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Senti Bio Granted U.S. FDA Orphan Drug Designation for Use of First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, SENTI-202 to Treat Acute Myeloid Leukemia

1. Senti Bio's SENTI-202 progresses in Phase 1 trial for AML treatment. 2. FDA grants Orphan Drug Designation, enhancing SNTI's market potential.

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Why Bullish?

The FDA's Orphan Drug Designation boosts investor confidence. Similar designations have led to stock surges in biotech companies.

How important is it?

The article's focus on clinical progress and regulatory approval indicates significant potential for SNTI's valuation increase.

Why Long Term?

The long-term prospects depend on trial results and market adoption, reminiscent of other FDA-designated therapies that doubled market capitalizations over time.

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Ongoing progress in Phase 1 clinical trial of SENTI-202 for the treatment of Acute Myeloid Leukemia (AML) 20,800 newly diagnosed AML patients in the U.S. every year 1 with 60% of patients experiencing relapse or death within 12 months 2 Management releases Virtual Investor “What This Means” segment; Access here SOUTH SAN FRANCISCO, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including AML.

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