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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 (Nasdaq: MRNS) has announced a delay in its RAISE Phase 3 trial for IV ganaxolone due to the COVID-19 Omicron variant's impact on hospital resources and clinical supply interruptions. The trial completion is now expected in the second half of 2023. Additionally, the company aims to resolve supply issues and enhance manufacturing processes to achieve a longer product shelf life. The initiation of two related trials has also been pushed back by six months, but interest in the RAISE trial remains robust with 48 sites activated.
Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) announced a scheduled business update and preliminary financial results for Q4 and fiscal year 2021 on March 21, 2022. The conference call will take place at 8:00 a.m. ET, where the company will discuss its innovative therapeutics aimed at treating seizure disorders, including their lead drug, Ganaxolone. Ganaxolone is designed to enhance GABAA receptor activity, offering potential benefits for both adult and pediatric patients.
Marinus Pharmaceuticals (MRNS) announced the grant of inducement awards to six new employees, including non-qualified stock options for 75,938 shares and restricted stock units for 8,600 shares. The stock options have an exercise price of $11.93 per share, equal to the closing price on February 9, 2022. These awards are designed to attract talent as per Nasdaq Listing Rule 5635(c)(4). The stock options will vest 25% after one year, with the remainder vesting in monthly installments over three years. The restricted stock units fully vest after one year.
Marinus Pharmaceuticals (NASDAQ: MRNS) announced positive preliminary results from an in vivo study of its M2 metabolite, showing no genotoxicity. The study assessed bone marrow micronuclei formation and liver comet morphology. Additionally, the company’s marketing authorization application for ganaxolone in CDKL5 deficiency disorder will shift to a standard review timeline, with an extended Day 120 clock stop by three months. The EMA's opinion on the application is anticipated by year-end 2022. The M2 metabolite study's final report is expected by the end of February 2022.
Marinus Pharmaceuticals (MRNS) has announced the grant of inducement awards to five new employees, including non-qualified stock options for 42,810 shares and restricted stock units for 10,800 shares. The stock options have an exercise price of $11.11 per share, aligning with the closing price on January 11, 2022. Vesting for stock options will occur over four years, while restricted stock units will vest fully after one year. These grants comply with Nasdaq Listing Rule 5635(c)(4), intended to incentivize employee recruitment.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced its participation in two key investment conferences. Management will present at the H.C. Wainwright Bioconnect Conference on January 10, at 7:00 a.m. ET, featuring CEO Scott Braunstein and CFO Steven Pfanstiel. The 40th Annual J.P. Morgan Healthcare Conference is scheduled for January 13, at 8:15 a.m. ET, also with Scott Braunstein presenting. Both events will be available via webcast, allowing stakeholders to engage with the company's mission in treating seizure disorders.
Marinus Pharmaceuticals announced the grant of inducement awards to five new employees, which includes non-qualified stock options for 59,750 shares and restricted stock units for 3,400 shares. The stock options have an exercise price of
Marinus Pharmaceuticals (NASDAQ: MRNS) announced new clinical trial data to be presented at the American Epilepsy Society Annual Meeting in Chicago. The data includes findings on ganaxolone's safety and efficacy in treating CDKL5 deficiency disorder and super-refractory status epilepticus. Key results show a 30.1% to 53.8% reduction in seizure frequency among patients over 12 months. The company will hold a virtual investor event on December 6 to discuss these findings.
Marinus Pharmaceuticals (MRNS) announced the acceptance of nine abstracts for presentation at the American Epilepsy Society's Annual Meeting in Chicago from December 3 to 7, 2021. Key highlights include clinical data on ganaxolone in CDKL5 deficiency disorder, which is currently under FDA review, as well as findings for tuberous sclerosis complex and Lennox-Gastaut syndrome. CEO Scott Braunstein emphasized the significance of new safety and efficacy data for ganaxolone. Additionally, a virtual investor event is scheduled to provide updates on their pipeline programs.
Marinus Pharmaceuticals (NASDAQ: MRNS) announced its participation in key investor conferences in November and December. Leadership will present at the Jefferies London Healthcare Conference from November 18-19, featuring CEO Scott Braunstein and CFO Steven Pfanstiel. They will also host a Virtual Investor Event at the American Epilepsy Society's Annual Meeting on December 6. Additionally, one-on-one meetings will occur at the Jefferies Denver Healthcare Summit on December 16. Marinus focuses on innovative treatments for rare seizure disorders, including ongoing Phase 3 trials for ganaxolone.
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