ATRA News & Events

Atara Biotherapeutics announced that a Type A meeting with the FDA has been scheduled to discuss the complete response letter, or CRL, to the biologics license application for tabelecleucel held by its partner Pierre Fabre Pharmaceuticals. Pierre Fabre Pharmaceuticals, with Atara's support, will meet with the agency to collaboratively address the points from the CRL and enable a resubmission with the additional efficacy data that has been collected since the original BLA submission.

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.