Shares of Milestone Pharmaceuticals Inc. gained 25.4% in premarket trading on Monday after the company said its experimental treatment for paroxysmal supraventricular tachycardia met the primary endpoint in a Phase 3 study. Paroxysmal supraventricular tachycardia is a type of arrhythmia. The treatment, etripamil, is a nasal spray. Milestone said it plans to submit a new drug application for etripamil to the Food and Drug Administration in mid-2023. The company’s stock is up 29.6% this year, while the broader S&P 500 has declined 24.8%.
As previously communicated, the Company believes results from the RAPID trial together with the data from the already completed NODE-301 trial could fulfill the efficacy requirement for a New Drug Application (NDA) submission for etripamil in patients with PSVT. The Company continues to enroll patients in the open label NODE-303 safety trial and plans to submit an NDA application in mid-2023 pending agency feedba
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