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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 (MRNS) has received significant regulatory advances for ganaxolone, including the European Medicines Agency's acceptance of its Marketing Authorization Application for CDKL5 deficiency disorder and orphan drug designation for tuberous sclerosis complex. The company aims to commercialize ganaxolone by mid-2022, with patient enrollment in key trials set to begin in early 2022. Financially, Marinus reported a net loss of $19.5 million for Q3 2021, with cash resources of $145.1 million. Guidance for BARDA revenues is now between $6 to $8 million, reflecting a slight decrease from previous estimates.
Marinus Pharmaceuticals (NASDAQ: MRNS) has announced the grant of inducement awards to five new employees, comprising non-qualified stock options to purchase a total of 59,435 shares of common stock. The options have an exercise price of $12.72 per share, aligned with the closing price on November 4, 2021. The vesting schedule allows for 25% of shares to be exercised after one year, with the remaining 75% vesting monthly over three years. This initiative aims to attract talent while adhering to Nasdaq Listing Rule 5635(c)(4).
Marinus Pharmaceuticals (MRNS) is set to release its third-quarter financial results on November 9, 2021, before market opening. The company will hold a conference call at 8:30 a.m. ET to discuss its financial performance and business updates. Marinus focuses on developing therapeutics for rare seizure disorders, particularly Ganaxolone, which acts on GABAA receptors. The company has made significant progress with trials, including a pivotal Phase 3 trial in CDKL5 deficiency disorder and ongoing studies in other seizure-related conditions.
Marinus Pharmaceuticals (MRNS) has partnered with the Loulou Foundation and six biotech organizations to conduct a three-year observational study, CANDID, focusing on CDKL5 deficiency disorder (CDD). This study aims to explore the natural history of CDD and the effectiveness of various clinical assessments. Marinus is progressing with its investigational drug ganaxolone for CDD, with the FDA giving priority review to its New Drug Application, set for a decision by March 20, 2022. The drug has shown promising results in trials, with significant reductions in seizure frequency.
Marinus Pharmaceuticals announced the grant of inducement stock options to five new employees, totaling 33,998 shares at an exercise price of $11.75 per share, equal to the closing price on October 7, 2021. These options will vest over four years, starting with 25% on the one-year anniversary of employment. This is aimed at attracting talent in accordance with Nasdaq Listing Rule 5635(c)(4). Marinus is focused on developing therapeutics for seizure disorders, with ongoing clinical trials for its lead product, Ganaxolone.
Marinus Pharmaceuticals (MRNS) will present updates on its pipeline and commercial plans in a virtual R&D event today at 9 AM ET. Key highlights include advancing clinical trials for ganaxolone, focusing on CDKL5 deficiency disorder (CDD), tuberous sclerosis complex (TSC), and status epilepticus (SE). The marketing authorization application for CDD is expected to be validated by the EMA by the end of October, with a PDUFA date for the FDA set for March 20, 2022. Additionally, they plan the commercial launch of Ztalmy®, a proposed oral ganaxolone treatment.
Marinus Pharmaceuticals (MRNS) will host a virtual R&D event on October 5, 2021, from 9:00 a.m. to 12:00 p.m. Eastern Time. Key executives will present insights on the company’s clinical development programs, commercial strategies, and pipeline expansions. Topics include updates on the IV ganaxolone program for status epilepticus and plans for a Phase 3 trial in tuberous sclerosis complex. The event is open for investor registration, and a replay will be available on the company website.
Marinus Pharmaceuticals (MRNS) announced that the FDA has accepted its New Drug Application (NDA) for ganaxolone to treat seizures associated with CDKL5 deficiency disorder (CDD). The NDA has been granted a Priority Review designation with a PDUFA action date set for
Marinus Pharmaceuticals (MRNS) has granted inducement awards to five new employees, comprising non-qualified stock options for 14,313 shares at an exercise price of
Marinus Pharmaceuticals (MRNS) announced that the EMA's CHMP has granted accelerated assessment for ganaxolone, aimed at treating seizures related to CDKL5 deficiency disorder (CDD). This designation highlights ganaxolone's therapeutic potential for addressing unmet medical needs. The company plans to submit a marketing authorization application by Q3 2021, supported by data from the Phase 3 Marigold trial, which showed a 30.7% median reduction in seizure frequency. If approved, ganaxolone could quickly enter European markets through collaboration with Orion Corporation.
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