Business
Atara Biotherapeutics Announces Fourth Quarter and Full Year 2021 Financial Results and Operational Progress
Tab-cel U.S. BLA Submission Not Currently Expected for Q2 2022 as Further FDA Engagement and Alignment Required; Anticipated EU Approval On-Track for Q4 2022
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nTab-cel U.S. BLA Submission Not Currently Expected for Q2 2022 as Further FDA Engagement and Alignment Required; Anticipated EU Approval On-Track for Q4 2022 Under Accelerated Assessment\n\nATA188 Granted FDA Fast Track Designation in Both Non-Active PPMS and Non-Active SPMS with Phase 2 EMBOLD Study Interim Analysis Planned for Q2 2022\n\nEntered Long-Term Strategic Manufacturing Partnership with Fujifilm with Upfront Cash Payment of USD 100 Million\n\nConference Call and Webcast Today at 1:30 p.m. PST/ 4:30 p.m. EST\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the fourth quarter and full year 2021, recent business highlights and key upcoming catalysts for 2022.\n\n“With our EMA filing for tab-cel® and a strategic commercial collaboration with Pierre Fabre, ATA188’s FDA Fast Track designations and new data reinforcing its potential to reverse or halt disability in progressive multiple sclerosis, 2021 provided strong validation for Atara and our industry-leading allogeneic T-cell pipeline,” said Pascal Touchon, President and Chief Executive Officer of Atara. “2022, which has already delivered two landmark publications confirming EBV as the leading cause of MS in advance of our interim analysis from our ATA188 Phase 2 study, and a long-term strategic manufacturing partnership with Fujifilm, will be a critical year as we progress our strategic priorities. Although further engagement and alignment is required with FDA to determine the path forward for a BLA submission in the U.S., we anticipate a groundbreaking EU approval this year that will position tab-cel as the first ever allogeneic off-the-shelf T-cell therapy available for patients.”\n\nTabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD)\n\n\nAtara has performed extensive studies demonstrating analytical comparability between the tab-cel manufacturing process versions used for the pivotal study and that intended for commercialization\n\n\nComprehensive comparability analyses included all 74 available product lots manufactured by Atara and covered 21 key attributes associated with potency, p...