Marinus Pharma Says RAISE Trial Did Not Meet The Early Stopping Criteria; Stock Dips In Pre-market

(RTTNews) - Shares of Marinus Pharmaceuticals, Inc. (MRNS) were sinking more than 75 percent in the pre-market activity on the Nasdaq after the company announced Monday that its Phase 3 RAISE Trial evaluating intravenous or IV ganaxolone for the treatment of refractory status epilepticus or RSE did not meet pre-defined stopping criteria at the interim analysis.

The pharma company focused on the development of therapeutics to treat seizure disorders announced that an independent Data Monitoring Committee or DMC has recommended continuing the pivotal Phase 3 RAISE trial evaluating IV ganaxolone for the treatment of refractory status epilepticus (RSE) following an interim analysis.

Marinus said it has decided to complete enrollment in the RAISE trial at aaround 100 patients with topline 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.

Scott Braunstein, Chairman and Chief Executive Officer of Marinus, said, "While we are disappointed that RAISE did not meet the early stopping criteria, we will only be able to determine the trial's outcome once we unblind and analyze the full data set. We will also be evaluating potential cost-saving strategies to provide the strongest capital position as we approach enrollment completion in the global Phase 3 TrustTSC trial in tuberous sclerosis complex."

The company's Ganaxolone development in the RAISE trial is being supported in part by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority or BARDA.

Marinus said it expects to complete enrollment in the Phase 3 TrustTSC trial of ZTALMY (ganaxolone) oral suspension CV with approximately 130 patients in mid-May 2024. The Company expects topline results early in the fourth quarter of 2024 and anticipates filing a supplemental New Drug Application to the U.S. Food and Drug Administration in the first half of 2025 with a request for priority review.

Marinus also continues to develop a second-generation ganaxolone formulation intended to provide improved pharmacodynamic and pharmacokinetic profiles that could improve safety, efficacy and tolerability and enable less frequent dosing.

The company further said it continues the successful U.S. commercial launch of ZTALMY, resulting in preliminary net product revenue of between $7.4 million and $7.6 million for the first quarter of 2024.

Marinus estimates preliminary unaudited cash, cash equivalents, and short-term investments of $113.3 million as of March 31, 2024. The company's cost reduction activities to extend the cash runway beyond the fourth quarter of 2024 are under review and are expected to be implemented in the current quarter.

In pre-market activity on the Nasdaq, Marinus shares were losing around 75.07 percent to trade at $1.88.

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