Business
Atara Biotherapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Operational Progress
On track to complete the rolling tab-cel® BLA submission in Q3 2021 for patients with EBV+ PTLD through active and productive discussions with FDA On track
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nOn track to complete the rolling tab-cel® BLA submission in Q3 2021 for patients with EBV+ PTLD through active and productive discussions with FDA\n\nOn track with ATA188 Phase 2 RCT (randomized controlled trial) enrollment in patients with progressive forms of MS, enabling an interim analysis in H1 2022\n\nContinued progress on advancing CAR T portfolio, enabling clinical data presentation for mesothelin-targeted ATA2271 in Q4 2021 and IND submission for novel allogeneic CD19 CAR T ATA3219 in Q4 2021/Q1 2022 \n\nConference Call and Webcast Today at 4:30 p.m. EST \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 serious diseases including solid tumors, hematologic cancers and autoimmune diseases, today reported financial results for the fourth quarter and full year 2020, recent business highlights and key catalysts over the next 18 months.\n\n“Atara had a very strong year in 2020, delivering on key milestones across the Company’s three strategic priorities,” said Pascal Touchon, President and Chief Executive Officer of Atara. “We anticipate several additional key catalysts over the next 18 months, especially the completion of the tab-cel® BLA filing in Q3 2021, significant advancement on the ATA188 program - including long-term clinical data update from the Phase 1 study as well as enrollment progress in the Phase 2 RCT enabling an interim analysis, and preclinical and clinical progress on both the mesothelin and CD19 CAR T programs.”\n\nTabelecleucel (tab-cel®) for Post-transplant Lymphoproliferative Disease (PTLD)\n\n\nThe Company has completed the preclinical module 4 and is ready to initiate a rolling BLA with this module once the FDA decides on a procedural question related to how the historical non-pivotal data should be presented in the BLA submission\n\n\nAtara is making progress through active and productive discussions with FDA on the final content of the CMC module 3\n\n\nAtara is on track to complete a rolling BLA submission for patients with EBV+ PTLD with the clinical module in Q3 2021\n\n\nAtara plans to submit an EU Marketing Authorization Application (MAA) for patients with EBV+ PTLD in Q4 2021\n\n\nData from the Phase 3 ALLE...