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Atara Biotherapeutics Announces Second Quarter 2024 Financial Results, Operational Progress and Leadership Update
Tab-cel® U.S. BLA Accepted Under Priority Review With PDUFA Action Date of January 15, 2025 ATA3219 Lupus Nephritis and Severe Systemic Lupus Erythematosus
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nTab-cel® U.S. BLA Accepted Under Priority Review With PDUFA Action Date of January 15, 2025\n\n\nATA3219 Lupus Nephritis and Severe Systemic Lupus Erythematosus Study Initiation Expected Q4 2024; Initial Clinical Data Expected Mid-2025\n\n\nEnrolling ATA3219 Non-Hodgkin’s Lymphoma Study; Initial Clinical Data Expected Q1 2025\n\n\nEffective September 9, 2024, Pascal Touchon To Assume Role of Chairman of the Board of Directors of Atara; Cokey Nguyen, Ph.D., Currently Chief Scientific and Technical Officer, To Be Appointed President and CEO\n\n\nCash Runway Into 2027 Enables Key Pipeline Readouts\n\n\n THOUSAND OAKS, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the second quarter 2024, recent business highlights, and key upcoming milestones for 2024.\n\n\n“Building on the recent BLA acceptance with Priority Review for tab-cel, we are making significant progress with the agency towards the target action date of January 15, 2025, while supporting our partner Pierre Fabre with their U.S. launch preparation,” said Pascal Touchon, President and Chief Executive Officer of Atara. “During the quarter we continued to advance the clinical development of our lead CAR T program, ATA3219, and remain on track to deliver key value creating milestones within the next 12 months. This is highlighted by initial data from our non-Hodgkin’s lymphoma study anticipated in the first quarter of 2025, which we believe will provide a read-through for ATA3219’s potential in autoimmune disease. On that front, we plan to initiate our ATA3219 Systemic Lupus Erythematosus trial in the fourth quarter, including the cohort without lymphodepletion, with initial data expected in mid-2025.”\n\n\nDr. Touchon continued, “Following the landmark milestone of the world’s first-ever approval of an allogeneic T-cell therapy and with the potential first U.S. approval approaching, we are advancing our differentiated allogeneic CAR-T programs into the clinic. With the Company in a strong position, I have decided to move into the role of Chairman for personal reasons to dedicate more time to my family. I look forward to havi...