Atara Biotherapeutics, Inc. is an allogeneic T-cell immunotherapy company, which engages in the development of transformative therapies for patients with serious diseases including solid tumors, hematologic cancers, and autoimmune diseases. It also delivers off-the-shelf treatments to patients with high unmet medical need. Its product pipeline includes Tab-cel, ATA188, ATA2271/ATA3271, and ATA3219. The company was founded by Isaac E. Ciechanover on August 22, 2012 and is headquartered in Thousand Oaks, CA.
相关临床试验
20
11 进行中
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成立时间
2012
进行中（未招募）
11
55.0%
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- Mesoblast Limited has appointed Dr. Teresa Montagut as Head of Clinical Development and Medical Affairs to lead the company's medical affairs organization and foster clinical collaborations for expanding cell therapy programs. - Dr. Montagut brings extensive pharmaceutical development experience from Regeneron, Novartis, Genentech, and Atara Biotherapeutics, with expertise in cancer immunotherapy and investigator-initiated trials. - The appointment aims to unlock value in Mesoblast's cell therapy programs for new pediatric and adult inflammatory conditions, building on the success of FDA-approved Ryoncil for steroid-refractory acute graft versus host disease. - Dr. Montagut will work to expand indications for Ryoncil and advance the company's pipeline of transformative cellular therapies including rexlemestrocel-L for heart failure and chronic low back pain.
- The FDA declined to approve Atara Biotherapeutics' CAR-T cell therapy tabelecleucel for treating EBV+ PTLD, a rare and often fatal blood cancer affecting approximately 500 U.S. patients annually. - Internal FDA reviewers had previously recommended the therapy for approval before the agency's complete response letter cited inadequate clinical trial evidence and design flaws. - The rejection represents a significant setback for patients with no approved treatment options, as the therapy had already gained European approval under the brand name Ebvallo in 2022. - Former FDA employees suggest the reversal may be linked to changes in agency leadership, highlighting potential shifts in regulatory decision-making processes.
- Atara Biotherapeutics faces a pivotal FDA decision on January 10, 2026, for Tab-cel, a potential first-in-class treatment for EBV+ PTLD with no currently approved alternatives in the United States. - The company has implemented its third workforce reduction this year, cutting 29% of remaining staff to just 15 employees while reducing operating expenses by at least 60% through partnership with Pierre Fabre Laboratories. - A successful FDA approval would trigger a $40 million milestone payment from Pierre Fabre and position Atara to receive double-digit tiered royalties on net sales. - Despite financial challenges with $13.7 million in cash as of September 2025, the company's stock has gained 8.4% over two weeks, trading at $16.83 with increased volume ahead of the regulatory decision.
- Atara Biotherapeutics appointed Greg Ciongoli as Board Chair following strategic departures of three directors to align with the company's reduced size and streamlined operations. - The company achieved positive net income of $2.4 million in Q2 2025 after implementing aggressive cost-cutting measures including a 30% workforce reduction and transferring manufacturing to Pierre Fabre Laboratories. - With the FDA accepting the resubmitted BLA for tabelecleucel in July 2025 and a target action date of January 2026, Atara stands to receive a $40 million milestone payment upon approval. - The company has reduced 2025 operating expenses by at least 60% compared to 2024 while maintaining $22.3 million in cash reserves as of June 30, 2025.
- DelveInsight's 2025 assessment reveals 15+ companies are developing over 20 cytomegalovirus (CMV) infection treatment therapies across various clinical development phases. - Recent clinical milestones include Kamada's post-marketing research initiative for CYTOGAM, ACTG's encouraging HIV-CMV study results, and Fortress Biotech's Phase 2 trial initiation for Triplex vaccine. - The CMV pipeline encompasses diverse therapeutic approaches including mRNA vaccines, T-cell therapies, immune globulins, and antiviral compounds from companies like Moderna, Merck Sharp & Dohme, and Chimerix. - Market growth is driven by increasing CMV prevalence and research activities, though high treatment costs and healthcare infrastructure limitations present ongoing challenges.
- ImmunityBio received an FDA "refusal to file" letter for its application to expand Anktiva's use in bladder cancer patients, causing a 25% stock plunge and prompting calls for agency clarification. - The rejection comes despite Anktiva's approval last year for a related subset of bladder cancer patients, with ImmunityBio's founder Patrick Soon-Shiong citing "confounding inconsistency" in the FDA's decision-making process. - In contrast, Atara Biotherapeutics received positive news as the FDA lifted its clinical hold on blood cancer drug Ebvallo and scheduled discussions for resubmission, driving a 6% stock increase.
- Atara Biotherapeutics has priced a $16 million offering of common stock and pre-funded warrants to institutional investors including Adiumentum Capital Management and EcoR1 Capital. - The proceeds will primarily fund ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, a T-cell immunotherapy leveraging Atara's allogeneic EBV T-cell platform. - The offering, expected to close around May 16, 2025, includes 834,237 shares at $6.61 per share and pre-funded warrants for 1,587,108 shares at $6.6099 per warrant.
- The FDA issued a warning letter to Sanofi, citing significant deviations from CGMP standards at its Genzyme facility, potentially leading to regulatory actions. - Atara Biotherapeutics faces a clinical hold on its IND applications, including Ebvallo and ATA3219, due to GMP compliance issues at a third-party manufacturing site. - Atara Biotherapeutics is collaborating with the FDA to address the issues and aims to submit the necessary data for the release of the clinical hold, prioritizing patient safety. - Sanofi's partnership with Scribe Therapeutics reached a milestone, potentially earning Scribe over $1.2 billion, while Atara's Ebvallo received EMA clearance for testing at a FUJIFILM facility.
- Atara Biotherapeutics faces an FDA clinical hold on ATA3219 and EBVALLO due to manufacturing issues, delaying product sales and increasing perceived risk. - The company's need for additional financing to support its key programs is crucial, but uncertainties around resolving the clinical hold complicate matters. - Recent workforce reductions, affecting about half of its employees, reflect ongoing challenges following the FDA's Complete Response Letter for EBVALLO. - Atara is exploring strategic options, including potential mergers or acquisitions, to secure funding amidst regulatory and manufacturing challenges.
- The FDA has approved sotorasib in combination with panitumumab for treating KRAS G12C-mutated metastatic colorectal cancer in adults who have received specific prior chemotherapy regimens. - A new approval for acalabrutinib combined with bendamustine and rituximab has been granted for previously untreated mantle cell lymphoma patients. - Four cancer drugs including palbociclib, enzalutamide, pomalidomide, and acalabrutinib have been selected for Medicare's next round of drug price negotiations.
