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.
Atara Biotherapeutics (Nasdaq: ATRA) has not yet initiated the Biologics License Application (BLA) for tab-cel® (tabelecleucel), under Phase 3 development for EBV-positive post-transplant lymphoproliferative disease. The Company awaits a procedural decision from the FDA regarding historical data presentation in the BLA. Despite the delay, Atara remains on track to complete the BLA filing in Q3 2021, with an objective response rate of 50% reported in the pivotal study. Ongoing discussions with the FDA are described as constructive.
Atara Biotherapeutics, Inc. (Nasdaq: ATRA) announced a public offering of 5,102,041 shares at $24.50 each and pre-funded warrants for 2,040,816 shares at $24.4999, totaling approximately $175 million in gross proceeds. The offering is set to close on December 11, 2020, pending customary conditions. Citigroup, Evercore ISI, and Mizuho Securities serve as joint book-running managers, with an option for underwriters to purchase an additional 1,071,428 shares. The offering is conducted under a previously filed registration statement with the SEC.
Atara Biotherapeutics (Nasdaq: ATRA) has initiated a public offering of $150 million in common stock, with a potential additional $22.5 million from underwriters. The offering is subject to market conditions, and there are no guarantees regarding its completion or terms. The shares will be sold by Atara Biotherapeutics, leveraging a previously filed shelf registration statement with the SEC. Citigroup, Evercore ISI, and Mizuho Securities are acting as joint book-running managers for this offering.
Atara Biotherapeutics (Nasdaq: ATRA) announced the first preclinical evaluation of ATA3219, a novel off-the-shelf CAR T-cell therapy targeting CD19, and data from its Phase II study of tab-cel® for EBV-driven diseases. The results showcased ATA3219's potent antitumor activity and safety in preclinical models. Atara plans to submit an IND for ATA3219 in 2021 following a successful FDA meeting. Additionally, tab-cel® demonstrated high response rates in patients with life-threatening EBV viremia, with an overall survival rate of 100% at one year.
Bayer and Atara Biotherapeutics, Inc. (Nasdaq: ATRA) have entered a global license agreement for mesothelin-directed CAR T-cell therapies targeting solid tumors. This collaboration involves the development candidate ATA3271 and an autologous version, ATA2271. Atara will oversee IND-enabling studies while Bayer manages the IND submission and clinical development. Atara receives an upfront payment of $60 million and can earn up to $610 million in milestones plus royalties on net sales. This partnership aims to enhance the development of off-the-shelf CAR T-cell therapies for challenging cancer types.
Atara Biotherapeutics, a leader in T-cell immunotherapy, has announced participation in two upcoming virtual conferences. The Stifel 2020 Virtual Healthcare Conference is set for November 18, 2020, featuring a fireside chat with CEO Pascal Touchon. The Evercore ISI 3rd Annual Virtual HealthCONx Conference will take place on December 2, 2020, with chats including Pascal Touchon and Jakob Dupont, Global Head of Research and Development. Both events will be accessible via live webcasts on the company's website, with archived replays available for 14 days.
Atara Biotherapeutics (Nasdaq: ATRA) announced promising 15-month safety and efficacy data for ATA188, a treatment for progressive multiple sclerosis (MS), presented at the European Charcot Foundation's 28th Annual Meeting. In a Phase 1a study, 50% of patients showed sustained disability improvement, indicating a potential treatment effect. Atara plans to enhance its investment in the ATA188 program, expanding the randomized controlled trial to at least 64 patients and focusing on disability improvement as the primary endpoint. This treatment addresses a significant unmet need in MS.
Atara Biotherapeutics (Nasdaq: ATRA) announced the preclinical evaluation of ATA3271, an allogeneic EBV CAR T-cell therapy targeting mesothelin for solid tumors. The data, presented at the SITC 2020, demonstrate potent antitumor activity of ATA3271 in both in vitro and in vivo settings, with no evident toxicities. The therapy retained function despite high PD-L1 expression in tumor environments. Additionally, the FDA accepted an IND application for another therapy, ATA2271. These advancements signal a step forward in Atara's commitment to transformative cancer therapies.
Atara Biotherapeutics (Nasdaq: ATRA) reported its Q3 2020 financial results, revealing a net loss of $74.3 million, or $0.92 per share. Despite a cash balance of $327.2 million sufficient to fund operations into 2022, R&D expenses increased to $59.9 million due to expanding clinical activities. Notably, the interim analysis of tab-cel® for relapsed-refractory EBV+ PTLD showed a 50% objective response rate. Atara plans to submit a BLA for tab-cel® by year-end 2020 and an EU MAA in H2 2021, further advancing their allogeneic T-cell therapies.
Atara Biotherapeutics (ATRA) will release its Q3 2020 financial results on November 9, 2020, after market close. The company, known for its innovative T-cell immunotherapy, will host a conference call at 4:30 p.m. EST to discuss the results and provide a corporate update. Analysts and investors can join the call via designated phone numbers or access the live audio webcast on Atara's website. The company aims to deliver life-changing therapies for diseases like solid tumors and hematologic cancers through its EBV T-cell platform.