By Colin Kellaher


Minerva Neurosciences shares lost more than half of their value in early trading Tuesday after the U.S. Food and Drug Administration once again turned away the company's application seeking approval of its lead drug candidate.

Shares of the Burlington, Mass., clinical-stage biopharmaceutical company were recently changing hands at $2.90, down 57%.

Minerva, which was seeking a green light for roluperidone for the treatment of negative symptoms in patients with schizophrenia, said the FDA raised numerous issues with the application and is requiring the company to submit at least one additional positive, adequate and well-controlled study to support the safety and effectiveness of the drug.

The company said the FDA has issued a complete response letter, indicating the agency won't approve the application in its current form.

Minerva initially filed for FDA approval of roluperidone in 2022, but the FDA in October 2022 issued a so-called "refuse-to-file" letter, which the agency says notifies a company that it won't review a marketing application because of significant deficiencies that can't promptly be resolved, making the application substantially incomplete.

Minerva appealed the decision, and the FDA ultimately filed the application for review in April 2023.

Minerva on Tuesday said it plans to request a meeting with the FDA to discuss the issues raised and to work closely with the agency and provide any additional information as needed.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

02-27-24 1017ET