Senti Biosciences announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead candidate, SENTI‑202, a logic‑gated off‑the‑shelf CAR‑NK cell therapy for relapsed or refractory acute myeloid leukemia (AML). The designation, awarded on December 9 2025, signals that the FDA views the early clinical data as demonstrating a substantial improvement over existing treatments for a serious, life‑threatening disease and allows the company to engage in accelerated development and review pathways, including rolling and priority review.
The clinical data presented at the American Society of Hematology meeting on December 8 2025 showed that 4 of 7 evaluable patients achieved composite complete remission and measurable residual disease negativity. In the broader Phase 1 cohort of 18 evaluable patients, the overall response rate was 50 % and 42 % of patients reached complete remission or CR with partial hematologic recovery (CRh). All complete remissions were measurable residual disease negative, and the median duration of remission was 7.6 months. The data underscore the platform’s ability to selectively target leukemic blasts while sparing healthy hematopoietic stem cells, a safety advantage that differentiates SENTI‑202 from other cell therapies.
CEO Timothy Lu said the RMAT designation validates the unmet need for better treatments in relapsed/refractory AML and highlights the promise of SENTI‑202 to transform the therapeutic landscape. Chief Medical Officer Kanya Rajangam added that the gene‑circuit technology enables the therapy to kill cancer cells aggressively while protecting normal cells, reinforcing the company’s competitive edge in the emerging off‑the‑shelf CAR‑NK market.
Senti’s financial position remains a concern. The company reported a Q3 2025 net loss of $18.1 million and held $12.2 million in cash as of September 30 2025, raising substantial doubt about its going‑concern status. The regulatory milestone and positive clinical data provide a critical boost to the company’s development pipeline, but the limited cash runway underscores the need for additional funding to advance SENTI‑202 into pivotal studies.
The market reacted positively to the announcement, with investors viewing the RMAT designation and encouraging Phase 1 results as a significant step toward accelerated approval and a stronger competitive position in the AML treatment space.
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