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Milestone Pharmaceuticals reports CARDAMYST launch progress and outlines AFib trial timeline

At the Wells Fargo Healthcare Conference, Milestone said its atrial‑fibrillation drug CARDAMYST has gained payer coverage and expects Phase III data in 2028, while its stock trades around $1 after a 41% YTD decline.

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Helena Vásquez · Business Desk · 14 Sept 2026 · 10:38 · 2 min read
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Milestone Pharmaceuticals reports CARDAMYST launch progress and outlines AFib trial timeline

Milestone Pharmaceuticals (MIST) updated investors at the Wells Fargo 21st Annual Healthcare Conference on Tuesday, September 8, 2026, on the commercial rollout of its atrial‑fibrillation therapy CARDAMYST (etripamil). The drug, launched in mid‑February 2024, now enjoys coverage from more than half of commercially insured lives, up from roughly 25% earlier in the year. Express Scripts, covering about 25% of commercial lives, and UnitedHealthcare, which announced coverage in August, are among the major formulary partners.

The company said Medicare coverage decisions are expected in the fourth quarter of 2024, with implementation beginning in 2025. Revenue per prescription is projected to rise to a steady‑state range of $500‑$1,000, and Milestone anticipates a compounding effect from 2026 prescriptions that could lift sales further in 2027.

Milestone’s CEO, Joe, cautioned that prescription volume alone does not fully gauge market success, emphasizing the need for guideline adoption and physician influence. Head of Commercial Lorenz described the patient‑marketing approach as “adding gasoline to a fire,” noting that Milestone relies on digital, streaming and social media channels rather than traditional TV advertising that can exceed $50 million annually.

Financially, Milestone’s shares were trading at $1.14, down 41% year‑to‑date, with a 52‑week high of $3.06 and a market capitalization of $161 million. InvestingPro’s fair‑value estimate stands at $1.12, while analyst price targets range from $2 to $8. The company reported $2.34 million in revenue for the last twelve months and a gross profit margin of 98%.

Looking ahead, Milestone plans a Phase III AFib trial enrolling 400‑500 patients over roughly two years, targeting 150 primary events. Phase II data showed a 35‑beat‑per‑minute heart‑rate reduction versus 5 bpm for placebo. The target market comprises an estimated 10 million diagnosed AFib patients, of whom 30‑40% experience rapid ventricular‑rate episodes, representing a potential 3‑4 million‑patient opportunity.

Milestone employs about 150 staff, with its U.S. headquarters in Charlotte, North Carolina, and roots in Canada. The company expects the trial’s results in the second half of 2028, and its patent protection runs through 2042, subject to regulatory extensions.

This article was produced with AI assistance and edited by a Finance Review Daily journalist.
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Written by
Helena Vásquez
Business Desk

Helena covers corporate news for listed and private companies across Europe, from strategy shifts to leadership changes, with an eye for what a story signals about the broader market.

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Milestone Pharmaceuticals outlines CARDAMYST launch gains and AFib tri · Finance Review Daily