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Perre Fabre Pharmaceuticals, Inc. Announces Transfer of Investigational New Drug Application for Tabelecleucel from Atara Biotherapeutics, Inc.
Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel from its partner, Atara Biotherapeutics, Inc. (Nasdaq: ATRA). "This announcement marks an important milestone as Pierre Fabre Laboratories assumes global responsibility for clinical development of tabelecleucel following transfer of manufacturing responsibilities earlier in the year," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals., the Pier
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program","length":124,"tagName":"p","attribs":{}},{"type":"text","content":"Enrollment is ongoing for pivotal, Phase 3 ALLELE Study (NCT03394365) investigating tabelecleucel in patients with EBV+PTLD in Solid Organ Transplant and Allogeneic Hematopoietic Cell Transplant after failure of standard therapy","length":228,"tagName":"p","attribs":{}},{"type":"text","content":"NCT04554914 also open for enrollment to patients with EBV-associated diseases","length":77,"tagName":"p","attribs":{}},{"type":"text","content":"Atara Biotherapeutics resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration on July 11","length":139,"tagName":"p","attribs":{}},{"type":"text","content":"SECAUCUS, N.J., July 15, 2025 /PRNewswire/ -- Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel from its partner, Atara Biotherapeutics, Inc. (Nasdaq: ATRA). "This announcement marks an important milestone as Pierre Fabre Laboratories assumes global responsibility for clinical development of tabelecleucel following transfer of manufacturing responsibilities earlier in the year," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals., the Pierre Fabre Laboratories pharmaceutical subsidiary in the United States. "Ongoing recruitment into the ALLELE study demonstrates our commitment to clinical research and development as we await regulatory action on the BLA resubmitted by our partner Atara." ","length":819,"tagName":"p"},{"type":"image","alt":"The mission of Pierre Fabre Pharmaceuticals (PFP) is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better. PFP is the US pharmaceutical subsidiary of Pierre Fabre Laboratories, a foundation-owned company with seven decades of impact. (PRNewsfoto/Pierre Fabre Pharmaceuticals)","displaySize":"","headline":null,"caption":"The mission of Pierre Fabre Pharmaceuticals (PFP) is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet ...