Milestone Pharmaceuticals Inc. (MIST)
NASDAQ: MIST · Real-Time Price · USD
1.060
-0.010 (-0.93%)
Sep 10, 2026, 2:54 PM EDT - Market open

Milestone Pharmaceuticals Earnings Call Transcripts

Fiscal Year 2026

Fiscal Year 2025

  • FDA approval and U.S. launch of CARDAMYST marked a pivotal year, with strong initial prescription activity and a robust $200 million cash position supporting operations into late 2027. Early payer coverage is limited, but commercial and Medicare access are expected to expand in 2026–2027.

  • FDA Announcement

    FDA approved Cardamyst nasal spray for PSVT, offering the first new self-administered treatment in over 30 years. Clinical data show rapid and durable efficacy with a favorable safety profile. Launch plans include mid-Q1 availability, broad provider targeting, and strong payer support.

  • Etripamil (Cardamyst) targets a large SVT market with FDA approval expected by year-end. Launch plans focus on retail access, affordable pricing, and payer engagement, with a staged rollout and strong physician adoption anticipated.

  • CARDAMYST is nearing FDA resubmission for PSVT after addressing CMC issues, with strong clinical data showing rapid conversion and reduced ED visits. Commercial launch preparations are complete, and expansion into AFib with RVR is planned, pending resources.

  • Etripamil (CARDAMYST) is nearing FDA approval for PSVT, with a commercial launch and Phase III AFib trial planned for 2024. Clinical data show rapid, effective, and safe relief, with a strong payer-aligned strategy and long-term exclusivity supporting growth.

  • Investor update

    CARDAMYST is set for a mid-2025 US launch pending FDA approval, with an initial focus on high-value cardiology prescribers and commercial payers. The product targets a significant unmet need in PSVT, offering at-home management and cost offsets, with a rational pricing strategy and robust support infrastructure.

Fiscal Year 2024

  • Study update

    Etripamil, a nasal spray for PSVT, addresses significant unmet needs by offering rapid, self-administered relief for patients dissatisfied with current therapies or reluctant to undergo ablation. Physicians estimate 20–50% of PSVT patients could benefit, with wearables expanding early diagnosis.

Fiscal Year 2023

Fiscal Year 2022