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Atara Biotherapeutics Announces Fourth Quarter and Full Year 2022 Financial Results and Operational Progress
Ebvallo™ EU Launch Activities Led by Pierre Fabre to Commence in Q1 2023 Discussions with FDA Progressing on Potential U.S. BLA for Tab-cel® ATA188 Phase 2
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nEbvallo™ EU Launch Activities Led by Pierre Fabre to Commence in Q1 2023\n\nDiscussions with FDA Progressing on Potential U.S. BLA for Tab-cel®\n\nATA188 Phase 2 EMBOLD Study Primary Data Readout On-Track for October 2023\n\nCash Runway Extended into Q2 2024\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 fourth quarter and full year 2022, recent business highlights and key upcoming catalysts for 2023.\n\n“Following the landmark approval of EbvalloTM in Europe, we had productive discussions with the FDA about their requirements for a tab-cel BLA. We welcome the opportunity to further discuss the topic of comparability that may advance our progress towards a BLA submission,” said Pascal Touchon, President and Chief Executive Officer of Atara. \"Meanwhile, we are on track for the results of our Phase 2 EMBOLD study this October, a key catalyst that could progress ATA188 towards becoming the first ever targeted and transformative therapy in multiple sclerosis (MS) following the landmark scientific discovery of EBV as the leading trigger of MS.”\n\nTabelecleucel (tab-cel® or EbvalloTM) for Post-Transplant Lymphoproliferative Disease (PTLD)\n\n\nAtara recently held a productive meeting with FDA on clinical aspects for a potential biologics license application (BLA) submission for tab-cel\n\n\nAtara and the FDA are expected to hold another meeting to further discuss chemistry, manufacturing, and controls (CMC) matters relating to a potential BLA for tab-cel, including aspects related to comparability that may support pooling clinical data from different process versions\n\n\nAtara expects to provide a further update in Q2 2023\n\n\n\n\nIn December 2022, Atara announced that the European Commission (EC) granted marketing authorization for the first-of-its-kind, off-the-shelf, allogeneic T-cell therapy, Ebvallo™ (tabelecleucel) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one pri...