Atara receives action date for tabcel
Thousand Oaks-based Atara Biotherapeutics announced that its partner, Pierre Fabre Pharmaceuticals, received acceptance by the U.S. Food and Drug Administration of the Biologics License Application for tabelecleucel, Atara’s lead product, on Oct. 14.
With the notice, the FDA also set a target action date for the drug on March 31.
Tabelecleucel, sold under the brand name Ebvallo, is a medication used for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease. It was granted marketing authorization in December 2022 by the European Commission, as well as marketing authorization in the United Kingdom in May 2023 and in Switzerland in May 2024.
If approved, Atara would be eligible to receive a $31 million milestone payment under its commercialization agreement with Pierre Fabre Laboratories. Atara would also be eligible to receive significant double-digit tiered royalties on net sales and additional commercial sales milestones.
In its latest earnings, Atara announced cash, cash equivalents and short-term investments as of June 30 totaled $9.9 million. That is enough to fund the company through mid-2027. The company only generated $600,000 in revenue in its second-quarter earnings announcement.
“The acceptance of the tabelecleucel resubmission brings us one step closer to making this first-of-its-kind treatment available to patients in the U.S.,” said Cokey Nguyen, president and CEO of Atara. “We appreciate the Agency’s guidance and look forward to a collaborative review process. We will continue supporting PFP as it prepares for a potential U.S. launch.”
