Milestone Pharma Dec 13 PDUFA target for CARDAMYST in PSVT; launch plans set

Milestone Pharmaceuticals (NASDAQ: MIST) reported Q3 2025 results and regulatory updates ahead of a PDUFA target date of December 13, 2025 for CARDAMYST (etripamil) nasal spray in PSVT. The company had $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025, and completed an underwritten equity offering with ~$48.7 million net proceeds plus an amended royalty purchase agreement that includes a $75 million royalty payment upon FDA approval. Clinical data from >600 patients showed consistent efficacy and safety versus placebo. Milestone is preparing for a rapid commercial launch and finalized a Phase 3 protocol in AFib-RVR (ReVeRA-301).

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