Marinus Pharmaceuticals maintains Buy rating with $10 target

On Tuesday, Truist Securities maintained its Buy rating on shares of Marinus (NASDAQ:MRNS) Pharmaceuticals (NASDAQ:MRNS) with a consistent price target of $10.00. The firm's outlook is based on the progress of the Phase 3 TrustTSC trial for the treatment of tuberous sclerosis complex (TSC), which is anticipated to report top-line results in late October or early November this year.

The analyst at Truist Securities highlighted that the TrustTSC trial has seen a low discontinuation rate of less than 7%, a significant improvement from the 26% rate observed in the Phase 2 study. The fact that the majority of patients have achieved therapeutically relevant doses is seen as a positive indicator, especially considering the last observation carried forward (LOCF) analysis.

Additional details regarding the trial are expected to be shared at the Analyst Event scheduled for September 20, 2024. Management at Marinus Pharmaceuticals is preparing for a potential New Drug Application (NDA) submission by April 2025, with an anticipated product launch in the second half of 2025.

The company reported second-quarter 2024 revenue of $8 million for Ztalmy, which aligns with the estimates of Truist Securities. Furthermore, Marinus management has reiterated its full-year 2024 sales forecast of $33 to $35 million. The analyst believes that the treatment for TSC could be seamlessly integrated into Marinus's existing commercial infrastructure.

In other recent news, Marinus Pharmaceuticals has been making significant strides in the development of treatments for seizure disorders. The company received approval from the China National Medical Products Administration for its ganaxolone oral suspension, a treatment for epileptic seizures in patients with CDKL5 deficiency disorder.

Marinus has also completed enrollment for its global Phase 3 TrustTSC clinical trial, which evaluates the effectiveness of oral ganaxolone in treating seizures associated with tuberous sclerosis complex. Topline data from this trial is anticipated in the first half of Q4 2024.

In addition to these developments, Marinus announced the issuance of a new method of use patent for ganaxolone in the treatment of TSC by the United States Patent and Trademark Office, set to expire in 2040.

However, Marinus reported mixed results from the RAISE trial, a Phase 3 study evaluating intravenous ganaxolone for treating refractory status epilepticus. The trial met its first co-primary endpoint but failed to meet the second.

Despite these mixed outcomes, Marinus continues to see potential in IV ganaxolone. Analysts from H.C. Wainwright & Co and JMP Securities maintain a positive outlook for Marinus, holding a buy rating and a market outperform rating respectively.

InvestingPro Insights

As Marinus Pharmaceuticals (NASDAQ:MRNS) gears up for the results of its Phase 3 TrustTSC trial, investors are closely monitoring the company's financial health and stock performance. According to real-time data from InvestingPro, Marinus has a market cap of approximately $65.37 million and has experienced a revenue growth of 30.53% over the last twelve months as of Q1 2024. Despite this growth, the company's gross profit margin stands at a concerning -246.64%, reflecting challenges in profitability.

An InvestingPro Tip indicates that analysts are adjusting their earnings expectations downward for the upcoming period, which could impact investor sentiment. Additionally, the company's stock has been trading near its 52-week low, suggesting that the market may have significant reservations about its near-term prospects. However, it's worth noting that Marinus has sufficient liquid assets to cover its short-term obligations, which may provide some financial stability as it navigates its clinical trials and potential commercial launches.

Investors interested in a deeper dive into Marinus Pharmaceuticals can find additional InvestingPro Tips, including insights on the company's cash burn and valuation, by visiting https://www.investing.com/pro/MRNS. Understanding these aspects is crucial as the company prepares for significant milestones in its clinical and commercial journey.

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