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Atara Biotherapeutics Announces Second Quarter 2020 Financial Results and Operational Progress
– Company to host conference call today at 4:30 p.m. EDT – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\n– Company to host conference call today at 4:30 p.m. EDT –\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 severe diseases including solid tumors, hematologic cancers and autoimmune disease, today reported financial results for the second quarter ended June 30, 2020 and recent business highlights.\n\n\n“I am proud of the continued tremendous progress made by Atara’s team in delivering on our strategic priorities and on our mission to bring transformative therapies to patients with severe diseases,” said Pascal Touchon, President and Chief Executive Officer of Atara. “We remain on track to initiate a BLA submission for tab-cel® for patients with EBV+ PTLD by the end of 2020, despite the COVID-19 outbreak. During the quarter we also reported positive ATA188 clinical data in progressive multiple sclerosis at EAN, successfully completed a follow-on financing, made key executive and board hires, and progressed our CAR T programs closer to the clinic.”\n\n\nRecent Highlights and Anticipated Upcoming Milestones\n\n\nTab-cel® (tabelecleucel)\n\n\nPost-transplant lymphoproliferative disease (PTLD)\n\n\n\nAtara remains on track to initiate a biologics license application (BLA) submission for patients with EBV+ PTLD by the end of 2020.\n\n\nThe Company continues to advance development of tab-cel® in Phase 3 for patients with EBV+ PTLD, for which the Company has obtained Breakthrough Therapy Designation (BTD) in the United States (U.S.) and PRIority MEdicines (PRIME) designation in the European Union (EU).\n\n\nThe Company plans to conduct an interim analysis of the tab-cel® Phase 3 study in the third quarter of 2020 and then discuss the totality of tab-cel® data with the U.S. Food and Drug Administration (FDA) in a pre-BLA meeting prior to initiating the BLA submission.\n\n\nAtara is in active discussions with the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) regarding a Pediatric Investigation Plan (PIP). Following discussion with the PRIME team and after EMA approval of the PIP, Atara plans to submit an EU marketing authorization application (MAA) for patients with EBV+ PTLD in 2021.\n\n\nIn the U.S., Europe and Australia, more th...