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Milestone Pharmaceuticals (NASDAQ:MIST), currently valued at $114 million, resubmitted its filing for Cardamyst nasal spray for paroxysmal supraventricular tachycardia (PSVT) on Monday, following a complete response letter received earlier this year from the Food and Drug Administration. According to InvestingPro data, the stock has shown strong momentum recently, gaining over 23% in the past year despite high price volatility.
The resubmission addresses two key Chemistry, Manufacturing, and Controls issues identified by the FDA, including additional information on nitrosamine impurities based on updated September 2024 guidance and an inspection requirement at a release testing facility that changed ownership during the review process.
H.C. Wainwright maintained its buy rating and $5.00 price target on Milestone (WA:MMD) stock Tuesday, noting that no efficacy or safety concerns were raised in the FDA’s complete response letter. The resubmission follows a Type A meeting with the regulatory agency.
PSVT, a condition that causes episodes of rapid heartbeat, results in over 150,000 emergency room visits annually in the United States. Cardamyst nasal spray is being developed as a potential treatment option that could help patients manage episodes without requiring emergency care.
The research firm estimates Cardamyst could achieve peak sales exceeding $700 million if approved, based on its potential to reduce emergency room visits for PSVT patients. Analyst consensus tracked by InvestingPro shows mixed sentiment, with price targets ranging from $1 to $5, reflecting the stock’s speculative nature. Subscribers can access 8 additional ProTips and comprehensive financial metrics to better evaluate MIST’s investment potential.
In other recent news, Milestone Pharmaceuticals has submitted a response to the U.S. Food and Drug Administration (FDA) regarding its New Drug Application for CARDAMYST (etripamil) nasal spray. This follows a Complete Response Letter from the FDA highlighting issues related to Chemistry, Manufacturing, and Controls, which require resolution before approval. The company has requested a Type A meeting with the FDA to address these concerns. Analysts at TD Cowen have downgraded Milestone Pharmaceuticals’ stock rating from Buy to Hold, citing uncertainties around regulatory approval and commercial launch timing for etripamil. The analysts also noted the company’s limited capital as a constraint to its market strategy. Milestone Pharmaceuticals reported having $69.7 million in cash and short-term investments as of the end of 2024. Additionally, the company announced its 2025 annual meeting of shareholders is set for June 10, 2025, with a record date for voting eligibility on April 15, 2025. Shareholders have deadlines to submit proposals and director nominations in accordance with SEC rules.
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