Milestone Pharma: FDA accepts CRL response for CARDAMYST; new Dec 13 PDUFA date; Q2 net loss $13M

Milestone Pharmaceuticals Inc.

2025-Q2 EPS reported -$0.51 vs consensus -$0.18 ▼ miss (-181.6%)

FDA accepted CRL response for CARDAMYST (etripamil) for PSVT; new PDUFA target Dec 13, 2025.
Completed public equity offering in July, raising up to $170M gross if warrants exercised; net proceeds ~$48.7M.
Amended royalty agreement with RTW, extending approval deadline to Dec 31, 2025 for up to $75M payment.
Cash, cash equivalents and short-term investments $43.4M as of June 30; net loss $13M for Q2 vs $9.4M Q2 2024.
Commercial expense increased to $5.1M in Q2 (vs $1.8M) as company maintains launch capability pending approval.

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