Milestone Pharma Drops Most Since 2020 After FDA Setback (2)

December 26, 2023, 4:35 PM UTC

(Updates stock move starting in headline, adds Jefferies comments starting in second bullet)

Milestone Pharmaceuticals sinks as much as 35%, the most since March 2020, after US regulators refused to begin a substantive review of the company’s proposed drug for an irregular heartbeat condition, seeking clarification about adverse-events data from Phase 3 clinical trials.

  • MIST in a premarket statement Tuesday said it received a Refusal to File (RTF) letter from the Food and Drug Administration related to its application for etripamil to treat paroxysmal supraventricular tachycardia
  • Jefferies (hold) now estimates a potential FDA approval in 2025 plus the associated $75 ...



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