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 (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.
Marinus Pharmaceuticals (NASDAQ: MRNS) announced the sale of its Rare Pediatric Disease Priority Review Voucher for $110 million. The funds received are in addition to $92.3 million in cash as of June 30, 2022. Proceeds will support the launch of ZTALMY® and fund Phase 3 clinical programs for refractory status epilepticus and tuberous sclerosis complex, ensuring financial stability through Q4 2023. Jefferies LLC served as the exclusive financial advisor for the transaction.
Marinus Pharmaceuticals (NASDAQ: MRNS) has announced the grant of inducement awards consisting of non-qualified stock options for 57,975 shares to seven new employees. The exercise price of these options is $5.47 per share, matching the closing share price on August 9, 2022. The options will vest in increments, starting with 25% after one year and the remaining 75% over the next three years, contingent on continued employment. Marinus focuses on innovative therapies for seizure disorders, including its FDA-approved product, ZTALMY®, and ongoing Phase 3 trials for other conditions.
Marinus Pharmaceuticals (MRNS) announced that ZTALMY® is now available for prescription in the U.S. The second-generation ganaxolone formulation showed promising Phase 1 results, supporting further development.
Key updates include protocol amendments for the Phase 3 RAISE trial to enhance recruitment, with data expected in 2H 2023. Marinus completed a $110 million sale of a Priority Review Voucher, strengthening its cash position. The company reported a net loss of $39.4 million for Q2 2022, with cash reserves at $92.3 million.
Marinus Pharmaceuticals has launched ZTALMY® (ganaxolone) oral suspension, the first FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD) in patients aged two years and older. This launch follows FDA approval in March 2022, based on a Phase 3 trial showing a median reduction in monthly major motor seizures by 30.7%. The company has established ZTALMY One™, a comprehensive patient support program to facilitate access to the medication, including financial aid for patients with limited insurance. ZTALMY is a GABAA receptor modulator taken three times daily.
Marinus Pharmaceuticals (NASDAQ: MRNS) announced the grant of inducement awards to 13 new employees, including non-qualified stock options for 132,375 shares and restricted stock units for 20,500 shares. The stock options have an exercise price of $5.26, reflecting the closing price on July 14, 2022. The options vest 25% on the one-year anniversary of employment and the remaining 75% in 36 monthly installments. The restricted stock units fully vest after one year. This move complies with Nasdaq Listing Rule 5635(c)(4), aiming to attract top talent.
Marinus Pharmaceuticals (NASDAQ: MRNS) has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $110 million. This transaction is expected to enhance Marinus' financial position, extending its cash runway into the fourth quarter of 2023. The PRV was received in March 2022 after the FDA approved ZTALMY for treating seizures associated with CDKL5 deficiency disorder. The lump sum payment is subject to customary closing conditions and antitrust clearance requirements.
Marinus Pharmaceuticals (MRNS) plans to release its second-quarter financial results for the period ending June 30, 2022, before U.S. market open on August 11, 2022. The company will host a conference call at 8:30 a.m. ET the same day. Marinus is focused on developing innovative therapeutics for seizure disorders, with its product ZTALMY (ganaxolone) approved for treating seizures associated with CDKL5 deficiency disorder. Ganaxolone is also under investigation for other conditions in Phase 3 trials.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced an amendment to the Phase 3 RAISE trial protocol for refractory status epilepticus, expanding eligibility criteria to enhance patient recruitment. The updated protocol allows patients previously treated with IV anesthesia to participate, aligning with FDA approval. The company targets activation of 10 new sites in Canada by Q3 2022, aiming for 65-75 sites globally, and anticipates topline data in late 2023. Funding for the ganaxolone development is partially provided by BARDA.
Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) announced the grant of inducement stock options to 11 new employees, totaling 116,625 shares at an exercise price of $5.22, equal to the closing stock price on June 2, 2022. These options will vest over time, starting with 25% on the one-year anniversary of the employees’ start dates. The grant adheres to Nasdaq Listing Rule 5635(c)(4) and aims to attract talent in the company's mission to develop therapeutics for seizure disorders.
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