Alto Neuroscience Soars 56% on FDA Fast Track for Schizophrenia Drug
The designation for ALTO-101 targets cognitive impairment, a debilitating condition with no currently approved treatments, signaling a major regulatory milestone.
Shares of Alto Neuroscience (NYSE: ANRO) skyrocketed more than 56% after the company announced it had received a significant regulatory boost from the U.S. Food and Drug Administration. The FDA granted Fast Track designation to ALTO-101, the company's investigational treatment for cognitive impairment associated with schizophrenia (CIAS).
The designation, announced on October 5th, underscores the critical unmet medical need for patients with CIAS, a core symptom of schizophrenia that severely impacts daily functioning and for which there are no currently approved therapies. The Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions, potentially leading to earlier patient access. This news marks a pivotal moment for the company and its lead drug candidate, as confirmed in the .
ALTO-101 is a novel phosphodiesterase-4 (PDE4) inhibitor that works to improve cognitive function, a crucial area for patients. The FDA's decision was supported by promising Phase 1 study data in healthy volunteers which demonstrated pro-cognitive effects. These results showed clinically relevant improvements in both brain-based electroencephalogram (EEG) measures and cognitive performance, .
In a statement, Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience, hailed the decision. 'The receipt of Fast Track designation from the FDA is a significant milestone for the ALTO-101 program and validates the potential of our novel, targeted approach,' he said. 'It underscores the profound need for effective treatments for patients impacted by the cognitive impairment associated with schizophrenia.'
With the Fast Track status, Alto Neuroscience may benefit from more frequent meetings with the FDA and could be eligible for Accelerated Approval and Priority Review if relevant criteria are met. The company is currently enrolling patients in a Phase 2 proof-of-concept study of ALTO-101. Investors reacted with strong enthusiasm to the news, seeing the designation as a key de-risking event that for a potentially first-in-class treatment.