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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 (Nasdaq: MRNS) has announced its participation in several upcoming virtual investor conferences in June and July. Key events include the JMP Securities Life Sciences Conference on June 17, the SVB Leerink CNS Forum on June 29, and the Ladenburg Thalmann 2021 Healthcare Conference on July 14. Notable speakers will include Scott Braunstein, M.D., and Joe Hulihan, M.D. Marinus focuses on innovative therapeutics for rare seizure disorders and has made significant advancements in its clinical trials involving ganaxolone, a compound aimed at treating various epilepsy disorders.
Marinus Pharmaceuticals (MRNS) announced a credit financing agreement with Oaktree for up to $125 million, aimed at extending its cash runway for commercial, clinical, and product development. The company reported a net loss of $27.1 million for Q1 2021, compared to $18.7 million the previous year, alongside cash and equivalents of $123.5 million. The firm aims to submit a New Drug Application for ganaxolone for CDKL5 deficiency disorder by mid-2021 and continues its phase 3 trials for refractory status epilepticus (RSE), targeting top-line data in H1 2022.
Marinus Pharmaceuticals (Nasdaq: MRNS) has rescheduled its Fiscal Q1 2021 financial results conference call from May 13 to May 17, 2021, at 8:30 AM ET. This change does not alter the access details for participants. Marinus is focused on developing therapies for rare seizure disorders, primarily through its drug Ganaxolone, which modulates GABAA receptors. The company recently completed a Phase 3 trial for CDKL5 deficiency disorder and has ongoing trials for tuberous sclerosis complex and refractory status epilepticus.
Marinus Pharmaceuticals (Nasdaq: MRNS) will release its Q1 2021 financial results on May 13, 2021, after the market closes. A conference call is scheduled for the same day at 4:30 PM ET to discuss the results and provide a business update. The company is focused on developing innovative therapeutics for rare seizure disorders, including Ganaxolone, which targets GABAA receptors. Marinus recently completed a pivotal Phase 3 trial in children with CDKL5 deficiency and is actively pursuing trials in refractory status epilepticus.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced its leadership team will present at key virtual investor conferences. Presentations will occur at:
- B. Riley Neuroscience Conference on April 29, 9:00 a.m. ET
- 7th Annual Truist Securities Life Sciences Summit on May 4, 11:20 a.m. ET
- Oppenheimer Rare & Orphan Disease Summit available on demand starting May 21, 8:00 a.m. ET
- UBS Global Healthcare Virtual Conference on May 24, 8:00 a.m. ET
All webcasts are accessible via the Marinus website.
Marinus Pharmaceuticals (MRNS) announced the grant of a stock option award to its new CFO, Steven Pfanstiel. The inducement includes 220,000 shares with an exercise price of $13.99 per share, aligning with the last sale price on April 12, 2021. The option will vest 25% after one year, with the remaining shares vesting monthly over three years, contingent on continued employment. Marinus focuses on developing ganaxolone, a treatment for rare seizure disorders, and is conducting several clinical trials, including a Phase 3 trial for refractory status epilepticus.
Marinus Pharmaceuticals (Nasdaq: MRNS) has appointed Steven E. Pfanstiel as Chief Financial Officer and Lisa Lejuwaan as Vice President of Sales. These changes aim to bolster the leadership team and prepare for the potential commercialization of ganaxolone for CDKL5 deficiency disorder (CDD). Pfanstiel brings extensive financial experience from Johnson & Johnson and LifeScan, while Lejuwaan has a strong sales background in rare neurological disorders from Alexion Pharmaceuticals. Both leaders are expected to enhance the company's strategic growth and market presence.
Marinus Pharmaceuticals (Nasdaq: MRNS) announced the grant of non-qualified stock options to 12 new employees, totaling 173,123 shares. The exercise price for 112,875 options is set at $15.91, reflecting the closing stock price on March 18, 2021. The remaining 60,243 options will be priced based on each employee’s start date. Vesting occurs as follows: 25% after one year, and the remaining 75% in monthly installments over three years, contingent on continued employment. This grant aligns with Nasdaq Listing Rule 5635(c)(4), aimed to attract talent crucial for the company’s innovative therapeutics targeting rare seizure disorders.
Marinus Pharmaceuticals, Inc. (MRNS) has appointed Dr. Saraswathy Nochur to its Board of Directors, enhancing its leadership team in the development of therapeutics for rare seizure disorders. Dr. Nochur brings extensive experience in global regulatory strategies, having contributed to multiple drug approvals for rare diseases at Alnylam Pharmaceuticals. Her role will be pivotal as Marinus approaches the FDA submission for ganaxolone to treat CDKL5 deficiency disorder and evaluates ongoing clinical programs. Marinus aims to improve therapeutic options in acute and chronic care for both adult and pediatric populations.
Marinus Pharmaceuticals (MRNS) reported updates on clinical and regulatory activities along with its 2020 financial results. The company ended 2020 with $140 million in cash after raising $70 million in December. They remain focused on submitting a New Drug Application (NDA) for ganaxolone in CDKL5 deficiency disorder and continuing Phase 3 trials for refractory status epilepticus (RSE) and tuberous sclerosis complex (TSC). Net losses for 2020 reached $67.5 million, up from $54.1 million in 2019, driven by increased research and development activities.
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