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Alto Neuroscience Receives FDA Fast Track Designation for Drug Candidate ALTO-101 for Cognitive Impairment in Schizophrenia

By Maham Fatima | October 17, 2025, 9:27 AM

Alto Neuroscience Inc. (NYSE:ANRO) is one of the best young stocks with huge upside potential. On October 3, Alto Neuroscience announced that the US FDA granted Fast Track designation to its drug candidate, ALTO-101, for the treatment of cognitive impairment associated with schizophrenia/CIAS.

The designation may make ALTO-101 eligible for more frequent meetings with the FDA, as well as possible accelerated approval and priority review, provided relevant criteria are met. The designation highlights the significant unmet need for new treatments for CIAS, a core, debilitating feature of schizophrenia for which there are currently no approved treatments.

Alto Neuroscience Receives FDA Fast Track Designation for Drug Candidate ALTO-101 for Cognitive Impairment in Schizophrenia

ALTO-101 is a novel small molecule phosphodiesterase-4/PDE4 inhibitor. The mechanism of action is based on PDE4’s role in breaking down cyclic adenosine monophosphate/cAMP, a molecule essential for neuronal signaling and synaptic plasticity. By inhibiting PDE4, ALTO-101 is believed to increase cAMP levels, thereby enhancing neural circuits and potentially improving cognitive function, which includes deficits in attention, memory, and executive function seen in schizophrenia.

Alto Neuroscience Inc. (NYSE:ANRO) is a clinical-stage biopharmaceutical company in the US. The company was incorporated in 2019 and is headquartered in Mountain View, California.

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READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure: None. This article is originally published at Insider Monkey.

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