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Marinus Pharmaceuticals, Inc - MRNS STOCK NEWS

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.

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Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) announced the publication of two-year open-label extension Marigold trial data of ZTALMY® (ganaxolone) oral suspension CV in patients with CDKL5 deficiency disorder (CDD). The company also revealed the acceptance of seven abstracts for presentation at the upcoming American Epilepsy Society (AES) 2023 Annual Meeting, showcasing the potential of ganaxolone in the treatment of refractory seizure disorders.
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Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) announced that CEO Scott Braunstein, M.D. will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference. The event will be held on November 28 at 12:55 p.m. Eastern Time. A webcast link is available on Marinus’ website, with a replay accessible for 90 days.
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MRNS: Marinus Pharmaceuticals Announces Grant of Inducement Awards to New Employee
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Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) reported Q3 net product revenue of $5.4 million, with 2023 net product revenue guidance increased to between $18.5 and $19 million. Over 75% of patients required for the interim analysis are now enrolled in the Phase 3 RAISE trial in refractory status epilepticus, with topline data anticipated Q2 2024. The company also initiated the Marinus Access Program to expand global availability of ZTALMY, and has a cash runway projected into Q4 2024 with $176.4 million in cash, cash equivalents, and short-term investments as of September 30, 2023.
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Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) has announced the initiation of the Marinus Access Program, a global managed access program for ZTALMY® (ganaxolone) oral suspension CV. This program will enable physicians to request ZTALMY for eligible patients with seizures associated with CDKL5 deficiency disorder (CDD) in geographies where the product is not commercially available and as supported by local regulatory requirements. The U.S. Food and Drug Administration and the European Commission have approved ZTALMY for appropriate patients with CDKL5 deficiency disorder.
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Marinus Pharmaceuticals plans to release financial results for Q3 2023 on November 7, 2023. A conference call will be held at 8:30 a.m. Eastern Time on the same day.
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Marinus Pharmaceuticals grants inducement awards to new employees
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Marinus Pharmaceuticals CEO to participate in fireside chat at Cantor Global Healthcare Conference
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Marinus Pharmaceuticals expects estimated net product revenue of $5-5.2 million for Q3 2023 from ZTALMY. Cash runway extended into Q4 2024 with projected cash of $170-175 million as of September 30, 2023. Enrollment in Phase 3 RAISE trial on track for topline data in Q1 2024. Ganaxolone development in RAISE trial funded in part by BARDA. TSC trial anticipated to enroll 128 patients with topline data expected in mid-2024. Total cash, cash equivalents, and short-term investments projected to be between $170-175 million at the end of Q3 2023.
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Marinus Pharmaceuticals announces speakers for Investor & Analyst Event on September 19. Key opinion leaders will discuss clinical experience treating patients with seizure disorders. In-person attendance open to research analysts and institutional investors.
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FAQ

What is the current stock price of Marinus Pharmaceuticals (MRNS)?

The current stock price of Marinus Pharmaceuticals (MRNS) is $0.3223 as of November 21, 2024.

What is the market cap of Marinus Pharmaceuticals (MRNS)?

The market cap of Marinus Pharmaceuticals (MRNS) is approximately 17.4M.

What is Marinus Pharmaceuticals, Inc.?

Marinus Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapeutics for epilepsy and neuropsychiatric disorders.

What is ganaxolone?

Ganaxolone is an innovative therapeutic being developed by Marinus Pharmaceuticals to treat conditions such as epileptic seizures, postpartum depression, and other neuropsychiatric disorders.

What is CDKL5 disorder?

CDKL5 disorder is a severe, rare genetic condition affecting children, causing difficult-to-control seizures and neuro-developmental impairments.

What does orphan drug designation mean?

Orphan drug designation is granted by the FDA to novel drugs that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S., providing development incentives like tax credits and market exclusivity.

Which other conditions is ganaxolone being developed for?

Ganaxolone is also being developed for drug-resistant focal onset seizures, status epilepticus, Fragile X Syndrome, and PCDH19-related epilepsy.

When did Marinus receive orphan drug designation for ganaxolone?

Marinus received orphan drug designation for ganaxolone on June 29, 2017.

What incentives does orphan drug designation provide?

Orphan drug designation provides various development incentives including tax credits, market exclusivity, and assistance with clinical trial design.

What is the primary area of focus for Marinus Pharmaceuticals?

Marinus Pharmaceuticals primarily focuses on the development and commercialization of neuropsychiatric therapeutics.

Why is ganaxolone significant?

Ganaxolone is significant because it aims to address unmet clinical needs in conditions like epilepsy and postpartum depression, offering new hope for patients.

How does Marinus Pharmaceuticals impact patient care?

Marinus Pharmaceuticals impacts patient care by bringing innovative therapies to market, particularly for challenging neurological and psychiatric conditions.

Marinus Pharmaceuticals, Inc

Nasdaq:MRNS

MRNS Rankings

MRNS Stock Data

17.38M
49.03M
10.94%
83.04%
10.28%
Biotechnology
Pharmaceutical Preparations
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United States of America
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