On March 12, 2026 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, reported 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.

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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 and Chief Executive Officer of Atara. "We anticipate providing a regulatory update in the second quarter."

(Press release, Atara Biotherapeutics, MAR 12, 2026, View Source [SID1234663486])