Alto Neuroscience Surges on FDA Fast Track for Schizophrenia Drug
Regulators expedite review for ALTO-101, targeting a key aspect of schizophrenia with no currently approved treatments.
Shares of Alto Neuroscience (ANRO) jumped 12% in pre-market trading after the U.S. Food and Drug Administration granted Fast Track designation for its novel treatment targeting cognitive impairment associated with schizophrenia (CIAS). The designation highlights the urgent need for new therapies in a field with significant unmet medical needs and signals a potentially shorter path to regulatory approval.
The drug, ALTO-101, is being developed to address the debilitating cognitive deficits—such as impaired memory, attention, and executive function—that are a core feature of schizophrenia. This aspect of the illness severely impacts patients' ability to function independently, yet there are currently . The Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.
ALTO-101, a novel small molecule PDE4 inhibitor, works by increasing levels of a key neurotransmitter signaling molecule, which is believed to improve cognitive function. The company reported that Phase 1 testing in healthy volunteers demonstrated promising pro-cognitive effects. The allows for more frequent meetings with the agency and makes the drug potentially eligible for Accelerated Approval and Priority Review.
In a , Alto's founder and CEO, Amit Etkin, M.D., Ph.D., said the designation "underscores the critical need for new, effective treatments for patients suffering from cognitive impairment associated with schizophrenia." He added that the company is committed to advancing the program for patients who currently have no approved therapeutic options.
With the regulatory path now clarified, investor focus will shift to the drug's clinical progress. to evaluate ALTO-101 in patients with CIAS, the results of which will be a key catalyst for the company's future.