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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 unveiled a new brand identity symbolizing its commitment to patients and innovation in treating rare seizure disorders. The updated logo features interconnected rings representing various patient communities. Chief Commercial Officer Christy Shafer emphasized the company's evolution as a late-stage pharmaceutical entity. Marinus is enhancing its outreach through revamped communication channels, including its website and social media platforms, to raise awareness about its therapies and ongoing clinical programs, including pivotal trials for ganaxolone.
Marinus Pharmaceuticals (Nasdaq: MRNS) will present at key healthcare conferences, showcasing its commitment to treating rare seizure disorders. CEO Scott Braunstein, M.D., and CMO Joseph Hulihan, M.D., are scheduled to speak during the 10th Annual SVB Leerink Global Healthcare Conference on February 25 at 1:40 PM EST, followed by the Cowen 41st Annual Health Care Conference on March 1 at 10:20 AM EST. Additional presentations will occur at the H.C. Wainwright Global Life Sciences Conference on March 9 at 3:00 PM EST, and the Oppenheimer 31st Annual Healthcare Conference on March 16 at 8:00 AM EST.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) announced the grant of inducement awards to five new employees, comprising non-qualified stock options for a total of 72,500 shares. The exercise prices range from $12.60 to $12.67 per share based on recent closing prices. These options will vest 25% after one year, with the remaining 75% vesting monthly over the next three years. Marinus is engaged in developing innovative therapeutics for rare seizure disorders, with ongoing Phase 3 and Phase 2 clinical trials for its lead product, ganaxolone.
Marinus Pharmaceuticals, Inc. (MRNS) plans to release its financial results for Q4 and FY 2020 on March 9, 2021, before the market opens. A conference call is scheduled for the same day at 8:30 AM ET to discuss these results and provide a business update. The company focuses on developing therapeutics for rare seizure disorders, with its lead product, Ganaxolone, proceeding through various clinical trials, including Phase 3 for status epilepticus and trials for CDKL5 deficiency disorder and tuberous sclerosis complex.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) has initiated the enrollment of the first patient in a Phase 3 clinical trial for IV ganaxolone (RAISE trial) aimed at treating refractory status epilepticus (RSE), a critical condition involving severe, prolonged seizures. This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of IV ganaxolone in patients who have not responded to standard treatments. The trial plans to include approximately 125 patients across 80 U.S. hospitals and is partially funded by BARDA.
Marinus Pharmaceuticals (Nasdaq: MRNS) received positive feedback from the FDA on the data from its pivotal Phase 3 Marigold Study for oral ganaxolone, aimed at treating children and young adults with CDKL5 deficiency disorder (CDD). The FDA deemed the efficacy and safety data sufficient to consider a New Drug Application (NDA) submission. The Marigold Study demonstrated a 32.2% reduction in major motor seizure frequency in patients treated with ganaxolone, achieving its primary endpoint. Marinus plans to hold a pre-NDA meeting by Q1's end and submit the NDA by mid-2021.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced its participation in two major healthcare conferences. Management will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 3:40 pm EST. Additionally, they will join the H.C. Wainwright Bioconnect 2021 Conference starting January 11, 2021, at 6:00 am EST. Key speakers include CEO Scott Braunstein, CFO Edward Smith, and CMO Joseph Hulihan. Webcasts will be available post-event on the company’s website.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) announced its inclusion in the Nasdaq Biotechnology Index (NBI), effective today. CEO Scott Braunstein emphasized that this recognition reflects the company's clinical progress and increasing investor awareness as they advance their pipeline targeting rare epilepsy and neuropsychiatric disorders. Marinus is focused on ganaxolone, a GABAA receptor modulator, which is being developed in various formulations for both adult and pediatric patients. They are conducting multiple clinical trials, including a pivotal Phase 3 trial for children with CDKL5 deficiency disorder.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced an underwritten public offering of 5 million shares of common stock, aiming for gross proceeds of $70 million. The offering is expected to close around December 10, 2020, pending customary conditions. Cantor Fitzgerald is the sole bookrunner, with H.C. Wainwright as lead manager. Proceeds will support product candidate development and general corporate needs. The shares are offered under a shelf registration statement effective July 27, 2020. The last reported share price was $15.61 on December 7, 2020.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced an underwritten public offering of its common stock, with all shares offered by the company. The underwriters have a 30-day option to purchase an additional 15% of the offering. Cantor Fitzgerald & Co. is the sole bookrunner. Proceeds will fund product development and general corporate needs, including capital expenditures and clinical trials. The offering will utilize a shelf registration statement effective since July 27, 2020. This press release does not constitute an offer to sell or solicit an offer to buy securities.
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