Business
Atara Biotherapeutics Announces First Quarter 2023 Financial Results and Operational Progress
First Patients Treated in Europe with EBVALLOTM Following Transfer of EC Marketing Authorization to Pierre Fabre; Discussions with FDA Progressing ATA188
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nFirst Patients Treated in Europe with EBVALLOTM Following Transfer of EC Marketing Authorization to Pierre Fabre; Discussions with FDA Progressing\n\n\nATA188 Phase 2 EMBOLD Study Primary Data Readout On-Track for October 2023\n\n\nATA3219 IND Filing Anticipated End of Q2 2023\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 first quarter 2023, recent business highlights and key upcoming catalysts.\n\n\n“We are entering an important period of potential value-generating milestones for our prioritized pipeline assets and continue to have productive dialogue and senior level engagement with FDA regarding tab-cel,” said Pascal Touchon, President and Chief Executive Officer of Atara. “In parallel, we continue to identify operational efficiencies and reduce cash burn with the goal of further extending our cash runway to best position Atara for future success.”\n\n\nTabelecleucel (tab-cel® or EBVALLOTM) for Post-Transplant Lymphoproliferative Disease (PTLD)\n\n\n\nFollowing a recent meeting with FDA on chemistry, manufacturing, and controls (CMC) matters, Atara and the FDA agreed to hold a subsequent meeting, anticipated in Q2, to discuss additional details requested by the FDA on CMC aspects related to a potential biologics license application (BLA) submission for tab-cel. We expect to provide an update on our plans for a BLA submission for tab-cel at our next earnings release\n\n\n\nFollowing the successful transfer of the European Commission (EC) Marketing Authorization of EBVALLO to Pierre Fabre, the first patients have received treatment. Pierre Fabre is progressively launching EBVALLO on a country-by-country basis\n\n\n\nAtara is investigating label expansion opportunities with its ongoing Phase 2 multi-cohort study with initial data expected in Q4 2023\n\n\n\nAtara is engaged in discussions with potential U.S. commercialization partners\n\n\n\nATA188 for Progressive Multiple Sclerosis (MS)\n\n\n\nThe primary analysis data read out for the Phase 2 EMBOLD study is on track for October 2023\n\n\n\nATA3219: CD19 Program for B-Cell Malignancies\n\n\n\nAtara is...