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 follows an earlier Orphan Drug Designation granted in June 2025 and is intended to fast‑track the therapy’s development, review, and potential approval.
The RMAT status gives Senti priority interactions with the FDA, the possibility of priority review, and a more streamlined regulatory pathway. By meeting the RMAT criteria, SENTI‑202 is positioned to receive accelerated guidance and potentially reach patients sooner than a standard development program would allow.
Clinical data presented at the American Society of Hematology (ASH) meeting in December 2025 showed that 20 patients treated at the recommended phase‑2 dose achieved a 50 % overall response rate and a 42 % complete remission (CR) or CR with partial hematologic recovery (CRh) rate. All complete remissions were measurable‑by‑rim‑negative, with a median duration of 7.6 months and the longest remission lasting over 11 months. No dose‑limiting toxicities or serious adverse events related to the therapy were reported, underscoring its safety profile.
CEO Timothy Lu said, “The RMAT designation is a significant milestone that validates the clinical promise of SENTI‑202 and accelerates our path to patients. The data from the ASH presentation demonstrate robust efficacy and a favorable safety profile, reinforcing our strategy to bring this next‑generation cell therapy to market.”
The designation is expected to strengthen Senti’s oncology pipeline, enhance investor confidence, and position the company to address a critical unmet need in AML. By expediting regulatory review, the company can potentially bring a novel, off‑the‑shelf therapy to patients faster, thereby improving its competitive standing and long‑term growth prospects.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.