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On Tuesday, H.C. Wainwright reiterated a Buy rating on Milestone Pharmaceuticals (NASDAQ:MIST) with a steady price target of $25.00, representing significant upside from the current stock price of $2.41. The stock has shown strong momentum, gaining over 55% in the past six months. The firm’s positive outlook is based on the anticipated approval of CARDAMYST (etripamil) by the FDA for the treatment of paroxysmal supraventricular tachycardia (PSVT) by March 27, 2025. According to InvestingPro, the stock currently trades near its Fair Value, with analysts maintaining a consensus Buy recommendation. Analysts at the firm believe the drug has the potential to become a first-in-class, self-administered therapy that could transform the management of acute episodic cardiology conditions.
Etripamil’s unique, rapid-acting profile may open up a market exceeding $500 million in PSVT alone, according to H.C. Wainwright. Additionally, the drug is expected to explore a larger market opportunity in atrial fibrillation with rapid ventricular rate (AFib-RVR). InvestingPro data reveals the company’s current market capitalization of $159.7 million, suggesting significant growth potential if these market opportunities materialize. However, investors should note that the company is currently burning through cash, with negative EBITDA of $42 million in the last twelve months. A Phase 3 trial for AFib-RVR is scheduled to start patient enrollment in the second quarter of 2025.
The firm also noted that the streamlined supplemental New Drug Application (sNDA) pathway for AFib-RVR, combined with an established safety database from the PSVT program, should facilitate an expansion of etripamil’s label. This could position Milestone Pharmaceuticals to capitalize on a multi-billion-dollar market opportunity across both indications.
Milestone Pharmaceuticals is expected to receive $75 million in milestone payments upon FDA approval, with a commercial launch aimed for mid-2025. H.C. Wainwright sees these developments as significant drivers for the stock’s value, considering the shares to be currently undervalued given the long-term prospects.
In conclusion, H.C. Wainwright’s analysts have expressed confidence in Milestone Pharmaceuticals’ growth trajectory. They underscore the potential near-term catalysts, such as the U.S. regulatory approval for PSVT, the execution of a successful commercial launch, and the initiation of the pivotal Phase 3 program for AFib-RVR, as key factors that can create robust value for shareholders in the near future. The company maintains a healthy current ratio of 9.1, indicating strong short-term liquidity, though InvestingPro analysis shows it operates with moderate debt levels and is not expected to be profitable this year.
In other recent news, Milestone Pharmaceuticals has secured a Notice of Allowance from the United States Patent and Trademark Office for a new patent related to its investigational product, CARDAMYST™ (etripamil) nasal spray. This patent could extend the company’s intellectual property protection in the U.S. until July 2042, enhancing the commercial potential of CARDAMYST™. The New Drug Application for CARDAMYST™ is under review by the U.S. Food and Drug Administration, with a target action date set for March 27, 2025. Milestone (WA:MMD) is preparing for a potential mid-2025 launch, with commercial capabilities being strengthened in anticipation of FDA approval.
Jeff Moore has been appointed as VP of Sales, and a team is being assembled to focus on cardiac care professionals. Additionally, Milestone plans to initiate a Phase 3 trial for etripamil’s use in atrial fibrillation with rapid ventricular rate in 2025. Analyst Patrick Trucchio from H.C. Wainwright has reiterated a Buy rating and a $25 price target for Milestone, citing confidence in CARDAMYST’s potential approval and launch. Trucchio anticipates CARDAMYST’s market introduction could gain momentum in the second half of 2025, with limited refills expected initially. H.C. Wainwright also estimates potential revenues exceeding $1 billion for CARDAMYST if approved for both PSVT and AFib-RVR applications.
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