Business
Atara Biotherapeutics Announces Third Quarter 2021 Financial Results and Operational Progress
Positive Pivotal Phase 3 ALLELE Data Reinforcing the Transformative Potential of Tab-cel® to be Highlighted as Oral Presentation at Upcoming American Society
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nPositive Pivotal Phase 3 ALLELE Data Reinforcing the Transformative Potential of Tab-cel® to be Highlighted as Oral Presentation at Upcoming American Society of Hematology Meeting\n\nSignificant Tab-cel® Regulatory Progress with Imminent EU MAA Submission and Additional Clarity on FDA Requirements for BLA Submission Planned for Q2 2022\n\nATA188 Data Demonstrates Durable, Clinically Meaningful Disability Improvement and Possible Remyelination in Patients with Progressive Multiple Sclerosis\n\nCompany to Host Live Conference Call and Webcast Today at 8:30 a.m. EDT\n\n SOUTH SAN FRANCISCO, 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 third quarter 2021, recent business highlights and key catalysts over the next several months.\n\n“Atara continues to make meaningful progress across our strategic priorities and with positive data from our pivotal Phase 3 ALLELE study and imminent EU regulatory submission, we are now at an inflection point as we work to deliver tab-cel®, a potentially transformative first-in-kind therapy, to patients in need,” said Pascal Touchon, President and Chief Executive Officer of Atara. “We are equally encouraged by new data confirming our conviction for ATA188 as the first investigational therapy to reverse disability in progressive multiple sclerosis, and upcoming milestones related to our potentially best-in-class CAR T portfolio that does not require TCR or HLA gene editing.”\n\nTabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD)\n\n\nFirst presentation of new positive data from the pivotal Phase 3 ALLELE study, reinforcing the transformative potential of tab-cel, has been accepted as an oral session at the 63rd American Society of Hematology (ASH) Annual Meeting in December 2021\n\n\nTop-line data with additional patients and extended follow up confirm a strong objective response rate (ORR) and a safety profile in line with prior results, demonstrate durability of response, and will support the imminent EU Marketing Authorization Application (MAA) submission\n\n\nAn ORR, as measured by independent oncologic response adj...