Marinus Pharmaceuticals(US:MRNS)2024-08-13 18:18ZTALMY® Commercial Performance and Growth - ZTALMY® achieved net product revenue of $8.0 million for Q2 2024, representing an 87% growth from Q2 2023[17] - The company anticipates full-year 2024 net product revenue to be between $33 million and $35 million[17] - Marinus achieved profitability on the ZTALMY® commercial investment in Q1 2024, ahead of the original target[17] - The company identifies over 1,000 CDD patients through third-party data sources, presenting a growth opportunity[17] Clinical Trial Updates and Milestones - Topline data from the Phase 3 TrustTSC trial for Tuberous Sclerosis Complex (TSC) is expected in the first half of Q4 2024[6, 20] - Marinus plans to submit a U S sNDA for TSC in April 2025, requesting priority review[38] - The Phase 3 RAISE trial in Refractory Status Epilepticus (RSE) showed that 13% of patients in the IV Ganaxolone arm experienced SE cessation within 30 minutes, compared to 0% in the placebo arm (p<0.0001)[60] - In the RAISE trial, 63% of patients in the IV Ganaxolone arm showed no progression to IV anesthesia for 36 hours, compared to 51% in the placebo arm (p=0 1619)[60] Ganaxolone Development Pipeline - Ganaxolone is designed to modulate both synaptic and extrasynaptic GABAA receptors to calm over-excited neurons[9] - Marinus is developing a second-generation ganaxolone prodrug, with an IND submission targeted for Q4 2025[47] - Patients taking ganaxolone experienced a 30 7% median reduction in monthly major motor seizure frequency, compared to 6 9% for placebo (p=0 0036) in the Marigold trial[14]