RADNOR, Pa. - Marinus (NASDAQ:MRNS) Pharmaceuticals, Inc. (NASDAQ:MRNS), a company focusing on seizure disorder therapeutics, has announced the issuance of a new U.S. patent for its drug ZTALMY® (ganaxolone), which is used in oral titration regimens for treating various epilepsy disorders. The patent, numbered 12,115,169 and set to expire in September 2042, encompasses treatment for CDKL5 deficiency disorder, tuberous sclerosis complex (TSC), and Lennox-Gastaut syndrome (LGS).
Scott Braunstein, M.D., Chairman and CEO of Marinus, expressed that the new patent enhances the intellectual property protection for ZTALMY and bolsters the company's development and commercial strategies for ganaxolone in conditions with significant unmet medical needs, including TSC and LGS. Braunstein highlighted the decades of research behind the patent and the USPTO's recognition of the distinct nature of the claimed titration regimens. He also emphasized the potential for the revised ganaxolone titration schedule to improve tolerability, compliance, and patient outcomes in a spectrum of epilepsy disorders.
ZTALMY® (ganaxolone) oral suspension CV, introduced in the U.S. market in 2022, is an FDA-approved prescription medication developed by Marinus Pharmaceuticals. The company has been actively growing its intellectual property portfolio as part of its commitment to scientific innovation in the treatment of seizure disorders.
The press release also contained forward-looking statements regarding the expectations of Marinus Pharmaceuticals about the impact of the new intellectual property on the development of additional indications for ZTALMY and its potential benefits for patient outcomes. These statements come with the usual risks and uncertainties faced in clinical development, regulatory processes, and market conditions.
The company's management cautions that the forward-looking statements involve risks that could cause actual results to differ materially from those anticipated. These include the company's ability to protect its intellectual property, regulatory actions, competitive conditions, clinical trial outcomes, and manufacturing issues, among others.
The information for this article is based on a press release statement from Marinus Pharmaceuticals.
In other recent news, Marinus Pharmaceuticals has been making significant strides in its operations. The company's patent related to the use of the drug ganaxolone was recently upheld by the U.S. Patent and Trademark Office Patent Trial and Appeal Board, despite challenges from Ovid Therapeutics (NASDAQ:OVID). This development ensures Marinus Pharmaceuticals' exclusive rights to the use of ganaxolone for treating status epilepticus, a severe form of epilepsy.
Marinus Pharmaceuticals has also reported an increase in net product revenues, amounting to $8 million for the second quarter, primarily due to their flagship product, ZTALMY. The company is planning for the potential launch of ZTALMY for tuberous sclerosis complex (TSC) in the second half of 2025, aiming for profitability within 12 to 18 months post-launch.
The company has been the subject of analyst attention recently, with TD Cowen maintaining its Buy rating on Marinus and Oppenheimer upgrading the stock to Outperform. Both firms have expressed confidence in the trial design and potential efficacy of ganaxolone. Despite a reported net loss before income taxes of $35.8 million for the quarter, Marinus remains on track to meet its revenue guidance for 2024, aiming for net product revenues between $33 million and $35 million. These are some of the recent developments at Marinus Pharmaceuticals.
InvestingPro Insights
Marinus Pharmaceuticals' recent patent issuance for ZTALMY® comes at a crucial time for the company, as reflected in the latest financial data from InvestingPro. Despite the positive news on the intellectual property front, the company faces significant financial challenges.
According to InvestingPro data, Marinus has a market capitalization of $96.4 million, which is relatively small for a biopharmaceutical company with an FDA-approved drug. The company's revenue for the last twelve months as of Q2 2023 stood at $30.26 million, showing a growth of 16.56% over the same period. However, this growth hasn't translated into profitability yet.
InvestingPro Tips highlight that Marinus is "quickly burning through cash" and "suffers from weak gross profit margins." These tips align with the company's financial data, which shows a gross profit margin of -221.93% for the last twelve months as of Q2 2023. This negative margin suggests that the costs associated with producing and selling ZTALMY® currently exceed the revenue it generates.
Despite these challenges, it's worth noting that Marinus has seen strong returns over the last month and three months, with price total returns of 20% and 27.66% respectively. This recent positive trend could be attributed to investor optimism surrounding developments like the new patent issuance.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Marinus Pharmaceuticals, providing a deeper understanding of the company's financial health and market position.
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