Marinus: FDA Accepts Application for Ganaxolone in CDKL5 Deficiency Disorder

By Michael Dabaie

Marinus Pharmaceuticals Inc. said the U.S. Food and Drug Administration accepted for filing its new drug application for ganaxolone in the treatment of seizures associated with CDKL5 deficiency disorder, a rare, genetic epilepsy.

The FDA granted the application priority review designation and assigned a prescription drug user fee act action date of March 20, 2022.

In its acceptance letter, the FDA indicated it isn't currently planning to hold an advisory committee meeting to discuss the application.

The acceptance of the NDA for filing enables the company to draw $30 million of additional cash under its May 11, 2021, credit financing agreement with Oaktree Capital Management L.P.

If the NDA is approved by Dec. 31, 2022, the company can draw an additional $30 million under the agreement.

The FDA gives priority review designation to an investigational medicine that would be a significant improvement in the safety or effectiveness of the treatment of a serious condition. The designation accelerates the timing of the FDA review of the application compared to a standard review.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

September 20, 2021 08:01 ET (12:01 GMT)

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