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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. (NASDAQ: MRNS) will release its fourth-quarter financial results for the period ending December 31, 2022, on March 7, 2023. The company will conduct a conference call at 4:30 p.m. Eastern Time on the same day, accessible via its Investor page. Marinus focuses on innovative therapeutics for seizure disorders, including its FDA-approved product ZTALMY® (ganaxolone) for CDKL5 deficiency disorder. This neuroactive steroid is also being studied in Phase 3 trials for tuberous sclerosis complex and refractory status epilepticus, aiming to enhance treatment options for both adults and pediatric patients.
Marinus Pharmaceuticals (MRNS) announced the grant of stock options to five new employees, totaling 57,900 shares. The options have an exercise price of $6.71 per share, matching the closing stock price on February 7, 2023. Vesting is scheduled to occur with 25% on the one-year anniversary of employment and the remaining 75% in monthly installments over three years. This grant is in line with Nasdaq Listing Rule 5635(c)(4), emphasizing the company's commitment to attracting talent in the pharmaceutical sector. Marinus continues to develop its lead product, ZTALMY® (ganaxolone), for seizure disorders.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced its participation in several upcoming conferences aimed at advancing innovative therapeutics for seizure disorders. Key presentations include the SVB Securities Global Biopharma Conference on February 15 at 2:20 p.m. E.T., the Cowen 43rd Annual Health Care Conference on March 6 at 12:50 p.m. E.T., and the Oppenheimer 33rd Annual Healthcare Conference on March 14 at 4:00 p.m. E.T.. Webcast replays will be available post-event. Marinus is known for its FDA-approved product, ZTALMY (ganaxolone), targeting seizures associated with CDKL5 deficiency disorder.
Marinus Pharmaceuticals (NASDAQ: MRNS) announced the appointment of Christine Silverstein to its Board of Directors and Audit Committee. Silverstein brings expertise in capital markets, strategic planning, and risk management, enhancing Marinus' ability to advance its ZTALMY (ganaxolone) franchise and clinical pipeline. Currently serving as CFO at Excision Biotherapeutics, she has held senior roles in various biopharmaceutical companies. Her financial acumen and background in neurology positioning her well to aid in the growth of therapeutic solutions for seizure disorders.
Marinus Pharmaceuticals (MRNS) announced the grant of inducement awards to two new employees, comprising non-qualified stock options for 20,400 shares at an exercise price of
Marinus Pharmaceuticals (NASDAQ: MRNS) reported preliminary fiscal results for ZTALMY® net product revenue in Q4 2022, estimating between
Marinus Pharmaceuticals (MRNS) announced the presentation of ganaxolone data at the 2022 American Epilepsy Society Annual Meeting from December 2-6 in Nashville, TN. Key presentations include pharmacokinetics related to ganaxolone and cannabidiol, and long-term treatment data for CDKL5 deficiency disorder. Marinus will host a scientific exhibit and an investor breakfast on December 5, discussing ganaxolone's potential in treating various seizure disorders and its commercial strategies.
Marinus Pharmaceuticals (MRNS) announced the grant of stock options totaling 71,700 shares to three new employees. The options have an exercise price of $4.98 per share, aligned with the stock's closing price on November 14, 2022. Vests will occur at 25% on the one-year anniversary of employment and the remaining 75% over the following 36 months, contingent upon continued employment. Marinus focuses on innovative therapies for seizure disorders, with its leading product, ZTALMY, approved for treating CDKL5 deficiency disorder and undergoing trials for other seizure conditions.
Marinus Pharmaceuticals has entered a collaboration with Tenacia Biotechnology to develop ganaxolone in China and other regions. Marinus will receive an upfront payment of $10 million and is eligible for up to $256 million in potential milestone payments along with tiered royalties on net sales. The partnership aims to enhance ganaxolone's reach for treating seizure disorders through Tenacia's expertise in the CNS market. This collaboration highlights Marinus's strategy to expand its global access and support ongoing development programs for rare epilepsy conditions.
Marinus Pharmaceuticals (NASDAQ: MRNS) announced the appointment of Scott Braunstein, M.D., as Chairman of the Board, succeeding Nicole Vitullo, who retired after 17 years. Alongside this change, Michael Dougherty also retired from the Board, and Santiago Arroyo stepped down to become Chief Medical Officer at another company. The Board is searching for new directors. Tim M. Mayleben, Lead Independent Director, commended the company's growth and Braunstein's leadership, citing the U.S. approval and launch of ZTALMY, a treatment for seizure disorders. Braunstein aims to enhance the Board's capabilities and advance their clinical pipeline.
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