FDA issues Complete Response Letter for etripamil PSVT NDA; no clinical issues raised

Milestone Pharmaceuticals Inc.

CRL focuses on CMC: additional nitrosamine impurity data and facility inspection required.
No clinical safety or efficacy concerns cited by FDA for CARDAMYST (etripamil) nasal spray.
Company plans to request a Type A meeting with FDA to discuss resubmission path.
Cash, cash equivalents and short-term investments of $69.7M as of Dec 31, 2024.
CEO expresses disappointment but remains committed to the program.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.