Business
Atara Biotherapeutics Announces Third Quarter 2022 Financial Results and Operational Progress
EbvalloTM Positioned to be the First Allogeneic T-Cell Therapy Ever Approved Following CHMP Positive Opinion New ATA188 Biomarker Imaging Data Show Less
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nEbvalloTM Positioned to be the First Allogeneic T-Cell Therapy Ever Approved Following CHMP Positive Opinion\n\nNew ATA188 Biomarker Imaging Data Show Less Brain Atrophy and Possible Remyelination in Patients Achieving Confirmed Disability Improvement in Progressive MS\n\nPhase 1 Study of ATA2271 Enrollment Resumed\n\nConference Call and Webcast Today at 1:30 p.m. PST / 4:30 p.m. EST\n\n THOUSAND OAKS, 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 third quarter 2022, recent business highlights, and key upcoming catalysts.\n\n“Receiving the positive CHMP opinion for EbvalloTM (tabelecleucel) positions our product to be the first-ever approved allogeneic off-the-shelf T-cell therapy and provides important validation for our EBV T-cell platform and portfolio,” said Pascal Touchon, President and Chief Executive Officer of Atara. “We continue to generate positive forward momentum across our programs, punctuated by compelling new biomarker imaging and long-term clinical data that further reinforce our belief in the transformative potential of ATA188.”\n\nTabelecleucel (tab-cel® or EbvalloTM) for EBV-Associated Ultra-Rare Cancers\n\n\nAtara received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for EbvalloTM as a monotherapy for 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)\n\n\nWith CHMP positive opinion, the European Commission’s (EC) potential approval of the EbvalloTM Marketing Authorization Application (MAA) is expected by the end of 2022\n\n\n\n\nAtara recently held a meeting with the U.S. Food and Drug Administration (FDA) that culminated in clear guidance and agreement on specific chemistry, manufacturing, and controls (CMC) Module 3 requirements for potential biologics license application (BLA) submission\n\n\nA new meeting is planned with the FDA to discuss and potentially align on clinical data package requirements to prepare for a pre-BLA meeting\n\n\n\n\nAtara will present updated inter...