Senti Biosciences Soars 7.91% on FDA Orphan Drug Designation

On June 18, 2025, Senti Biosciences saw a significant rise of 7.91% in pre-market trading, reflecting a surge in investor confidence and market optimism.

Senti Biosciences has recently received FDA Orphan Drug Designation for SENTI-202, a first-in-class off-the-shelf Logic Gated CAR NK cell therapy targeting acute myeloid leukemia (AML). This designation provides several benefits, including tax credits, FDA fee exemptions, and potential seven-year market exclusivity upon approval. The therapy is designed to selectively target CD33 and/or FLT3-expressing hematologic malignancies while protecting healthy bone marrow cells, addressing a critical challenge in AML treatment: tumor heterogeneity and off-target toxicity.

The FDA's Orphan Drug Designation for SENTI-202 represents a significant regulatory milestone for Senti Biosciences' gene circuit platform technology. This designation offers tangible benefits including tax credits, clinical trial fee exemptions, and potential 7-year market exclusivity upon approval – advantages that reduce development costs and strengthen commercial prospects. The designation validates Senti's platform approach while addressing a genuine unmet need – AML affects 20,800 newly diagnosed patients annually with poor outcomes (60% relapse or death within 12 months, median survival of just 5.3 months for relapsed/refractory patients).