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Marinus Pharmaceuticals (MRNS) investor relations material
Marinus Pharmaceuticals Investor Presentation summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Investor Presentation summary12 Nov, 2024
Product and clinical overview
Ganaxolone is a neuroactive steroid that modulates both synaptic and extrasynaptic GABA receptors, offering a differentiated mechanism of action for epilepsy treatment.
ZTALMY (ganaxolone) is FDA-approved for CDKL5 deficiency disorder (CDD) and has a well-characterized safety profile, addressing a significant unmet need.
In the Phase 3 Marigold trial, ganaxolone reduced major motor seizure frequency by a median of 30.7% versus 6.9% for placebo; sustained reductions of ~50% were observed over two years in the open-label extension.
The most frequent adverse events were somnolence, pyrexia, and upper respiratory tract infection, with safety findings consistent across studies.
Commercial performance and strategy
Net product revenue for ZTALMY reached $8.5M in Q3 2024, a 56% increase from Q3 2023, with full-year revenue expected at $33–34M.
Achieved profitability on ZTALMY commercial investment in Q1 2024, ahead of target, driven by strong patient enrollments and prescriber growth.
Commercial strategy includes focused education for healthcare providers, enhanced patient support, and increased investment in patient identification.
Global access is expanding through partnerships in Europe (Orion), China (Tenacia), MENA (Biologix), and a distribution agreement with Uniphar Group.
Clinical pipeline and trial results
In the Phase 3 TrustTSC trial for TSC-associated seizures, ganaxolone showed a 19.7% reduction in seizure frequency versus 10.2% for placebo; the primary endpoint was not statistically significant (p=0.0904).
The RAISE Phase 3 trial in refractory status epilepticus (SE) showed IV ganaxolone led to SE cessation within 30 minutes in 80% of patients versus 13% for placebo (p<0.0001), with similar rates of serious adverse events.
Median time to SE cessation was 4.2 minutes for IV ganaxolone versus 307.2 minutes for placebo; EEG seizure burden reduction was 93% for ganaxolone versus 36% for placebo (p=0.003).
What is the status of the ganaxolone prodrug program?
What are the terms of the Orion collaboration?
What is driving ZTALMY brand growth?
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Marinus Pharmaceuticals, Inc., a clinical stage pharmaceutical company, focuses on developing and commercializing therapeutics to treat epilepsy with a focus on rare and orphan seizures, as well as neuropsychiatric disorders in the United States.
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