Atara: FDA Type A meeting tungkol sa CRL ng tab-cel; tiyak na ang landas ng resubmission

The FDA agreed that a single-arm study with a pre-specified historical control can serve as an adequate and well-controlled study to support resubmission of the tab-cel BLA. PFP plans to submit an updated ALLELE dataset with additional patients and longer follow-up plus supportive data. Atara expects a further regulatory update in Q3.

Mahahalagang fact

Na-file: May 7, 2026, 12:10 PM
Kaganapan: Complete response letter
Direksyon: Neutral
Kumpanya: ATRAAtara Biotherapeutics, Inc
Asset: tabelecleucel
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Ene 10, 2026 · Complete response letter

Sipi mula sa source

EX-99.1 2 atra-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel THOUSAND OAKS, Calif.--(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 provided an update following the recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals, Inc. (PFP). PFP, with Atara’s support, had a productive meeting with the FDA and discussed a potential path forward to

SEC 8-K