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MOUNTAIN VIEW, Calif. - Alto Neuroscience, Inc. (NYSE: ANRO), a clinical-stage biopharmaceutical company currently valued at $74 million, has announced at the American Society of Clinical Psychopharmacology Annual Meeting that its drug ALTO-300 showed a favorable tolerability profile in recent trials for major depressive disorder (MDD). According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 22.5, though it faces significant cash burn challenges typical of early-stage biotech firms. The presentation, which took place between May 27-30, 2025, highlighted the ongoing Phase 2b trial and completed Phase 2a trial results of the 25mg dose of ALTO-300.
ALTO-300, also known as agomelatine, is being developed as an adjunctive treatment in the United States for patients with MDD, identified by an EEG biomarker. Agomelatine, already approved in Europe and Australia at both 25mg and 50mg doses, has not received approval in the U.S. The 50mg dose has been associated with reversible liver enzyme elevations, but the 25mg dose has demonstrated similar antidepressant activity without significant liver function test (LFT) elevations.
Amit Etkin, M.D., Ph.D., CEO of Alto Neuroscience, stated that the 25mg dose of ALTO-300 balances antidepressant efficacy with safety, avoiding the LFT elevation rates associated with the higher dose. The Phase 2a trial involving 239 patients reported no significant LFT elevations, and no patients in the ongoing Phase 2b trial have been stopped due to liver enzyme elevation. While the clinical results appear promising, InvestingPro analysis shows the company’s stock has declined by 78% over the past year, with shares currently trading at $2.72, significantly below their 52-week high of $17.55.
The company’s research has also linked ALTO-300 to an EEG biomarker, suggesting a mechanistic connection between the drug and the biomarker used for patient selection. According to the data, the biomarker signal likely reflects increased neural noise due to elevated 5-HT2C tone and reduced dopaminergic activity, which is the opposite effect of ALTO-300.
The most common adverse event observed in the Phase 2a trial was a headache. The Phase 2b trial includes a stopping rule for elevated liver enzymes, but no such events have warranted cessation thus far.
Alto Neuroscience focuses on developing precision medicines for neuropsychiatric disorders, with a pipeline that includes drug candidates for bipolar depression, schizophrenia, and other mental health conditions. The company’s Precision Psychiatry Platform™ measures brain biomarkers to identify patients likely to respond to its product candidates. Financial data from InvestingPro reveals the company holds more cash than debt on its balance sheet, with a debt-to-equity ratio of 0.19, providing some financial flexibility for its development programs. Subscribers to InvestingPro can access 5 additional key insights about Alto Neuroscience’s financial health and market position.
This announcement is based on a press release statement and contains forward-looking statements regarding the potential benefits and effectiveness of Alto Neuroscience’s product candidates and clinical trials. However, actual results may differ due to various factors.
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