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Atara Biotherapeutics Announces Second Quarter 2021 Financial Results and Operational Progress
Progress with FDA on evaluating tab-cel® product comparability and new robust Phase 3 ALLELE study data Recent positive milestones with EMA provide clear
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nProgress with FDA on evaluating tab-cel® product comparability and new robust Phase 3 ALLELE study data\n\nRecent positive milestones with EMA provide clear path for EU Marketing Authorization Application submission in November 2021\n\nImportant new ATA188 magnetization transfer ratio (MTR) imaging biomarker data and updated clinical data to be presented at ECTRIMS in October \n\nCompany to Host Live Conference Call and Webcast Today at 4:30 p.m. EDT\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer 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 second quarter 2021, recent business highlights and key catalysts over the next several months.\n\n“We are very pleased with the progress achieved across all of our programs and important clinical updates across our full pipeline, which will enable us to deliver on key value drivers through the rest of this year and into 2022,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Recent tab-cel® regulatory progress and alignment with both FDA and EMA allow us to continue anticipating approvals in 2022, while exciting new ATA188 imaging data reinforces our belief in this potentially transformative therapy for patients with multiple sclerosis.”\n\nTabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD)\n\n\nAtara conducted productive meetings with the U.S. Food and Drug Administration (FDA), gaining clarity on specific next steps required for submission of the Biologics License Application (BLA)\n\n\nAlignment on key methodologies for evaluating comparability between Atara product used in the pivotal ALLELE study and the intended commercial product. Atara will provide data on substantially all lots made to date through a Type B CMC meeting to enable FDA to make a final determination on the data package to support comparability\n\n\nFDA decided it cannot make a determination of comparability between material used in non-pivotal and pivotal studies because analytical data is not available and cannot be generated for all lots manufactured at Memorial Sloan Kettering Cancer Center (MSK) and used in non-pivotal studies. Consequently, Atara pla...