Milestone Pharma Q1 net loss $20.8M; CRL issues unresolved; Type A meeting requested

Milestone Pharmaceuticals Inc.

2025-Q1 EPS reported -$0.31

Q1 net loss $20.8M vs $10.4M YoY; no revenue; cash $56.0M down from $69.7M.
FDA CRL for CARDAMYST (etripamil) in PSVT cites nitrosamine impurities and facility GMP issues.
Type A meeting requested with FDA to address CMC concerns; no clinical safety/efficacy issues.
New USPTO method-of-use patent extends etripamil IP protection to July 2042.
Phase 3 AFib-RVR enrollment paused to prioritize CRL resolution; commercial ramp temporarily halted.

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