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 provided a business update and reported financial results for Q2 2024.
ZTALMY® (ganaxolone) achieved net product revenue of $8.0 million, up 87% from Q2 2023, with full-year guidance between $33-$35 million.
Enrollment in the Phase 3 TrustTSC trial is complete, with topline data expected in early Q4 2024. Global footprint expansion continues with approvals in China, EU, and UK, and upcoming launches in Europe and China.
Financial highlights include a net loss of $35.8 million for Q2, with cash reserves of $64.7 million. Cost reduction plans are set to cut SG&A and R&D expenses by 30% in H2 2024.
Notably, Marinus succeeded in a patent challenge against Ovid Therapeutics' U.S. Patent, and plans to discuss next steps for IV ganaxolone with the FDA.
Marinus Pharmaceuticals (Nasdaq: MRNS), a company focused on developing innovative therapeutics for seizure disorders, has announced its plans to release second quarter 2024 financial results on August 13, 2024. The company will host a conference call at 8:30 a.m. E.T. on the same day to provide a business update and discuss the financial results. Investors can join the call using domestic (877-405-1242) or international (201-389-0852) dial-in numbers. A webcast of the call will also be available, and an archived version will be accessible on the Marinus website approximately two hours after the event concludes.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced that the China National Medical Products Administration (NMPA) has approved ganaxolone oral suspension for treating epileptic seizures in patients two years and older with CDKL5 Deficiency Disorder (CDD). This approval is based on data from the Phase 3 Marigold trial, which showed a 30.7% median reduction in 28-day major motor seizure frequency for ganaxolone-treated patients compared to 6.9% for placebo. The approval marks the first treatment option for CDD patients in China.
Marinus' partner, Tenacia Biotechnology, will commercialize ganaxolone in Mainland China, Hong Kong, Macau, and Taiwan. The collaboration agreement includes royalties and payments tied to net sales and milestones. Ganaxolone has now received regulatory approval for CDD in the U.S., European Union, and China.
Marinus Pharmaceuticals announced topline results from the Phase 3 RAISE trial for IV ganaxolone in treating refractory status epilepticus (RSE). The trial met its first co-primary endpoint by achieving rapid cessation of status epilepticus in 80% of patients compared to 13% in the placebo group. However, it failed to meet the second endpoint of preventing the need for IV anesthesia within 36 hours.
Despite these mixed results, Marinus plans to continue focusing on its ZTALMY franchise and expanding into chronic epilepsies. The company also implemented cost reduction measures, projecting a cash runway into Q2 2025. The full RAISE dataset will be further analyzed, and discussions with the FDA are planned to explore next steps for IV ganaxolone.
Marinus Pharmaceuticals has completed enrollment in its Phase 3 TrustTSC trial, evaluating ganaxolone for treating seizures associated with tuberous sclerosis complex (TSC) in children and adults. This trial enrolled highly refractory TSC patients, most of whom have been treated with multiple antiseizure medications. The goal is to reduce somnolence-related adverse events, and only 2% of participants discontinued due to such events. Topline data from the trial is expected in early Q4 2024, with a supplemental New Drug Application (sNDA) submission targeted for April 2025. Additionally, the USPTO has granted Marinus a new method of use patent for ganaxolone in TSC treatment, expiring in 2040.
Marinus Pharmaceuticals reported a 125% growth in Q1 2024 net product revenue to $7.5 million compared to Q1 2023. Full-year 2024 US ZTALMY net product revenue projected between $33 and $35 million. Plans to announce RAISE trial results in summer 2024 and engage with the FDA for potential filing. Implemented cost reduction measures to extend cash runway into late Q1 2025 with $113.3 million in cash, cash equivalents, and short-term investments as of March 31, 2024.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) will have its Chairman and CEO, Dr. Scott Braunstein, participating in a fireside chat at the RBC Capital Markets 2024 Global Healthcare Conference on May 15 at 1:35 p.m. Eastern Time. The event will be accessible through Marinus' website, with a replay available for 90 days.
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) will provide a business update and report its first quarter 2024 financial results on May 8, 2024. The company focuses on developing therapeutics to treat seizure disorders.
FAQ
What is the current stock price of Marinus Pharmaceuticals (MRNS)?
What is the market cap of Marinus Pharmaceuticals (MRNS)?
What is Marinus Pharmaceuticals, Inc.?
What is ganaxolone?
What is CDKL5 disorder?
What does orphan drug designation mean?
Which other conditions is ganaxolone being developed for?
When did Marinus receive orphan drug designation for ganaxolone?
What incentives does orphan drug designation provide?
What is the primary area of focus for Marinus Pharmaceuticals?
Why is ganaxolone significant?
How does Marinus Pharmaceuticals impact patient care?
