Atara Biotherapeutics Schedules FDA Meeting on Tabelecleucel Application
Atara Biotherapeutics announced a Type A meeting with the FDA to discuss the Complete Response Letter for tabelecleucel's Biologics License Application, held by partner Pierre Fabre Pharmaceuticals.
Atara Biotherapeutics Inc. (NASDAQ:ATRA) announced that a Type A meeting with the U.S. Food and Drug Administration has been scheduled to discuss the Complete Response Letter for tabelecleucel. The meeting will involve Pierre Fabre Pharmaceuticals, Atara's partner, which holds the Biologics License Application for the treatment.
The companies plan to address points raised in the Complete Response Letter and enable a resubmission with additional efficacy data collected since the original application. Pierre Fabre Pharmaceuticals will lead the FDA meeting with support from Atara to collaboratively address the regulatory feedback and enable the BLA resubmission process.
"We are pleased that the FDA has granted a Type A Meeting to our partner, Pierre Fabre, and hope to gain clarity on a path forward for re-submission of the tab-cel BLA," said the president and chief executive officer of Atara.
The company anticipates providing a regulatory update in the second quarter. The stock jumped 24.6% over the past week following the announcement, though shares remain down 48.6% over six months. With a market cap of $44.92 million, Atara trades at $6.23 per share.
Tabelecleucel is an allogeneic Epstein-Barr virus T-cell immunotherapy. Atara develops T-cell immunotherapies for patients with cancer and autoimmune diseases using its allogeneic Epstein-Barr virus T-cell platform. The company is headquartered in Southern California.
The FDA issued a Complete Response Letter rejecting the company's application for tabelecleucel, a treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease. The FDA's decision was based on concerns about the adequacy of the single-arm ALLELE trial, which was previously deemed acceptable but is now considered insufficient due to issues related to its design, conduct, and analysis.
Atara Biotherapeutics has amended its agreement with HealthCare Royalty, extending the deadline for a $9 million milestone payment from June 30, 2026, to January 1, 2028. This payment is linked to Atara's commercialization agreement with Pierre Fabre regarding tabelecleucel.