By Chris Wack


Milestone 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.

Following the previously announced receipt of a Refusal to File letter, Milestone held a Type A Meeting with the FDA, which indicated the timing of adverse events in question had minimal impact on the overall characterization of the etripamil safety profile.

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.

Considering the revised timeline for the NDA submission, Milestone has undertaken certain cash conservation measures to reduce spend through program deferrals and team restructuring and expects its existing cash resources will fund operations into mid-2025, including the expected Prescription Drug User Fee Act date for the NDA resubmission.

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.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

02-26-24 1042ET