Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 to Treat Cognitive Impairment in Schizophrenia
Reuters
Oct 03, 2025
Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 to Treat Cognitive Impairment in Schizophrenia
Alto Neuroscience Inc. (NYSE: ANRO), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug ALTO-101 for the treatment of cognitive impairment associated with schizophrenia $(CIAS)$. This regulatory milestone highlights the urgent need for new therapies targeting CIAS, a condition that significantly affects daily functioning in patients with schizophrenia and currently has no approved treatments. ALTO-101, a novel small molecule PDE4 inhibitor, has shown promising results in Phase 1 trials by improving cognitive performance and related brain activity measures. The Fast Track designation will facilitate closer collaboration with the FDA and may expedite the drug's development and review process. This designation was granted solely to Alto Neuroscience Inc.
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