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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, a leader in therapeutics for seizure disorders, announced its participation in several key investor and medical conferences in May and June. Events include the Citi Biotech Virtual Co-Panel on May 18, H.C. Wainwright Global Investment Conference available on demand starting May 24, and the Jefferies Global Healthcare Conference on June 9. Marinus will also attend the EILAT Conference from May 22-25 in Madrid and the Epilepsy Foundation Pipeline Conference on June 6. The company focuses on developing innovative treatments like Ganaxolone for both adults and children.
Marinus Pharmaceuticals (MRNS) announced key updates including the commercial launch of ZTALMY® (ganaxolone) set for July 2022. The Phase 3 RAISE trial in refractory status epilepticus is progressing, with data expected in the second half of 2023. Also, the TrustTSC trial is recruiting patients, with topline data anticipated in Q1 2024. Financially, Q1 2022 revenue reached $14.2 million, up from $1.8 million in Q1 2021, primarily due to a one-time revenue from a European collaboration. The cash position improved to $126.3 million, supporting ongoing clinical development.
Marinus Pharmaceuticals (NASDAQ: MRNS) has granted inducement awards to 15 new employees, consisting of non-qualified stock options for 122,300 shares at an exercise price of
Marinus Pharmaceuticals (NASDAQ: MRNS) has resumed screening and recruitment for its Phase 3 RAISE trial targeting refractory status epilepticus (RSE). This follows a temporary pause due to stability concerns related to aluminum phosphate in the drug solution. The independent Data Monitoring Committee found no safety issues with previously treated patients. Marinus plans to enhance the IV ganaxolone formulation for extended shelf life and is expanding trial sites across the U.S. and Canada. Topline results are anticipated in the second half of 2023.
Marinus Pharmaceuticals (MRNS) announced plans to release its Q1 financial results on May 12, 2022, after market close. A conference call will follow at 4:00 p.m. ET to provide a business update and discuss these results. The company focuses on innovative therapies for seizure disorders, with Ganaxolone as its leading neuroactive steroid GABAA receptor modulator, available in both IV and oral forms for adults and children.
Marinus Pharmaceuticals, Inc. (MRNS) announced the grant of a non-qualified stock option to a new employee, totaling 13,800 shares at an exercise price of
Marinus Pharmaceuticals announced the publication of Phase 3 trial results for ZTALMY in The Lancet Neurology. The trial demonstrated ZTALMY's safety and efficacy in treating seizures associated with CDKL5 deficiency disorder (CDD), achieving a median 30.7% reduction in seizure frequency versus 6.9% for placebo (p=0.0036). ZTALMY is the first FDA-approved treatment for CDD in patients aged 2 and older, with expected availability in July. The treatment showed a safety profile consistent with prior studies, with somnolence being the most common adverse effect.
Marinus Pharmaceuticals has secured
Marinus Pharmaceuticals (MRNS) announced FDA approval of ZTALMY® (ganaxolone) for treating seizures in CDKL5 deficiency disorder, marking it as the first approved therapy for this rare epilepsy. The company received a Rare Pediatric Disease Priority Review Voucher and is eligible for $30 million in funding under the Oaktree Capital credit agreement. They initiated patient screening for the Phase 3 TrustTSC trial and accelerated material resupply for the Phase 3 RAISE trial. Financially, Marinus reported cash of $122.9 million and a net loss of $98.8 million for 2021, with expected operating expenses of $152-$157 million for 2022.
Marinus Pharmaceuticals has received FDA approval for ZTALMY (ganaxolone), the first treatment for seizures linked to CDKL5 deficiency disorder (CDD) in patients aged two and older. This approval is based on successful results from the Marigold trial, where ZTALMY demonstrated a median seizure frequency reduction of 30.7%. Additionally, the FDA awarded Marinus a Rare Pediatric Disease Priority Review Voucher. ZTALMY is expected to be available through specialty pharmacies in July 2022.
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