ATRA News & Events

Atara Biotherapeutics announced that its partner Pierre Fabre Pharmaceuticals 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, providing additional context and clarification that the ALLELE study was adequate, well-controlled, and sufficient to support the tabelecleucel biologics license application. In addition, the briefing book includes summaries of updated, longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission. "With our partners at Pierre Fabre Pharmaceuticals, we are eager to engage in a constructive discussion with the FDA to reach a path forward for tabelecleucel," said Cokey Nguyen, president and CEO of Atara. "The PTLD community, including physicians and patient advocacy groups have emphasized the urgent need for tabelecleucel and its ability to address a dire unmet medical need in this ultra-rare disease."

Atara Biotherapeutics announced that the company entered into an amendment to the purchase and sale agreement dated as of December 20, 2022 with a fund managed by HealthCare Royalty. Under the terms of the amendment, HCRx agreed to amend the due date of the one-time of $9M cash payment associated with the achievement of a certain milestone within the amended and restated commercialization agreement dated October 31, 2023, with Pierre Fabre Medicament, as amended, from June 30 to January 1, 2028. In connection with the amendment, the company issued a warrant to purchase up to 400,000 shares of the company's common stock. The exercise price of the warrant is equal to $0.0001 per share, subject to adjustment as provided therein, and the warrants will be exercisable immediately and have no expiration date. The exercise of the warrant is subject to a beneficial ownership limit as set forth in the warrant.

Atara Biotherapeutics announced that the FDA has issued a complete response letter, or CRL, for the Ebvallo biologics license application as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease, who have received at least one prior therapy including an anti-CD20 containing regimen. The CRL indicates that the FDA is unable to approve the Ebvallo BLA in its present form. The BLA was resubmitted in 2025 after reaching alignment with the FDA on the acceptability of the resubmission criteria and fulfilment of the conditions as identified in the first complete response letter dated January 15. In the First CRL, the FDA identified a single deficiency regarding good manufacturing practice compliance and did not raise any concerns with respect to the safety, efficacy or trial design. In the current CRL, received after market close on January 9, the FDA confirmed that the GMP compliance issues had been satisfactorily resolved, and importantly, 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 was previously confirmed by the FDA as adequate to support the BLA filing, is no longer considered to be adequate to provide evidence of effectiveness for accelerated approval. Furthermore, the FDA stated that the trial's interpretability is confounded due to trial study design, conduct, and analysis. The FDA's new position is contrary to the FDA's prior guidance to Atara, the FDA's alignment with Atara on the clinical trial data set, and the acceptance of the trial design as a single arm study as relevant for this patient population at BLA submission. This prior alignment had been reached by Atara and the FDA through multiple, documented meetings held over the past five plus years. In November 2025, Atara transferred the BLA to Pierre Fabre Pharmaceuticals, the U.S. pharmaceutical subsidiary of Pierre Fabre Laboratories. As a first step towards resolution, PFP intends to request a Type A meeting and expects it to be granted within 45 days. PFP and Atara plan to urgently interact with the FDA to find a path forward for the timely accelerated approval of Ebvallo without which patients with EBV+ PTLD have extremely limited treatment options and a life expectancy often measured in weeks to months.