Atara Biotherapeutics: Mitra Meminta Pertemuan Tipe A FDA Terkait CRL tab-cel

Pierre Fabre Pharmaceuticals mengajukan permintaan pertemuan Tipe A dan buku pengarahan kepada FDA untuk menanggapi CRL tab-cel BLA tertanggal 9 Januari 2026. Pengajuan ini memberikan konteks tambahan mengenai studi ALLELE serta data efikasi dan data pendukung yang diperbarui untuk potensi pengajuan ulang.

Fakta utama

Diajukan: 3 Mar 2026, 13.30
Peristiwa: Lainnya
Arah: Netral
Perusahaan: ATRAAtara Biotherapeutics, Inc
Aset: tabelecleucel
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

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