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MONTREAL and CHARLOTTE, N.C. - Milestone Pharmaceuticals Inc . (NASDAQ:MIST), a $146 million market cap company specializing in novel cardiovascular treatments, has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent related to its lead investigational product, etripamil nasal spray, commercially known as CARDAMYST™. The company’s stock has shown strong momentum, gaining over 62% in the past six months. According to InvestingPro, investors have access to 11 additional key insights about MIST’s performance and outlook. This patent pertains to the repeat dose regimen of CARDAMYST™, which demonstrated efficacy in the RAPID Phase 3 study for paroxysmal supraventricular tachycardia (PSVT).
The issuance of this patent could extend Milestone (WA:MMD)’s intellectual property protection in the United States until July 2042, potentially adding six years to the company’s patent portfolio. Joseph Oliveto, President and CEO of Milestone Pharmaceuticals, stated that this added protection is expected to optimize the commercial value of CARDAMYST™. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 15.4, though it’s currently experiencing rapid cash burn as it approaches potential commercialization.
The proposed repeat dose regimen included in the New Drug Application (NDA) for CARDAMYST™ advises patients to administer a second 70 mg dose if symptoms persist ten minutes after the initial dose. The NDA is currently under review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025. The company is preparing for a projected mid-2025 product launch, with the CARDAMYST™ brand name conditionally approved by the FDA.
Etripamil, the active compound in CARDAMYST™, is a novel calcium channel blocker designed as a rapid response, self-administered nasal spray for patients with PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR). This treatment, if approved, aims to provide an on-demand care option for patients, allowing for self-management without immediate medical oversight.
Milestone Pharmaceuticals, with a focus on addressing unmet patient needs in cardiology, continues to develop etripamil, which has completed Phase 3 trials for PSVT and Phase 2 trials for AFib-RVR. Based on InvestingPro analysis, the company maintains an overall "FAIR" financial health score, with analyst price targets ranging from $2 to $25 per share, reflecting the market’s mixed outlook on its commercial prospects. The stock is currently trading above its InvestingPro Fair Value.
The information regarding Milestone Pharmaceuticals’ patent allowance and product development is based on a press release statement.
In other recent news, Milestone Pharmaceuticals is preparing for the potential launch of its investigational product, CARDAMYST, in mid-2025. The U.S. Food and Drug Administration has set a target action date of March 27, 2025, for the approval decision. Milestone is enhancing its commercial capabilities, hiring a sales team, and planning an investor event to discuss its commercial strategy. Concurrently, the company plans to start a Phase 3 trial for etripamil in patients with atrial fibrillation with rapid ventricular rate in the first half of 2025.
H.C. Wainwright analyst Patrick Trucchio maintains a Buy rating with a $25 price target for Milestone Pharmaceuticals, citing optimism about CARDAMYST’s potential approval and launch. The analyst anticipates significant revenue generation, estimating that CARDAMYST could exceed $1 billion in revenues if approved for both PSVT and AFib-RVR. Trucchio notes that the market introduction could gain momentum in the latter half of 2025 and into 2026, with a focus on new patient starts. Milestone’s management has expressed anticipation for the approval, and no advisory committee meeting is expected before the FDA’s decision.
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