Alto Neuroscience Shares Rise After Getting FDA Fast-Track Designation

By Connor Hart


Shares of Alto Neuroscience jumped after the company said it received a fast-track designation from the Food and Drug Administration for its in-development treatment of cognitive impairment associated with schizophrenia.

The stock climbed 12%, to $4.95, in premarket trading Friday. Through Thursday's close, shares have surged about 88% over the past three months, though they are still down nearly 58% over the past year.

The biopharmaceutical company before the opening bell said there currently aren't any approved treatments for cognitive impairment associated with schizophrenia, a feature of the disease that affects areas such as memory, attention, processing speed and executive functions.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high, unmet medical needs.

"This designation is a significant milestone for the ALTO-101 program and we believe it is a testament to its potential as a novel treatment approach," Chief Executive Amit Etkin said. He added that early data of the treatment demonstrated significant and clinically relevant effects on both electroencephalogram measures and cognitive performance in healthy subjects.

"We are committed to advancing this program expeditiously for the millions of patients who currently have no approved treatment options to address these debilitating cognitive deficits," he said.


Write to Connor Hart at connor.hart@wsj.com


(END) Dow Jones Newswires

October 03, 2025 08:40 ET (12:40 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

The articles, information, and content displayed on this webpage may include materials prepared and provided by third parties. Such third-party content is offered for informational purposes only and is not endorsed, reviewed, or verified by Morningstar.

Morningstar makes no representations or warranties regarding the accuracy, completeness, timeliness, or reliability of any third-party content displayed on this site. The views and opinions expressed in third-party content are those of the respective authors and do not necessarily reflect the views of Morningstar, its affiliates, or employees.

Morningstar is not responsible for any errors, omissions, or delays in this content, nor for any actions taken in reliance thereon. Users are advised to exercise their own judgment and seek independent financial advice before making any decisions based on such content. The third-party providers of this content are not affiliated with Morningstar, and their inclusion on this site does not imply any form of partnership, agency, or endorsement.

Popular

Sponsor Center