Alto Neuroscience Inc (NYSE:ANRO) stock surged 32.3% Friday after the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug candidate ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS).
The FDA’s Fast Track designation is designed to expedite the development and review of drugs that address serious conditions with unmet medical needs. For Alto, this could mean more frequent meetings with the FDA, as well as potential eligibility for accelerated approval and priority review.
ALTO-101 is a novel small molecule phosphodiesterase-4 (PDE4) inhibitor designed to enhance cognitive function by increasing cyclic adenosine monophosphate (cAMP) levels in the brain. The company highlighted that there are currently no approved treatments for CIAS, which affects millions of patients with schizophrenia and significantly impacts their daily functioning and quality of life.
"Receiving Fast Track designation from the FDA underscores the critical need for new, effective treatments for patients suffering from cognitive impairment associated with schizophrenia," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience.
The company reported that Phase 1 data for ALTO-101 demonstrated "significant and clinically relevant effects" on both electroencephalogram (EEG) measures and cognitive performance in healthy subjects, which Alto believes validates the drug’s mechanism of action.
The clinical-stage biopharmaceutical company focuses on developing precision medicines for neuropsychiatric disorders and aims to address the cognitive deficits in schizophrenia, which include impaired attention, memory, and executive functio
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