-end. The company projects its cash runway into 2027, supported by potential milestone payments and operational efficiencies.
Atara Biotherapeutics (Nasdaq: ATRA), a company specializing in T-cell immunotherapy and developing treatments for cancer and autoimmune diseases using its allogeneic Epstein-Barr virus (EBV) T-cell platform, has scheduled the release of its third quarter 2024 financial results. The results will be announced after market close on Tuesday, November 12, 2024.
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, has reported the grant of 3,500 restricted stock units of its common stock to a newly hired employee. This award was approved by the Compensation Committee of Atara's Board of Directors and granted under the Atara Biotherapeutics, Inc. 2018 Inducement Plan, with a grant date of October 1, 2024.
The restricted stock units vest over four years, with 25 percent vesting on the first quarterly vesting date after the first anniversary of the vesting commencement date. The remainder vests in 12 approximately equal quarterly installments over the following three years, subject to continuous employment. This grant was made in accordance with Nasdaq Listing Rule 5635(c)(4) as an inducement material to the new employee entering into employment with Atara.
Atara Biotherapeutics (Nasdaq: ATRA), a leader in T-cell immunotherapy, has granted 3,700 restricted stock units to a newly hired employee. This inducement grant, approved by the Compensation Committee and made under the company's 2018 Inducement Plan, is in accordance with Nasdaq Listing Rule 5635(c)(4). The grant date is September 3, 2024.
The restricted stock units have a four-year vesting schedule: 25% vests on the first quarterly vesting date after the first anniversary, with the remaining 75% vesting in 12 approximately equal quarterly installments over the following three years. Vesting is subject to continuous employment with Atara.
Atara Biotherapeutics (Nasdaq: ATRA), a leader in T-cell immunotherapy, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's Executive Vice President and Chief Scientific & Technical Officer, Cokey Nguyen, Ph.D., will present on Monday, September 9, 2024, at 6:30 a.m. PDT / 9:30 a.m. EDT.
Atara specializes in developing transformative therapies for patients with cancer and autoimmune diseases using its novel allogeneic Epstein-Barr virus (EBV) T-cell platform. Investors and interested parties can access a live webcast of the presentation through the Investors and Media section of atarabio.com. An archived replay will be available on the company's website for 30 days following the live presentation.