Marinus Pharma decimated on ganaxolone trial miss

16 April 2024

USA-based rare seizure specialist Marinus Pharmaceuticals (Nasdaq: MRNS) saw its shares crash, falling nearly 83% to $1.36, after it revealed that an independent Data Monitoring Committee (DMC) has recommended continuing the pivotal Phase III RAISE trial evaluating intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE) following an interim analysis, which failed to meet early stopping criteria.

Marinus said it has decided to complete enrollment in the RAISE trial at around100 patients with top-line results expected in the summer of 2024. Those results will be used to determine whether to continue development of IV ganaxolone. Marinus remains blinded to the RAISE trial data.

Ahead of the announcement, analysts from both Jefferies and H C Wainwright were bullishly optimistic that the interim data would show 60%-70% response rates for ganaxolone.

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