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Overview of Atara Biotherapeutapeutics Inc
Atara Biotherapeutics Inc (Symbol: ATRA) is a U.S.-based biotherapeutics company dedicated to developing innovative therapies aimed at transforming the treatment landscape for patients suffering from serious diseases. With a strong focus on immunotherapy, cellular therapy, and transformative therapeutic solutions, Atara Biotherapeutics leverages cutting‐edge research into activin, myostatin and other critical growth factors to address complex underlying mechanisms of diseases such as solid tumors, hematologic cancers, and autoimmune disorders.
Core Business and Operational Focus
Atara Biotherapeutics operates in the competitive U.S. healthcare sector with a single, integrated operating segment that is focused entirely on therapeutic development. The company drives its research and development efforts by exploring the intersection of cellular therapies and T-cell engineering. This strategy underscores its commitment to harnessing the body’s own defense mechanisms to create targeted, potent treatments that aim to disrupt disease progression. The company’s approach is built on over a decade of research and clinical exploration, resulting in a pipeline of innovative product candidates that seek to redefine current therapeutic standards.
Innovative Product Candidates and Research Direction
The company has developed multiple innovative product candidates designed to address critical disease pathways. Its portfolio includes T-cell based therapies and advanced platforms such as the CAR T Platform, which highlights the company’s specialization in cellular therapy. In addition to its internally developed candidates, Atara Biotherapeutics has also engaged in strategic collaborations that bolster its research capacity and clinical insights. These collaborations enable the sharing of specialized expertise and resources, further fortifying its development of safe and effective therapeutic solutions.
Scientific Approach and Industry Collaboration
Atara Biotherapeutics’ research is inspired by pioneering discoveries in growth factor biology, which inform its approach to reversing or halting pathological processes underlying various diseases. The company’s commitment to scientific rigor is reflected in its methodical evaluation of molecular targets, including activin and myostatin, that have significant implications for patient care. Collaborations with renowned institutions, such as partnerships with leading cancer centers, play a vital role in validating and accelerating the development of its therapeutic candidates. This synergistic approach fosters an environment of innovation and precision medicine.
Market Position and Competitive Landscape
Positioned within the biotech and healthcare sectors, Atara Biotherapeutics faces both significant opportunities and challenges characteristic of drug development companies. Its niche focus on T-cell and cellular therapies places it among a competitive group of innovators striving to address critical unmet medical needs. What sets Atara apart is the integration of robust scientific research with strategic collaborations and a focused therapeutic pipeline. By concentrating on areas where traditional treatments have reached their limits, the company reinforces its commitment to offering alternative, mechanism-driven therapeutic options that are supported by extensive preclinical and clinical research.
Expertise and Trustworthiness in Therapeutic Development
The depth of experience at Atara Biotherapeutics is demonstrated through its comprehensive approach to treatment development. The company applies advanced scientific methods and leverages ongoing research to refine its product candidates continuously. Its clinical development strategies emphasize safety, efficacy, and reliable delivery of therapeutic benefits to patients. This dedication to scientific excellence, combined with collaborations with esteemed medical institutions, enhances its credibility and positions the company as a knowledgeable entity within the biotherapeutics space.
Key Business Segments and Value Proposition
While the company's operations are centralized within a single reportable segment, its focus encompasses the entire spectrum of therapeutic innovation—from early-stage research to clinical development. This unified operational focus allows Atara Biotherapeutics to efficiently coordinate its research, streamline development processes, and pivot when necessary based on scientific insights. The primary value proposition of the company lies in its ability to translate complex biological insights into practical therapies, thereby offering new hope and treatment avenues for patients facing severe and often life-threatening conditions.
Conclusion
Atara Biotherapeutics Inc presents a comprehensive example of modern biotherapeutic innovation. By maintaining a steadfast focus on cellular and T-cell therapies along with robust scientific and clinical collaborations, the company is systematically addressing some of the most challenging areas in healthcare. Its endeavors are underpinned by scientific expertise, rigorous methodology, and a commitment to developing therapies that are both transformative and rooted in deep molecular insights, reaffirming its position as a significant research-driven entity in the biotherapeutics industry.
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.
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.