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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.
Marinus Pharmaceuticals, Inc. (MRNS) plans to release its financial results for the first quarter ended March 31, 2023, on May 11, 2023. A conference call will follow at 8:30 a.m. Eastern Time on the same day. Investors can access the call via the company's website. Marinus focuses on developing innovative therapeutics for seizure disorders, with its commercial product, ZTALMY® (ganaxolone), approved by the U.S. FDA for treating seizures associated with CDKL5 deficiency disorder in patients aged two and older. The company is also studying ganaxolone in other rare seizure disorders, including its use in Phase 3 trials for tuberous sclerosis complex and refractory status epilepticus. The drug acts as a GABAA receptor modulator, aiming to enhance treatment for both adult and pediatric patients.
Marinus Pharmaceuticals (NASDAQ: MRNS) has appointed Marvin H. Johnson, Jr. to its Board of Directors, bringing over 34 years of experience from Merck & Co. Johnson's expertise in launching products, especially in neurology, is expected to enhance the commercial success of Marinus' approved product, ZTALMY® (ganaxolone). His role will focus on the upcoming launch for refractory status epilepticus indications. Johnson previously held senior roles overseeing multi-billion dollar sales and marketing organizations at Merck, which underscores his capability to drive growth at Marinus. The company remains committed to developing innovative therapeutics for seizure disorders while navigating the complexities of clinical and commercial operations.
Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) has announced the grant of inducement awards in the form of stock options to five new employees. A total of 93,825 non-qualified stock options will be granted at an exercise price of
Marinus Pharmaceuticals has received orphan drug designation from the FDA for ganaxolone, aimed at treating Lennox-Gastaut syndrome (LGS). This marks the seventh such designation for the drug, underscoring its potential to serve rare epilepsy cases. Marinus plans to start a multiple ascending dose study for a new ganaxolone formulation in Q2 2023 and aims to finalize its clinical program design for LGS by the end of the year. The orphan drug status provides benefits such as market exclusivity upon approval, FDA fee exemptions, and tax credits for clinical trials, emphasizing the company's commitment to addressing unmet needs in the seizure disorder market.
Marinus Pharmaceuticals reported net product revenue of $2.3 million for Q4 2022 and $2.9 million for the full year. The company projects 2023 ZTalmy net revenues between $15 million and $17 million. Phase 3 trials for refractive status epilepticus and tuberous sclerosis complex are ongoing, with topline data expected in 2H 2023 and Q1 2024. Cash and equivalents stood at $240.6 million as of Dec 31, 2022, and the company aims to maintain a minimum cash balance of $15 million into the second half of 2024. However, Marinus faced a net loss of $34.3 million in Q4 2022, despite successful operational advancements.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) has granted inducement awards to a new employee, consisting of non-qualified stock options for 13,800 shares at an exercise price of
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