Milestone Pharmaceuticals (MIST): A Disruptive Entry into the $2B+ PSVT Market with FDA-Approved CARDAMYST Nasal Spray

Milestone Pharmaceuticals (MIST) has emerged as a pivotal player in the treatment of paroxysmal supraventricular tachycardia (PSVT) following the FDA's December 12, 2025, approval of CARDAMYST™ (etripamil) nasal spray, the first novel therapy for this condition in over three decades according to milestone's press release. This milestone not only addresses a critical unmet need in cardiology but also positions the company to capitalize on a rapidly expanding market. With robust clinical data, a well-defined commercialization strategy, and a pipeline poised for strategic expansion, MIST offers a compelling investment opportunity rooted in market access, scalability, and long-term growth potential.

Market Access: Filling a $2B+ Gap in PSVT Treatment

The PSVT treatment market is projected to grow at a compound annual growth rate (CAGR) of 7.0% from 2025 to 2033, with the global market size estimated at $325.93 billion in 2025 and expected to reach $560.00 billion by 2033 according to market analysis. In North America alone, the market is forecasted to expand from $1.25 billion in 2025 to $2.9 billion by 2031, driven by rising incidence of supraventricular arrhythmias and advancements in diagnostics according to mobility foresights. CARDAMYST's first-in-class status as a rapid-acting, self-administered nasal spray positions it to disrupt traditional treatment paradigms, which often rely on emergency room visits or intravenous therapies.

The product's approval addresses a significant gap: over 2 million Americans suffer from PSVT, yet no FDA-approved treatment existed since the 1990s according to stock titan. By enabling at-home management of acute episodes, CARDAMYST reduces healthcare system burden while improving patient quality of life. Analysts highlight that this innovation could capture a substantial share of the market, particularly as awareness of early diagnosis and treatment grows according to market research.

Commercial Scalability: Strategic Partnerships and Distribution Readiness

Milestone's commercialization strategy is meticulously designed to ensure rapid market penetration. The company plans to launch CARDAMYST in Q1 2026, with distribution through retail pharmacies and a focus on securing insurance coverage to ensure patient access according to investor relations. This approach leverages existing infrastructure, minimizing the need for a large in-house sales force-a cost-efficient model for a niche therapy.

Financially, Milestone is well-positioned to support the launch. As of September 30, 2025, the company secured $82.6 million in cash through an equity offering and an amended Royalty Purchase Agreement, providing ample runway for commercialization and pipeline development according to financial report. Additionally, the approval of CARDAMYST has already spurred a "Buy" rating upgrade from TD Cowen, reflecting investor confidence in the company's execution capabilities according to investing.com.

Pipeline Extension: Leveraging PSVT Success for AFib-RVR Expansion

Beyond PSVT, Milestone is strategically expanding its pipeline into atrial fibrillation with rapid ventricular rate (AFib-RVR), a larger indication with significant unmet need. The company has initiated planning for a Phase 3 trial (ReVeRA-301) in AFib-RVR, building on the success of its Phase 2 trial and the PSVT NDA approval according to investor update. This approach allows Milestone to pursue a supplemental New Drug Application (sNDA) pathway, leveraging existing data to accelerate regulatory approval.

The AFib-RVR market is particularly attractive, as it represents a broader patient population with similar pathophysiology to PSVT. By targeting this indication, Milestone aims to replicate the success of CARDAMYST while diversifying its revenue streams. The ReVeRA-301 study design was recently presented at HRX 2025, underscoring the company's commitment to transparency and scientific rigor according to investor announcement.

Capital Position and Strategic Execution

Milestone's financial prudence and strategic foresight further strengthen its investment case. The company's $82.6 million cash reserve as of Q3 2025 ensures sufficient capital to fund both the PSVT launch and the AFib-RVR trial according to financial results. Moreover, the approval of CARDAMYST has enhanced the company's credibility, enabling access to additional capital through equity offerings or partnerships.

The commercial team's readiness is another critical factor. By aligning with retail pharmacy networks and prioritizing insurance coverage, Milestone is minimizing barriers to adoption. This approach mirrors successful models in niche pharmaceutical markets, where rapid access and affordability drive uptake.

Conclusion: A High-Potential Play in Cardiac Innovation

Milestone Pharmaceuticals' FDA-approved CARDAMYST nasal spray represents a transformative entry into the PSVT market, combining first-in-class innovation with a robust commercial strategy. The product's ability to address a $2B+ market, coupled with a pipeline extension into AFib-RVR, positions MIST as a long-term growth story. With a strong capital position, strategic execution plans, and a focus on unmet medical needs, Milestone is well-equipped to deliver value to shareholders while advancing patient care.