Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update

Excerpt from the Press Release:

RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures associated with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy. An NDA filing notification letter from the FDA is expected before the end of Q3 2021. If the NDA is accepted for filing by the FDA, this will enable the company to draw $30 million of additional cash under its credit financing agreement with Oaktree Capital Management, L.P., on or before December 31, 2021, subject to the satisfaction of certain customary conditions described in the credit agreement.

“We have been diligently focused on advancing ganaxolone’s clinical development for patients suffering from CDD, a devastating disease with high unmet medical need, and are pleased to have reached this important milestone,” said Joseph Hulihan, M.D., Chief Medical Officer of Marinus. “We look forward to working with the FDA in their review process and remain focused on preparing for the anticipated U.S. launch. With our European commercial partner in place, we are equally committed to advancing ganaxolone for CDD patients in markets outside the U.S. and plan to submit a marketing authorization application to the European Medicines Agency later this year.”

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