Atara Biotherapeutics transferred the Biologics License Application for its lead allogeneic T‑cell therapy, tabelecleucel, to Pierre Fabre, giving the French company global rights to develop, manufacture, and commercialize the product in the United States and worldwide.
The transfer follows Atara’s resubmission of the BLA on July 11 2025, which the U.S. Food and Drug Administration accepted with priority review on July 23 2025. The BLA carries a Prescription Drug User Fee Act target action date of January 10 2026, and Pierre Fabre will pursue approval and commercialization under that schedule.
Under the new arrangement, Pierre Fabre assumes responsibility for all clinical development, regulatory submissions, manufacturing, and commercial activities. Atara will continue to monitor the regulatory process and provide technical support as needed, but it will no longer directly control the regulatory pathway.
The decision to transfer the BLA was driven in part by a Complete Response Letter issued by the FDA in January 2025 that highlighted manufacturing facility issues. By shifting manufacturing and regulatory responsibilities to Pierre Fabre, Atara aims to streamline the approval process and conserve capital while focusing on its allogeneic CAR‑T pipeline.
Atara has received approximately $27 million in upfront payments and inventory purchases from Pierre Fabre in December 2023 and is eligible for up to $640 million in milestone payments and royalties, including a $40 million milestone upon FDA approval. The partnership provides Atara with a clear pathway to U.S. approval and a potential revenue stream that supports its financial sustainability.
Financially, Atara reported total revenues of $40.2 million for Q3 2024, up from $2.1 million in Q3 2023, and net cash used in operating activities of $4.0 million in Q3 2024 versus $51.3 million in Q3 2023. The company’s cash position was $42.5 million as of December 31 2024, and the BLA transfer is expected to extend its cash runway into 2027.
The move signals Atara’s shift toward a lean, partnership‑driven model, allowing it to concentrate resources on its core CAR‑T programs while leveraging Pierre Fabre’s manufacturing and commercial capabilities for tabelecleucel.
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