RADNOR, Pa. - Marinus (NASDAQ:MRNS) Pharmaceuticals, Inc. (NASDAQ:MRNS) has announced topline results from the RAISE trial, a Phase 3 study evaluating intravenous (IV) ganaxolone for treating refractory status epilepticus (RSE), a severe form of seizure. The trial met its first co-primary endpoint, showing a significant cessation of status epilepticus within 30 minutes of treatment compared to placebo. However, it failed to meet the second co-primary endpoint regarding the progression to IV anesthesia.
The trial involved 96 patients who had not responded to at least two antiseizure medications. While 80% of patients treated with IV ganaxolone saw seizure cessation within the first 30 minutes, only 13% in the placebo group experienced the same. On the other hand, there was no statistical significance in preventing progression to IV anesthesia, with 63% in the ganaxolone group versus 51% in the placebo group not progressing (p=0.162).
The occurrence of serious adverse events was comparable between the ganaxolone and placebo groups, though hypotension was more common with the treatment. The company noted an imbalance in baseline characteristics among participants that may have affected outcomes, such as a higher proportion of patients with more severe conditions in the ganaxolone arm.
Despite the mixed outcomes, Marinus continues to see potential in IV ganaxolone, supported by additional EEG analyses showing durable reductions in seizure burden. The company plans to engage with the FDA to discuss a potential path forward for the treatment.
Marinus also highlighted its commitment to the ZTALMY® franchise and the development of treatments for chronic epilepsies, with Phase 3 TrustTSC topline data expected in the latter part of 2024. Following cost reduction strategies and financing activities, Marinus projects a cash runway extending into the second quarter of 2025.
The information in this article is based on a press release statement from Marinus Pharmaceuticals.
InvestingPro Insights
Marinus Pharmaceuticals (NASDAQ:MRNS) has recently delivered mixed results from its RAISE trial, which has implications for its financial health and stock performance. According to InvestingPro data, the company has a market capitalization of $80.48 million and has experienced a revenue growth of 30.53% over the last twelve months as of Q1 2024. Despite this growth, the company has a negative price-to-earnings (P/E) ratio of -0.57, indicating that it is not currently profitable.
Investors should note that Marinus Pharmaceuticals has been identified as quickly burning through cash, which is a critical factor given its ongoing clinical trials and development projects. Additionally, analysts have revised their earnings downwards for the upcoming period, reflecting concerns about the company's future profitability. With a high price volatility in its stock, Marinus Pharmaceuticals presents a risk profile that requires careful consideration.
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