Atara Biotherapeutics Q2: Tab-cel PDUFA target date set for Jan 10, 2026.

• Atara Biotherapeutics reports Q2 financial results • Tab-cel PDUFA target action date set for Jan 10, 2026 • Operational activities transferred to Pierre Fabre Laboratories • Strategic options evaluation resumed • BLA approval could unlock $40mln milestone payment • Cash runway extended materially

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, has announced its second-quarter 2025 financial results and operational updates. The company reported a net income of $2.4 million, or $0.20 basic earnings per share and $0.19 diluted earnings per share for the quarter ended June 30, 2025. Total revenues were $17.6 million for the second quarter 2025, compared to $28.6 million for the same period in 2024, primarily due to the accelerated recognition of deferred revenue following the transition of manufacturing responsibilities to Pierre Fabre Laboratories [1].

The U.S. Food and Drug Administration (FDA) has accepted the filing of Atara’s Biologics License Application (BLA) for tabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD). The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. This approval, if granted, would unlock a $40 million milestone payment and double-digit tiered royalties as a percentage of net sales and milestones related to commercial sales of EBVALLO [2].

Atara has also completed transferring substantially all operational activities and associated costs related to tab-cel to Pierre Fabre Laboratories. This move is expected to drive a significant reduction in operating expenses for the company. The company anticipates that its cash, cash equivalents, and short-term investments as of June 30, 2025, combined with the proceeds of the milestone payment upon tab-cel BLA approval, will provide substantial cash runway and flexibility for executing strategic priorities [2].

The company has resumed its evaluation of strategic options following the resubmission of the tab-cel BLA. These options may include acquisitions, mergers, reverse mergers, licensing, sales of assets, or other strategic transactions. Atara has not yet determined whether it will pursue any strategic alternatives or if they will be consummated [2].

Atara Biotherapeutics is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions. The company's advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target Epstein-Barr virus (EBV), the root cause of certain diseases. Atara is headquartered in Southern California [2].

References:

[1] https://www.bakersfield.com/ap/news/atara-biotherapeutics-announces-second-quarter-financial-results-and-operational-progress/article_fb97e0de-1a6b-56fd-9178-1747f1ebd500.html

[2] https://www.marketscreener.com/news/atara-biotherapeutics-announces-second-quarter-financial-results-and-operational-progress-ce7c5ed3d980f720