Marinus Pharmace Stock Price, News & Analysis

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 $5.17 per share. These options will vest 25% after one year and 75% in monthly installments over the following 36 months, contingent upon continued employment. The grant complies with Nasdaq Listing Rule 5635(c)(4), aimed at attracting talent in the pharmaceutical sector focused on seizure disorder treatments.

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 GABA_A 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 $7.93. This option is aimed to incentivize new hires under Nasdaq Rule 5635(c)(4). The stock options are set to vest 25% on the first anniversary of employment and 75% in equal monthly installments over the subsequent three years. Marinus focuses on developing therapies for seizure disorders, with its lead product, Ganaxolone, targeting a broad patient population.

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 $30 million in additional funding from Oaktree Capital Management due to the FDA's approval of their drug ZTALMY (ganaxolone) for seizures related to CDKL5 deficiency disorder in patients two years and older. This draws the total funding to $75 million. Additionally, the Biomedical Advanced Research and Development Authority (BARDA) extended its performance period for funding through 2023, potentially increasing research funding for the RAISE trial to $51 million.

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.