Marinus Pharmaceuticals Inc (NASDAQ: MRNS) shares are trading higher by 25.0% at $10.72 after the company announced the FDA has approved ZTALMY oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder.
Marinus Pharmaceuticals says ZTALMY, the first FDA approved treatment specifically in CDD, is a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor. It is expected to be available through a designated specialty pharmacy in July 2022.
"Today is a historic milestone not only for Marinus but for CDD patients, families and caregivers who have long been navigating the unpredictable, often devastating reality of living with uncontrolled seizures," said Scott Braunstein, M.D., Chief Executive Officer of Marinus.
"The approval of ZTALMY would not have been possible without the patients, caregivers and investigators who participated in the clinical trials to develop this important new therapy. We are grateful and humbled by the opportunity to bring the first and only FDA-approved treatment for seizures associated with CDD to this community," Braunstein stated.
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Marinus Pharmaceuticals is a clinical-stage biopharmaceutical company. The company is focused on developing and commercializing innovative therapeutics to treat epilepsy and neuropsychiatric disorders.
Marinus Pharmaceuticals has a 52-week high of $19.83 and a 52-week low of $7.16.
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