Milestone Pharmaceuticals Inc. (MIST), a commercial-stage biopharmaceutical company, reported fourth-quarter and full-year 2025 results and provided corporate updates for its lead product, CARDAMYST(Etripamil).
Company profile
Milestone Pharma focuses on the development and commercialisation of cardiovascular medicines.
Milestone's lead product is CARDAMYST (Etripamil), a novel calcium channel blocker approved by the FDA for the treatment of paroxysmal supraventricular tachycardia (PSVT).
Etripamil is also being studied as a potential treatment for PSVT in pediatric patients and symptomatic atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults.
Notably,it has a license and collaboration agreement with Corxel Pharmaceuticals to develop and commercialise Etripamil.
Q4 Results
For the fourth quarter of 2025, the firm incurred a wider net loss of $17.4 million, or $0.16 per share, from $12.4 million, or $0.19 per share in the prior year.
For the fourth quarter and full year 2025, the firm recorded revenue of $1.54 million from a milestone payment under the license and collaboration agreement with Corxel Pharmaceuticals upon the successful FDA approval of CARDAMYST for the treatment of PSVT in the U.S.
FY'25 Results
For the full year 2025, Milestone's net loss expanded to $63.1 million, or $0.75 per share, from $41.5 million, or $0.67 per share in the year ago.
Milestone had cash, cash equivalents, and short-term investments of $106 million as of December 31, 2025.Including this, the firm noted a $200 million pro forma cash expecting to support strong launch and operating runway into late 2027.
Pipeline Update
On December 12, 2025, Etripamil received FDA Approval of CARDAMYST as the first and only self-administered nasal spray for adults with PSVT, and in late January 2026, CARDAMYST was made generally available through retail pharmacies in the United States.
Currently, a sales team of 60 sales representatives is primarily focused on promoting CARDAMYST to cardiologists, electrophysiologists, and advanced practice providers.
The marketing authorisation application (MAA) for Etripamil nasal spray in PSVT was accepted by the European Medicines Agency (EMA), and a decision is expected in the first half of 2027. Notably, TACHYMIST is the conditionally approved brand name for Etripamil nasal spray in Europe.
Milestone Pharma has planned a Phase 3 registrational program to evaluate self-administered Etripamil as a potential treatment for control of acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults.
For Etripamil in the treatment of AFib-RVR, the company intends to follow the supplemental New Drug Application (sNDA) regulatory approval pathway and expects to leverage the initial PSVT indication, along with results from the planned single Phase 3 study.
Conclusion
"We are excited to see that our commercial launch of CARDAMYST and the initial engagement with providers, patients and payers is tracking or exceeding our pre-launch expectations," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals.
MIST has traded between $0.62 and $3.06 in the last year. The stock closed Friday's trade at $1.36, down $20.0.
Following the news, MIST is up 4.41% at $1.42 in the overnight market.
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