Milestone gears up for CARDAMYST launch in 2025

MONTREAL and CHARLOTTE, N.C. - Milestone Pharmaceuticals Inc . (Nasdaq: NASDAQ:MIST), currently valued at $133.8 million, is actively preparing for the potential mid-2025 launch of its lead investigational product, CARDAMYST™ (etripamil) nasal spray, for the treatment of Paroxysmal Supraventricular Tachycardia (PSVT). The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of March 27, 2025, for the New Drug Application (NDA) of CARDAMYST. According to InvestingPro analysis, the company maintains a strong liquidity position with cash reserves exceeding debt levels, though it's currently experiencing rapid cash burn as it approaches this crucial milestone.

The company has not planned an advisory committee with the FDA and is strengthening its commercial capabilities in anticipation of approval. Jeff Moore has been appointed as VP of Sales, and regional sales management is expected to be in place in February. A team of approximately 60 professionals is being assembled to target clinical cardiologists, electrophysiologists, and primary care physicians focused on cardiac care. Hiring for sales representatives will coincide with the anticipated FDA approval. With analyst price targets ranging from $2 to $25, InvestingPro subscribers can access detailed financial analysis and 12 additional ProTips to evaluate the company's growth potential.

Milestone (WA:MMD) will host an investor event on February 25 in New York to provide an overview of its commercial strategy for CARDAMYST. The company's stock has shown strong momentum with a 33.77% return over the past six months, reflecting growing investor interest. Assuming approval, the company will present its first branded product at the American College of Cardiology annual meeting from March 29 to 31, 2025, in Chicago, followed by the Heart Rhythm Society Annual Meeting from April 24 to 27, 2025, in San Diego.

Additionally, Milestone plans to initiate a Phase 3 pivotal trial in the first half of 2025 for etripamil's use in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) in an at-home setting. This follows the successful RAPID trial in PSVT and incorporates FDA feedback into the trial protocol.

Etripamil is designed as a rapid response therapy for patients to self-administer without medical supervision for symptomatic episodic attacks associated with PSVT and AFib-RVR. If approved, it aims to provide a new treatment option for on-demand care and self-management, potentially giving patients more control over their condition.

This information is based on a press release statement from Milestone Pharmaceuticals Inc . and reflects the company's plans and expectations as of this date. Actual results and the timing of events may differ materially from those anticipated in the forward-looking statements due to various risks and uncertainties, including but not limited to FDA interactions and market conditions.

In other recent news, H.C. Wainwright analyst Patrick Trucchio reiterated a Buy rating for Milestone Pharmaceuticals, maintaining a price target of $25.00. This decision comes as the company anticipates approval and launch of CARDAMYST, a novel nasal spray for treating paroxysmal supraventricular tachycardia episodes. Milestone's management team, including President and CEO Joseph Oliveto, expressed optimism for CARDAMYST's approval, with a Prescription Drug User Fee Act date set for March 27.

In addition, the company is set to initiate a Phase 3 program in the first half of 2025 for atrial fibrillation with rapid ventricular rate, potentially expanding its patient base. H.C. Wainwright projects that CARDAMYST could generate revenues exceeding $1 billion, considering its application in both PSVT and AFib-RVR if approved. These recent developments underline the firm's strong Buy recommendation for Milestone Pharmaceuticals.

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