Marinus Pharmace Stock Price, News & Analysis

Marinus Pharmaceuticals (MRNS) has received significant regulatory advances for ganaxolone, including the European Medicines Agency's acceptance of its Marketing Authorization Application for CDKL5 deficiency disorder and orphan drug designation for tuberous sclerosis complex. The company aims to commercialize ganaxolone by mid-2022, with patient enrollment in key trials set to begin in early 2022. Financially, Marinus reported a net loss of $19.5 million for Q3 2021, with cash resources of $145.1 million. Guidance for BARDA revenues is now between $6 to $8 million, reflecting a slight decrease from previous estimates.

Marinus Pharmaceuticals (NASDAQ: MRNS) has announced the grant of inducement awards to five new employees, comprising non-qualified stock options to purchase a total of 59,435 shares of common stock. The options have an exercise price of $12.72 per share, aligned with the closing price on November 4, 2021. The vesting schedule allows for 25% of shares to be exercised after one year, with the remaining 75% vesting monthly over three years. This initiative aims to attract talent while adhering to Nasdaq Listing Rule 5635(c)(4).

Marinus Pharmaceuticals (MRNS) is set to release its third-quarter financial results on November 9, 2021, before market opening. The company will hold a conference call at 8:30 a.m. ET to discuss its financial performance and business updates. Marinus focuses on developing therapeutics for rare seizure disorders, particularly Ganaxolone, which acts on GABA_A receptors. The company has made significant progress with trials, including a pivotal Phase 3 trial in CDKL5 deficiency disorder and ongoing studies in other seizure-related conditions.

Marinus Pharmaceuticals (MRNS) has partnered with the Loulou Foundation and six biotech organizations to conduct a three-year observational study, CANDID, focusing on CDKL5 deficiency disorder (CDD). This study aims to explore the natural history of CDD and the effectiveness of various clinical assessments. Marinus is progressing with its investigational drug ganaxolone for CDD, with the FDA giving priority review to its New Drug Application, set for a decision by March 20, 2022. The drug has shown promising results in trials, with significant reductions in seizure frequency.

Marinus Pharmaceuticals announced the grant of inducement stock options to five new employees, totaling 33,998 shares at an exercise price of $11.75 per share, equal to the closing price on October 7, 2021. These options will vest over four years, starting with 25% on the one-year anniversary of employment. This is aimed at attracting talent in accordance with Nasdaq Listing Rule 5635(c)(4). Marinus is focused on developing therapeutics for seizure disorders, with ongoing clinical trials for its lead product, Ganaxolone.

Marinus Pharmaceuticals (MRNS) will present updates on its pipeline and commercial plans in a virtual R&D event today at 9 AM ET. Key highlights include advancing clinical trials for ganaxolone, focusing on CDKL5 deficiency disorder (CDD), tuberous sclerosis complex (TSC), and status epilepticus (SE). The marketing authorization application for CDD is expected to be validated by the EMA by the end of October, with a PDUFA date for the FDA set for March 20, 2022. Additionally, they plan the commercial launch of Ztalmy®, a proposed oral ganaxolone treatment.

Marinus Pharmaceuticals (MRNS) will host a virtual R&D event on October 5, 2021, from 9:00 a.m. to 12:00 p.m. Eastern Time. Key executives will present insights on the company’s clinical development programs, commercial strategies, and pipeline expansions. Topics include updates on the IV ganaxolone program for status epilepticus and plans for a Phase 3 trial in tuberous sclerosis complex. The event is open for investor registration, and a replay will be available on the company website.

Marinus Pharmaceuticals (MRNS) announced that the FDA has accepted its New Drug Application (NDA) for ganaxolone to treat seizures associated with CDKL5 deficiency disorder (CDD). The NDA has been granted a Priority Review designation with a PDUFA action date set for March 20, 2022. With this acceptance, Marinus can access $30 million under its financing agreement with Oaktree Capital Management. The NDA is based on positive data from the Marigold study, which showed a 30.7% reduction in major motor seizure frequency in treated patients.

Marinus Pharmaceuticals (MRNS) has granted inducement awards to five new employees, comprising non-qualified stock options for 14,313 shares at an exercise price of $12.54 per share. This price matches the closing price on September 7, 2021. The stock options will vest 25% on the one-year anniversary of employment, with the remaining shares vesting in 36 monthly installments. Marinus focuses on developing innovative therapeutics for seizure disorders, including ongoing and upcoming Phase 3 trials for various conditions.