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0.0316139767054908 -0.0232945091514144 0.00166389351081527 0.0482529118136439 0.0948419301164724 0.0715474209650582 0.0598835274542429 0.0449251247920132
Stock impact report

Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel

Atara Biotherapeutics, Inc. (ATRA) 
Last atara biotherapeutics, inc. earnings: 2/27 07:30 am Check Earnings Report
US:NASDAQ Investor Relations: investors.atarabio.com/investor-relations
Company Research Source: Business Wire
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Atara 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 announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals.Pierre Fabre Pharmaceuticals, with Atara’s support, will meet with the agency to collaboratively address the points from the CRL and enable a resubmission with the additional efficacy data that has been collected since the original BLA submission.“We are pleased that the FDA has granted a Type A Meeting to our partner, Pierre Fabre, and hope to gain clarity on a path forward for re-submission of the tab-cel BLA,” said Cokey Nguyen, President Show less Read more
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