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Atara Biotherapeutics' Pierre Fabre Pharmaceuticals Submits Request To FDA For Type A Meeting About ALLELE Trial

Benzinga·03/03/2026 13:27:20
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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 its partner Pierre Fabre Pharmaceuticals (PFP) has submitted a request to the FDA for a Type A meeting.

Pierre Fabre Pharmaceuticals, in partnership with Atara, submitted a briefing book to the FDA addressing the points from the Complete Response Letter dated January 9, 2026, providing additional context and clarification that the ALLELE study was adequate, well-controlled, and sufficient to support the tabelecleucel (tab-cel) Biologics License Application. In addition, the briefing book includes summaries of updated, longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission.