Welcome to our dedicated page for Marinus Pharmaceuticals news (Ticker: MRNS), a resource for investors and traders seeking the latest updates and insights on Marinus Pharmaceuticals stock.
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 (MRNS) announces its participation in several investor conferences this September, including the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, H.C. Wainwright 23rd Annual Global Investment Conference on September 13, Baird's 2021 Global Healthcare Conference on September 15, Oppenheimer Fall Healthcare Summit on September 20, and the Cantor Virtual Global Healthcare Conference on September 30. Additionally, Marinus will host a virtual R&D Day on October 5 to discuss pipeline updates.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced topline results from its open-label Phase 2 trial of ganaxolone in 23 patients with seizures associated with tuberous sclerosis complex (TSC). The trial revealed a median 16.6% reduction in seizure frequency over 28 days and demonstrated that 30.4% of participants achieved a 50% or greater reduction in seizures. The results support advancing to a Phase 3 trial and showed positive effects particularly in focal seizures. Ganaxolone received FDA orphan drug designation, enhancing development prospects for rare disorders.
Marinus Pharmaceuticals (MRNS) reported Q2 2021 earnings, noting significant progress in clinical developments. The company submitted a New Drug Application (NDA) for ganaxolone to treat CDKL5 deficiency disorder and expects FDA feedback by Q3 2021. Marinus has partnered with Orion Corporation for European commercialization, generating €25 million upfront. Total cash as of June 30, 2021, was $112.5 million, down from $140 million at year-end 2020. Net losses for Q2 2021 were $23.8 million, with R&D expenses increasing to $18.6 million, reflecting trial activations.
Marinus Pharmaceuticals (Nasdaq: MRNS) has granted non-qualified stock options for a total of 45,625 shares to five new employees as an inducement for their employment. The stock options have an exercise price of $13.27 per share, aligning with the closing stock price on August 5, 2021. Vesting occurs at 25% after one year and the remaining 75% over three years. Marinus focuses on innovative therapies for seizure disorders, including ganaxolone, a GABAA receptor modulator, currently in several clinical trials.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) will release its financial results for Q2 2021 on August 10, 2021, prior to market opening. A conference call will follow at 8:30 a.m. ET to discuss these results and provide a business update. The company is focused on innovative therapeutics for rare seizure disorders, with Ganaxolone, a modulator of GABAA receptors, being a key product. It has completed a Phase 3 trial for CDKL5 deficiency disorder and is currently pursuing trials for tuberous sclerosis complex and refractory status epilepticus.
Marinus Pharmaceuticals (Nasdaq: MRNS) has partnered with Orion Corporation to commercialize ganaxolone for treating seizure disorders in Europe. Orion will pay Marinus €25 million (~$30 million) upfront, with potential additional payments of up to €97 million (~$115 million) based on research and development milestones. Marinus retains responsibility for clinical development and regulatory approvals, including an application for marketing authorization anticipated by Q3 2021. Ganaxolone, which exhibits anti-seizure effects, has a projected 10 years of regulatory data protection in Europe.
Marinus Pharmaceuticals (MRNS) announced the submission of a New Drug Application (NDA) to the FDA for ganaxolone, aimed at treating seizures linked to CDKL5 deficiency disorder (CDD). The NDA is backed by Phase 3 trial data indicating a 30.7% reduction in seizure frequency. If accepted, Marinus can access $30 million in funding under a credit agreement. The company also plans a marketing application for Europe and has secured a partnership with Orion Corporation for further commercialization, enhancing its market reach.
Marinus Pharmaceuticals (Nasdaq: MRNS) announces the appointment of Dr. Santiago Arroyo to its Board of Directors. With over 30 years in academic neurology and pharma R&D, Dr. Arroyo is expected to enhance Marinus' pipeline as it focuses on seizure disorders. Previously, he held key roles at Momenta and Pfizer, and has experience in clinical trials for epilepsy treatments. Concurrently, Dr. Enrique J. Carrazana steps down after eight years, having contributed significantly to the company's development.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced the grant of inducement awards to five new employees, comprising non-qualified stock options for 29,063 shares. The options have an exercise price of $18.50 per share, equivalent to the closing stock price on June 18, 2021. Vesting occurs as 25% becomes exercisable after one year, with the remaining 75% vesting monthly over three years, contingent on continued employment. Marinus focuses on innovative treatments for seizure disorders, including ongoing clinical trials for ganaxolone, a therapeutic agent for various seizure conditions.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced the grant of inducement stock options totaling 57,310 shares to seven new employees, approved by its Compensation Committee in line with Nasdaq rules. The options include 36,310 shares at an exercise price of $14.34 per share, and 21,000 shares at $14.15. Vesting occurs over a four-year period, with 25% on the one-year anniversary and the rest monthly thereafter. Marinus focuses on innovative therapies for seizure disorders, with ongoing clinical trials for its lead product, Ganaxolone, aimed at various epilepsy-related conditions.
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