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MOUNTAIN VIEW, Calif. - Alto Neuroscience, Inc. (NYSE:ANRO), a clinical-stage biopharmaceutical company with a market capitalization of $119 million, announced Friday that the U.S. Food and Drug Administration has granted Fast Track designation to its investigational drug ALTO-101 for treating cognitive impairment associated with schizophrenia (CIAS). According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, though it is currently not profitable.
The designation is designed to expedite the development and review of drugs intended to address serious conditions with unmet medical needs. Companies with Fast Track designation may receive more frequent FDA meetings and potential eligibility for accelerated approval.
ALTO-101 is a phosphodiesterase-4 (PDE4) inhibitor that works by increasing cyclic adenosine monophosphate (cAMP) levels in the brain, which is believed to enhance neural circuits and improve cognitive function.
Cognitive impairment, which affects memory, attention, and executive function, is a core feature of schizophrenia that significantly impacts patients’ ability to work, maintain relationships, and live independently. Currently, no FDA-approved treatments exist for CIAS.
With analysts setting price targets ranging from $4 to $15 per share and maintaining a strong buy consensus, market expectations appear optimistic about the company’s potential. "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, founder and chief executive officer of Alto Neuroscience, in a press release statement.
The company reports that ALTO-101 has demonstrated pro-cognitive effects in healthy volunteers during Phase 1 testing, showing significant effects on both EEG measures and cognitive performance. Enrollment is ongoing in a Phase 2 proof-of-concept study evaluating the drug in patients with CIAS.
Alto Neuroscience is developing treatments for neuropsychiatric disorders using its Precision Psychiatry Platform, which analyzes brain biomarkers through EEG activity, neurocognitive assessments, and other data to identify patients more likely to respond to specific treatments. The company’s stock has shown strong momentum, gaining over 11% in the past week and 138% over the last six months. Get more detailed insights and discover 8 additional key metrics with InvestingPro.
In other recent news, Alto Neuroscience has announced several significant developments. The company reported that H.C. Wainwright reiterated its Buy rating for Alto Neuroscience, maintaining a price target of $10.00. This decision follows a meeting with the company’s management, where Alto’s precision psychiatry approach was highlighted. Additionally, Alto Neuroscience appointed Raymond Sanchez, M.D., to its Board of Directors, effective August 2025. Dr. Sanchez brings experience from his role as Senior Advisor at Bain Capital Life Sciences and his previous position as Chief Medical Officer at Cerevel Therapeutics Holdings. The company also repriced certain employee and consultant stock options to $2.35 per share, affecting options under its 2019 and 2024 Equity Incentive Plans. This repricing impacts 4,225,763 shares but excludes options held by non-employee directors. These recent developments are part of Alto Neuroscience’s ongoing efforts to enhance its strategic and operational framework.
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