09:46 AM EDT, 03/28/2025 (MT Newswires) -- Milestone Pharmaceuticals' ( MIST ) shares fell by more than 60% early Friday after the company said the US Food and Drug Administration highlighted two issues regarding its new drug application for nasal spray etripamil for paroxysmal supraventricular tachycardia.

The company said the FDA's Complete Response Letter did not raise any concerns regarding etripamil's safety or efficacy but cited two chemistry, manufacturing and controls issues to be addressed.

The regulator requested additional information on nitrosamine impurities and said an inspection was required at a facility which changed ownership during the NDA review, Milestone said.

The company said it had $69.7 million in cash, equivalents, and short-term investments as of Dec. 31.

Price: 0.86, Change: -1.39, Percent Change: -61.69