By Chris WackMilestone Pharmaceuticals shares were up 25% to $2.12 after the company said it plans to resubmit a New Drug Application for etripamil to the U.S. Food and Drug Administration for paroxysmal supraventricular tachycardia. The stock hit its 52-week low of $1.33 on Jan. 22, and is down 28% in the past 12 months. To align with the FDA's guidance, Milestone will restructure the data sets that capture timing of reported adverse events, reformat certain data files to facilitate the FDA's analyses, and resubmit the NDA. Based on the guidance received during the Type A Meeting, the company expects that this approach will address the FDA Refusal to File letter. If FDA approval is granted, Milestone expects to receive a $75 million payment under an existing royalty agreement, which is intended to fund the potential commercial launch of etripamil for paroxysmal supraventricular tachycardia.

Source: Wall Street Journal February 26, 2024 16:24 UTC