Cantor outlines how to navigate the emerging Bitcoin treasury sector
THOUSAND OAKS, Calif. - Atara Biotherapeutics, Inc. (Nasdaq:ATRA) announced Thursday that the U.S. Food and Drug Administration has accepted its Biologics License Application for tabelecleucel (tab-cel) with priority review status. The news has contributed to the company’s strong market performance, with InvestingPro data showing a 26% gain in the past week and nearly 50% surge over six months.
The application seeks approval for tab-cel as a monotherapy for adult and pediatric patients two years and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. The FDA has set a Prescription Drug User Fee Act target action date of January 10, 2026.
If approved, tab-cel would become the first therapy authorized in the U.S. specifically for EBV+ PTLD. Currently, no FDA-approved treatments exist for this condition.
"The acceptance of the tab-cel resubmission moves us one step closer towards making this first-of-its-kind treatment available to patients in the U.S.," said Cokey Nguyen, President and Chief Executive Officer of Atara, according to the company’s press release.
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target EBV-infected cells. The application is supported by data from over 430 patients, including the pivotal ALLELE study that demonstrated a 48.8% objective response rate and a favorable safety profile.
The therapy has previously received Breakthrough Therapy Designation from the FDA for treating rituximab-refractory EBV-associated lymphoproliferative disease, as well as orphan drug designation for EBV-positive post-transplant lymphoproliferative disorders.
Atara is working with Pierre Fabre Pharmaceuticals to prepare for a potential U.S. launch pending regulatory approval. With a market capitalization of $86 million and significant revenue growth, investors seeking deeper insights into Atara’s financial health and growth prospects can access additional analysis and 12 more exclusive ProTips through InvestingPro.
In other recent news, Atara Biotherapeutics has made significant strides with its lead candidate, tabelecleucel (tab-cel). The U.S. Food and Drug Administration (FDA) has accepted Atara’s Biologics License Application (BLA) for tab-cel, targeting Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in both adult and pediatric patients. This acceptance follows Atara’s resubmission of the BLA, which addressed prior manufacturing facility observations noted by the FDA. Approval of this application would make tab-cel the first FDA-approved therapy for this specific condition. Additionally, Atara has announced a stock and warrant offering, pricing 834,237 shares of common stock and pre-funded warrants for 1,587,108 shares, aiming to raise $16 million in gross proceeds. The funds are intended to support the ongoing development of tab-cel and general corporate purposes. If the FDA approves tab-cel, Atara will also receive a $40 million milestone payment from its partner, Pierre Fabre Laboratories. These developments mark important progress for Atara as it seeks to advance its therapeutic offerings.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.