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) has priced its public offering of 10,526,316 shares of common stock at $4.75 per share, raising approximately $60 million in gross proceeds. The offering includes pre-funded warrants for an additional 2,105,264 shares at $4.749 each. A 30-day option for underwriters to purchase up to 1,894,737 additional shares has also been granted. Proceeds will be used for commercialization of ZTALMY® (ganaxolone), development of product candidates, and general corporate purposes. The offering is set to close on November 10, 2022, with customary closing conditions.
Marinus Pharmaceuticals (MRNS) has launched an underwritten public offering of its securities, with plans to grant underwriters a 30-day option to purchase an additional 15% of the offered amount. The company will use net proceeds to fund the commercialization of ZTALMY® (ganaxolone) and support ongoing development efforts. The offering is under a registration statement filed with the SEC and is subject to market conditions. SVB Securities, RBC Capital Markets, and Cantor Fitzgerald & Co. are the joint bookrunners for this offering.
Marinus Pharmaceuticals (MRNS) reported strong performance following the U.S. launch of ZTALMY® (ganaxolone) on July 28, achieving $0.56 million in net product revenue for Q3 2022 with over 50 prescription enrollments for CDKL5 deficiency disorder (CDD). Approximately 40% were on reimbursed therapy by Q3-end. The company secured favorable coverage from over 15 payers, impacting around 70 million lives. Cash runway extends into Q1 2024 due to a $110 million Priority Review Voucher sale and $32.5 million revenue interest financing. Phase 3 clinical trials are actively recruiting, with data expected in late 2023 and early 2024.
Marinus Pharmaceuticals has secured
Marinus Pharmaceuticals, Inc. (MRNS) announced plans to release its third-quarter financial results on November 8, 2022, before U.S. market opening. A conference call will follow at 8:30 a.m. ET, accessible via the Investor page on Marinus' website. Marinus focuses on developing innovative therapeutics for seizure disorders, with its product ZTALMY® approved for treating seizures associated with CDKL5 deficiency disorder. The company is also exploring ganaxolone's potential in other seizure disorders through ongoing Phase 3 trials.
Marinus Pharmaceuticals (NASDAQ: MRNS) announced the grant of 46,999 non-qualified stock options to five new employees, as approved by its Compensation Committee. The options, priced at $5.78 per share, will vest over four years, with 25% vesting after the first year and the remainder in equal monthly installments. This grant is intended as an inducement for the employees in accordance with Nasdaq Listing Rule 5635(c)(4). Marinus focuses on developing innovative therapeutics for seizure disorders, notably its product ZTALMY® for CDKL5 deficiency disorder.
Marinus Pharmaceuticals (Nasdaq: MRNS) has announced that four abstracts regarding ganaxolone for seizure disorders have been accepted for poster presentations at medical meetings in October. The presentations will occur at the 51st Child Neurology Society Annual Meeting in Cincinnati from October 12-15 and the Neocritical Care Society Annual Meeting in San Antonio from October 17-21. Marinus's ganaxolone is FDA-approved for CDKL5 deficiency disorder and is being evaluated for additional seizure disorders through ongoing Phase 3 trials.
Marinus Pharmaceuticals (NASDAQ: MRNS) announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised a contract option worth approximately $12.3 million to support U.S. onshoring of ganaxolone's active pharmaceutical ingredient (API) manufacturing. This exercise is part of a larger contract awarded in 2020, with total potential funding of $51 million if all options are exercised. This agreement strengthens the partnership with BARDA and aims to enhance treatment capabilities for refractory status epilepticus (RSE), a severe seizure condition.
Marinus Pharmaceuticals (NASDAQ: MRNS) has granted inducement awards to nine new employees, consisting of non-qualified stock options to purchase a total of 68,050 shares of common stock. The options have an exercise price of $6.61 per share, reflecting the closing price on September 8, 2022. These options will vest over a four-year period, with 25% vesting after one year and the remaining 75% vesting in monthly installments. Marinus focuses on developing innovative therapeutics for seizure disorders, with its product ZTALMY® approved for treating seizures in CDKL5 deficiency disorder.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced its participation in two key investor conferences this September. The company will present at the Baird 2022 Global Healthcare Conference in New York on September 13 at 2:35 p.m. ET, and at the H.C. Wainwright 24th Annual Global Investment Conference on September 14 at 12:00 p.m. ET. Interested parties can access event links on the company’s Investors & Media page. A replay of the presentations will be available shortly after each event.
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