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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 (MRNS) reported Q3 2024 financial results with ZTALMY net product revenue of $8.5 million, showing 56% growth versus Q3 2023. The company narrowed its 2024 ZTALMY revenue guidance to $33-34 million. Following unsuccessful Phase 3 trial results, Marinus has suspended further ganaxolone clinical development and implemented cost reductions, including a 45% workforce reduction. The company reported cash and cash equivalents of $42.2 million as of September 30, 2024, expected to fund operations into Q2 2025. Marinus has initiated a process to explore strategic alternatives to maximize stockholder value while supporting ZTALMY's commercial growth.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced that its Phase 3 TrustTSC trial evaluating oral ganaxolone for treating tuberous sclerosis complex (TSC)-associated seizures failed to meet its primary endpoint. While the ganaxolone group showed a 19.7% median reduction in seizure frequency compared to 10.2% for placebo, the results weren't statistically significant (p=0.09). Following this outcome, Marinus is discontinuing further ganaxolone development, implementing cost reductions including workforce cuts, and exploring strategic alternatives with Barclays as advisor. The company will continue supporting ZTALMY®, its FDA-approved treatment for CDKL5 deficiency disorder, which currently treats over 200 patients.
Marinus Pharmaceuticals (Nasdaq: MRNS) presented new data from its pivotal Phase 3 RAISE trial evaluating intravenous (IV) ganaxolone for refractory status epilepticus (RSE) at the Neurocritical Care Society Annual Meeting. The trial met one of two co-primary endpoints:
1. 80% of patients achieved status epilepticus (SE) cessation within 30 minutes with IV ganaxolone vs. 13% with placebo (p<0.0001).
2. The trial failed to achieve statistical significance in preventing progression to IV anesthesia for 36 hours (63% vs. 51%, p=0.162).
Secondary endpoints showed promising results, including a median time to SE cessation of 4.2 minutes for IV ganaxolone vs. 307.2 minutes for placebo, and a 93% median reduction in EEG seizure burden through 36 hours vs. 36% for placebo. The safety profile was similar between treatment arms, with hypotension more common in the IV ganaxolone group.
Marinus Pharmaceuticals has strengthened its intellectual property estate with a new U.S. patent for ZTALMY® (ganaxolone) oral titration regimens. The patent covers treatment for various epilepsy disorders, including CDKL5 deficiency disorder, tuberous sclerosis complex (TSC), and Lennox-Gastaut syndrome (LGS). It expires in September 2042.
The new patent (U.S. patent No. 12,115,169) further protects ZTALMY and supports Marinus' development and commercialization plans for ganaxolone in TSC and other areas of high unmet need. The company's patent portfolio reflects decades of research and scientific innovation, backed by robust data on ganaxolone's pharmacology and effective clinical dosing.
Marinus believes that the revised ganaxolone titration schedule has the potential to significantly impact tolerability, compliance, and lead to improved patient outcomes in various epilepsy disorders.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced upcoming presentations at the Neurocritical Care Society 22nd Annual Meeting, October 14-17 in San Diego. The presentations will feature:
- Additional data from the Phase 3 RAISE trial on intravenous ganaxolone for refractory status epilepticus
- A retrospective claims-based analysis on status epilepticus management
Key presentations include:
- A podium presentation on October 17 by Dr. Brandon Foreman, discussing efficacy and safety results from the RAISE trial
- A poster presentation on October 16 by Dr. Henrikas Vaitkevicius, focusing on challenges in status epilepticus management, particularly high rates of interhospital transfers
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a company focused on developing innovative therapeutics for seizure disorders, has announced the grant of inducement awards to a new employee. The Compensation Committee approved non-qualified stock options to purchase 9,800 shares of common stock, with an exercise price of $1.85 per share, equal to the closing price on October 7, 2024.
The stock options will vest as follows:
- 25% of the shares on the one-year anniversary of the employee's start date
- The remaining 75% in 36 equal monthly installments thereafter
These grants were made in accordance with Nasdaq Listing Rule 5635(c)(4) as an inducement for employment and are subject to the terms of the applicable award agreement.
Marinus Pharmaceuticals is hosting an Investor and Analyst Day to present progress on ZTALMY® (ganaxolone) for tuberous sclerosis complex (TSC). Key highlights include:
1. TrustTSC Phase 3 trial topline data expected in Q4 2024, with NDA filing targeted for April 2025.
2. Low discontinuation rate (6.2%) in TrustTSC trial, with 93% of patients continuing to open-label extension.
3. Phase 2 TSC trial long-term extension showed 56% median seizure frequency reduction within two years.
4. Real-world data indicates 26% of TSC patients have tried and failed 3+ antiseizure medications.
5. New patent allowance for ganaxolone oral titration regimens, expected to run through September 2042.
6. On track for 2024 ZTALMY net product revenue of $33-35 million.
7. Targeting total company profitability within 18 months of U.S. TSC launch.
Marinus Pharmaceuticals (Nasdaq: MRNS) has announced the agenda and speakers for its Investor & Analyst Day on September 20, 2024. The event will focus on the development and commercial launch preparations for ZTALMY® (ganaxolone) in tuberous sclerosis complex (TSC). Key highlights include:
1. Updated baseline patient demographics from the Phase 3 TrustTSC trial
2. Market opportunity in TSC
3. New open label extension data from the Phase 2 TSC clinical trial
4. Plans to expand clinical pipeline in other neurodevelopmental epilepsies
5. Presentations from Marinus leadership and key opinion leaders
The TrustTSC trial topline data is expected in Q4 2024. The event will be accessible via live video webcast for virtual participants.
Marinus Pharmaceuticals (Nasdaq: MRNS), a company focused on developing therapeutics for seizure disorders, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will engage in a fireside chat on Thursday, September 19, 2024, at 10:20 a.m. ET.
Investors and interested parties can access the event through a live webcast link available on the Investors and Media page of Marinus' website. For those unable to attend live, a replay of the webcast will be made available approximately two hours after the event concludes and will remain accessible for up to 90 days.
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.
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