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Investing.com -- Alto Neuroscience Inc (NYSE:ANRO) stock surged 81% Monday after the company announced a successful FDA meeting that will accelerate development of its treatment-resistant depression drug ALTO-207.
The clinical-stage biopharmaceutical company also secured $50 million in private placement financing led by Perceptive Advisors, with participation from Commodore Capital, Vestal Point Capital, Vivo Capital, and other biotech investors. The capital will fund ALTO-207’s accelerated development path, with plans to initiate a Phase 2b study by mid-2026 and a Phase 3 trial by early 2027.
"The successful outcome of our recent FDA meeting for ALTO-207 was a critical step forward, and the financing we announced provides us with the resources to expedite its path toward pivotal studies and potential future approval," said Amit Etkin, founder and CEO of Alto Neuroscience .
ALTO-207 is a fixed-dose combination of pramipexole, a dopamine agonist, and ondansetron. The company believes the treatment could serve patients not adequately addressed by current therapies.
Alto also reported positive results from blinded pharmacokinetic analyses across its ongoing Phase 2 studies for ALTO-100 and ALTO-101, with 96% and 100% of samples qualifying as PK positive, respectively. These results suggest strong patient compliance and tolerability.
The company maintains its cash guidance into 2028, which now includes the additional development activities for ALTO-207. Alto expects to report topline data from its ALTO-101 study in cognitive impairment associated with schizophrenia in the first quarter of 2026.
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