Milestone Pharmaceuticals Inc. (MIST)
NASDAQ (NGS) NASDAQ (NGS) Primary Summary
Milestone Pharmaceuticals Inc. (MIST) Discusses FDA Approval and Clinical Insights for CARDAMYST Nasal Spray in PSVT Treatment Transcript
Milestone Pharmaceuticals Inc. (MIST) Discusses FDA Approval and Clinical Insights for CARDAMYST Nasal Spray in PSVT Treatment Transcript
Milestone Pharmaceuticals Remains A Buying Opportunity Despite Recent Dilution
Despite the CRL setback and heavy dilution, we remain optimistic on etripamil's long-term market potential and Milestone's investment thesis. The recent $52.5 million equity raise was poorly timed and dilutive, but it ensures Milestone's survival even if approval is delayed. Our updated financial model reflects higher risk, dilution, and a later launch, reducing risk-adjusted fair value but still offering upside.
Watch Milestone Pharmaceuticals For (Likely) Upcoming FDA Approval For Cardamyst
I rate Milestone Pharmaceuticals Inc. a Strong Buy under $2, expecting FDA approval for Cardamyst in early 2026 after addressing recent regulatory setbacks. Cardamyst offers a unique, self-administered treatment for PSVT and AFib-RVR with no direct at-home competitors, strong efficacy, and significant pricing power. Financially, Milestone has sufficient runway into 2026, with a $75M milestone payment pending approval, though another small equity raise may be needed if they experience further delays.
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Milestone Pharmaceuticals Inc. Profile
| Biotechnology Industry | Healthcare Sector | Joseph G. Oliveto CEO | NASDAQ (NGS) Exchange | 59935V107 CUSIP |
| CA Country | 33 Employees | - Last Dividend | - Last Split | 9 May 2019 IPO Date |
Overview
Milestone Pharmaceuticals Inc. is a biopharmaceutical company that concentrates its efforts on the innovation and commercialization of cardiovascular medicines. Established in 2003 and based in Montréal, Canada, the company is engaged in addressing unmet medical needs in cardiovascular diseases with a strong focus on developing novel therapeutic solutions. Milestone Pharmaceuticals has forged partnerships through its license and collaboration agreement with Ji Xing Pharmaceuticals for the development and commercialization of its lead product candidate etripamil across various applications, alongside collaborative efforts with the Montreal Heart Institute, the WCN network, and other leading research centers.
Products and Services
Milestone Pharmaceuticals Inc. is primarily focused on the development of its flagship product candidate, etripamil, alongside its engagement in various collaborative research efforts:
- Etripamil: A potent novel calcium channel blocker currently undergoing extensive clinical trials for the treatment of cardiovascular conditions. The applications of etripamil include:
- Phase III clinical trial for the treatment of paroxysmal supraventricular tachycardia (PSVT) in the United States and Canada, focusing on addressing this acute and disruptive heart condition effectively.
- Phase II clinical trial for the treatment of atrial fibrillation and rapid ventricular rate (AF and RVR), representing a concerted effort to expand its application in managing other critical cardiac arrhythmias.
- Collaborations: Milestone Pharmaceuticals has entered into various strategic partnerships to bolster the development and commercialization potential for etripamil across different therapeutic and prophylactic uses:
- License and collaboration agreement with Ji Xing Pharmaceuticals, aimed at exploring and advancing etripamil's prophylactic and therapeutic applications for human use.
- Research partnerships with the Montreal Heart Institute, the WCN network, and additional research centers, facilitating a broad base of clinical support and validation for etripamil's efficacy and safety in treating cardiovascular diseases.
