Welcome to our dedicated page for Marinus Pharmace news (Ticker: MRNS), a resource for investors and traders seeking the latest updates and insights on Marinus Pharmace stock.
Marinus Pharmaceuticals (MRNS) is a clinical-stage biopharma company advancing ganaxolone for rare neurological disorders, including epilepsy and CDKL5 deficiency disorder. This page aggregates official announcements and verified updates about the company's therapeutic developments and regulatory progress.
Investors and researchers will find timely updates on clinical trial outcomes, FDA designations, and strategic partnerships. Our curated collection ensures access to primary source materials including press releases, regulatory filings, and milestone achievements.
Key content includes updates on ganaxolone's development pathway, orphan drug status details, and analyses of the company's position in neurotherapeutics. All materials are sourced directly from company communications to ensure accuracy.
Bookmark this page for streamlined tracking of MRNS's progress in addressing high-need neurological conditions through innovative therapeutic development.
Marinus Pharmaceuticals (Nasdaq: MRNS) will host an Investor and Analyst Day on September 20, 2024, from 9:00 a.m. to 12:00 p.m. Eastern Time in New York and via webcast. The event will focus on the company's development program for ZTALMY® (ganaxolone) oral suspension CV in tuberous sclerosis complex (TSC). Presentations will be given by Marinus management and key opinion leaders, with emphasis on the upcoming Phase 3 TrustTSC trial data readout expected in the first half of Q4 2024.
In-person attendance is to invited research analysts and institutional investors, while others can watch the live video webcast. Registration for the webcast is available on the company's Investor Relations website. A replay will be archived following the event.
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.
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