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Marinus Pharmaceuticals, Inc. (MRNS) is a clinical-stage biopharmaceutical company committed to improving the lives of patients suffering from epilepsy and neuropsychiatric disorders. The company is at the forefront of developing and commercializing ganaxolone, a novel therapeutic aimed at addressing a range of conditions including epileptic seizures in both adults and children, as well as postpartum depression in women.
One of the significant milestones for Marinus came on June 29, 2017, when the U.S. Food and Drug Administration (FDA) granted orphan drug designation to ganaxolone for the treatment of CDKL5 disorder. This severe and rare genetic disorder affects children from an early age, leading to difficult-to-control seizures and neuro-developmental impairments. Orphan drug designation is a status granted by the FDA's Office of Orphan Products Development to novel drugs that treat rare diseases or conditions impacting fewer than 200,000 patients in the U.S. This designation not only underscores the urgent need for treatment options for CDKL5 disorder but also provides Marinus with various development incentives including tax credits and market exclusivity.
Marinus Pharmaceuticals manages its operations in a single segment focused on the identification and development of neuropsychiatric therapeutics. Beyond CDKL5 disorder, the company is advancing ganaxolone for multiple epilepsy and neuropsychiatric indications. These include adjunctive therapy for drug-resistant focal onset seizures, status epilepticus, Fragile X Syndrome, and PCDH19-related epilepsy.
With an unwavering focus on patient well-being, Marinus is poised to deliver groundbreaking solutions that address some of the most challenging neurological and psychiatric conditions. The company continues to make strides in clinical research and aims to bring much-needed therapies to market, demonstrating its commitment to transforming patient care.
FAQ
What is the current stock price of Marinus Pharmaceuticals (MRNS)?
The current stock price of Marinus Pharmaceuticals (MRNS) is $0.5466 as of February 4, 2025.
What is the market cap of Marinus Pharmaceuticals (MRNS)?
The market cap of Marinus Pharmaceuticals (MRNS) is approximately 30.1M.
What is Marinus Pharmaceuticals, Inc.?
Marinus Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapeutics for epilepsy and neuropsychiatric disorders.
What is ganaxolone?
Ganaxolone is an innovative therapeutic being developed by Marinus Pharmaceuticals to treat conditions such as epileptic seizures, postpartum depression, and other neuropsychiatric disorders.
What is CDKL5 disorder?
CDKL5 disorder is a severe, rare genetic condition affecting children, causing difficult-to-control seizures and neuro-developmental impairments.
What does orphan drug designation mean?
Orphan drug designation is granted by the FDA to novel drugs that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S., providing development incentives like tax credits and market exclusivity.
Which other conditions is ganaxolone being developed for?
Ganaxolone is also being developed for drug-resistant focal onset seizures, status epilepticus, Fragile X Syndrome, and PCDH19-related epilepsy.
When did Marinus receive orphan drug designation for ganaxolone?
Marinus received orphan drug designation for ganaxolone on June 29, 2017.
What incentives does orphan drug designation provide?
Orphan drug designation provides various development incentives including tax credits, market exclusivity, and assistance with clinical trial design.
What is the primary area of focus for Marinus Pharmaceuticals?
Marinus Pharmaceuticals primarily focuses on the development and commercialization of neuropsychiatric therapeutics.
Why is ganaxolone significant?
Ganaxolone is significant because it aims to address unmet clinical needs in conditions like epilepsy and postpartum depression, offering new hope for patients.
How does Marinus Pharmaceuticals impact patient care?
Marinus Pharmaceuticals impacts patient care by bringing innovative therapies to market, particularly for challenging neurological and psychiatric conditions.