ATRA Atara Biotherapeutics Inc

$ATRA Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration https://www.businesswire.com/news/home/20261014012366/en/Atara-Biotherapeutics-Reports-that-the-Resubmitted-Tabelecleucel-Tab-cel-Biologics-License-Application-Has-Been-Accepted-by-the-U.S.-Food-and-Drug-Administration Prescription Drug User Fee Act (PDUFA) Target Action Date of March 31, 2027

$ATRA Atara Biotherapeutics' Partner Pierre Fabre Pharmaceuticals Receives FDA Acceptance To Refile Biologics License Application For Tabelecleucel To Treat Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

$ATRA — Atara just moved an important regulatory piece forward with the BLA resubmission for tabelecleucel. This is an off-the-shelf T-cell immunotherapy being developed for EBV-positive post-transplant lymphoproliferative disease. With the application back in the FDA’s hands, regulatory progress becomes the main event here.

$ATRA Atara Biotherapeutics Reports that the Tabelecleucel Biologics License Application Has Been Resubmitted to the U.S. Food and Drug Administration https://www.businesswire.com/news/home/20260930946884/en/Atara-Biotherapeutics-Reports-that-the-Tabelecleucel-Biologics-License-Application-Has-Been-Resubmitted-to-the-U.S.-Food-and-Drug-Administration • Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $31 million milestone payment upon FDA approval of the tabelecleucel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales.

$ATRA Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration

$ATRA "The BLA was resubmitted in 2025 after reaching alignment with the FDA on the acceptability of the resubmission criteria and fulfillment of the conditions as identified in the first Complete Response Letter in January 2025. As previously disclosed, in the First CRL, the FDA identified a single deficiency regarding Good Manufacturing Practice (GMP) compliance and did not raise any concerns with respect to the safety, efficacy, or trial design. In the current CRL, the FDA confirmed that the GMP compliance issues had been satisfactorily resolved, and no safety issues were raised. However, in a complete reversal of position by the FDA, the CRL claims that the single-arm ALLELE trial, which the FDA previously confirmed as adequate to support the BLA filing, is no longer considered to be adequate to provide evidence of effectiveness for accelerated approval."

$ATRA Atara Biotherapeutics Reports that the Tabelecleucel Biologics License Application Has Been Resubmitted to the U.S. Food and Drug Administration