FDA Turns Away Minerva's Roluperidone Schizophrenia Drug

Dow Jones02-27

By Colin Kellaher

Minerva Neurosciences on Tuesday said the U.S. Food and Drug Administration has rejected the company's application seeking approval of lead drug candidate roluperidone for the treatment of negative symptoms in patients with schizophrenia.

The Burlington, Mass., clinical-stage biopharmaceutical company said the FDA issued a so-called complete response letter, indicating the agency won't approve the application in its current form, and called for at least one more study.

Minerva said the FDA found that although one study showed statistical significance on the primary efficacy endpoint, it isn't sufficient on its own to establish substantial evidence of effectiveness.

The company said the FDA also found that the application lacks data on concomitant antipsychotic administration and data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.

Minerva said it plans to request a meeting with the FDA to discuss the issues the agency raised and attempt to address its feedback.

Trading in shares of Minerva, which closed Monday at $6.80, was halted premarket on Tuesday.

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

(END) Dow Jones Newswires

February 27, 2024 08:17 ET (13:17 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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