MIST - Why Milestone Pharmaceuticals (MIST) Stock Is Rising | Benzinga

Milestone Pharmaceuticals Inc (NASDAQ:MIST) shares are trading higher by 19.4% to $2.03 Monday morning after the company announced plans to resubmit the New Drug Application (NDA) for etripamil to the U.S. Food and Drug Administration (FDA) for paroxysmal supraventricular tachycardia (PSVT).

After receiving a Refusal to File letter, the company held a Type A Meeting with the FDA, where it was indicated that the timing of adverse events (AEs) had minimal impact on the overall safety profile of etripamil. The company will restructure data sets and reformat certain files to address FDA concerns and plans to resubmit the NDA in the second quarter of 2024.

The FDA hasn’t requested additional clinical trials before resubmission. Milestone Pharmaceuticals expects its existing cash reserves to fund operations until mid-2025, including the expected Prescription Drug User Fee Act (PDUFA) date for ...

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