Atara Biotherapeutics: Humihingi ang Kasosyo ng FDA Type A Meeting tungkol sa tab-cel CRL

Isinumite ng Pierre Fabre Pharmaceuticals ang kahilingan para sa Type A meeting at briefing book sa FDA na tumutugon sa CRL noong Enero 9, 2026 para sa tab-cel BLA. Ang pagsusumite ay nagbibigay ng karagdagang konteksto sa pag-aaral ng ALLELE kasama ang na-update na datos ng bisa at sumusuportang datos para sa posibleng muling pagsusumite.

Mahahalagang fact

Na-file: Mar 3, 2026, 01:30 PM
Kaganapan: Iba pa
Direksyon: Neutral
Kumpanya: ATRAAtara Biotherapeutics, Inc
Asset: tabelecleucel
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 d121575dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel THOUSAND OAKS, California —(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 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-contro

SEC 8-K