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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) announced a virtual Scientific Exhibit at the American Epilepsy Society Annual Meeting, featuring 10 posters on clinical programs for CDKL5 deficiency disorder (CDD) and refractory status epilepticus (RSE). Key highlights include latest analyses from the Phase 3 Marigold Study showing significant reductions in seizure frequency with ganaxolone across various patient subgroups. The company is also launching an expanded access program for CDD patients and plans to meet with the FDA in Q1 2021 regarding NDA submissions.
Marinus Pharmaceuticals (Nasdaq: MRNS) hosted a virtual Scientific Exhibit at the American Epilepsy Society Annual Meeting, featuring 10 posters on its clinical development programs for CDKL5 deficiency disorder (CDD) and refractory status epilepticus (RSE). Key highlights included data from the Phase 3 Marigold Study, demonstrating significant seizure reduction in CDD patients treated with ganaxolone, with a median reduction of 52.7% over 12 months. The company plans to meet with the FDA in Q1 2021 regarding its NDA submission for CDD and has launched an expanded access program for ganaxolone.
Marinus Pharmaceuticals (MRNS) has launched an expanded access program (EAP) to provide ganaxolone to patients with CDKL5 Deficiency Disorder (CDD) who did not participate in the Phase 3 Marigold Study. The decision comes after the trial demonstrated a significant 32.2% reduction in major motor seizures compared to 4.0% for placebo. Marinus plans to submit a new drug application to the FDA in mid-2021. The EAP is initially available in the US, targeting patients aged two and older suffering from uncontrollable seizures.
Marinus Pharmaceuticals, Inc. (MRNS) announced the grant of inducement awards to two new employees, comprising non-qualified stock options for 10,000 shares. The exercise price is set at $14.54 per share, matching the closing price on December 3, 2020. These options will vest 25% on the one-year anniversary of employment and the remaining 75% in monthly installments over three years, contingent on ongoing employment. Marinus focuses on innovative treatments for rare seizure disorders, with its lead product, ganaxolone, undergoing multiple clinical trials.
Marinus Pharmaceuticals (Nasdaq: MRNS) will host a webinar on December 7, from 12:00 PM to 2:00 PM ET, providing a clinical update on its pipeline addressing rare seizure disorders. Key topics include Status Epilepticus, CDKL5 Deficiency Disorder, and Tuberous Sclerosis Complex. The event features expert presentations, including insights from Dr. Elia M. Pestana Knight, and discussions on caregiver experiences and commercial strategy. This initiative aims to enhance understanding of Marinus’ therapies and pipeline.
Marinus Pharmaceuticals (MRNS) announced the selection of four abstracts focusing on clinical trial data for ganaxolone at the American Epilepsy Society Annual Meeting (AES2020), occurring from December 4-8, 2020. Highlights include results from the pivotal Marigold Phase 3 study in CDKL5 deficiency disorder and the use of ganaxolone in refractory status epilepticus. Additionally, six other posters related to Marinus will be presented during a virtual Scientific Exhibit on December 7, showcasing the drug's extensive therapeutic potential.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) announces the grant of 134,000 stock options to two new employees as inducement for their employment. The options, priced at $13.71 per share, will vest 25% on the one-year anniversary of employment and the remainder in 36 monthly installments, contingent on continued employment. Marinus focuses on developing innovative therapies for rare seizure disorders, with its lead candidate, Ganaxolone, undergoing multiple clinical trials.
Marinus Pharmaceuticals (Nasdaq: MRNS) reported its Q3 2020 results, highlighting significant milestones in its clinical programs. Notably, the Phase 3 Marigold Study demonstrated a 32.2% median reduction in major motor seizures in patients with CDKL5 Deficiency Disorder (CDD) using ganaxolone. The company has secured a cost-sharing contract with BARDA for its refractory status epilepticus program. Financially, Marinus reported a net loss of $15.7 million for Q3, with cash reserves of $91.3 million, sufficient to fund operations into 2022. NDA submission for CDD is anticipated in mid-2021.
Marinus Pharmaceuticals (MRNS) has appointed Christy Shafer as Chief Commercial Officer. Reporting to CEO Scott Braunstein, Shafer brings two decades of experience in biotech and pharmaceuticals, with expertise in neurology and commercial strategy. Her leadership is expected to enhance the commercial launch of ganaxolone, particularly for CDKL5 deficiency disorder. The company recently completed a pivotal Phase 3 trial for ganaxolone and is focused on expanding its clinical trials in related conditions. This strategic hire is aimed at driving growth and maximizing the drug's market potential.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) will release its financial results for Q3 2020 on November 9, 2020, after market close. A conference call will be held at 4:30 PM ET on the same day to discuss the results and provide a business update. The company focuses on developing innovative therapies for rare seizure disorders, such as Ganaxolone, which targets GABAA receptors. Marinus recently completed a Phase 3 trial in children with CDKL5 deficiency disorder and plans further trials in related conditions.
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