Why Is Heart Disease-Focused Milestone Pharmaceuticals Stock Plummeting Today?
Portfolio Pulse from Vandana Singh
Milestone Pharmaceuticals Inc (NASDAQ:MIST) stock is plummeting after the FDA issued a Refusal to File letter for the NDA of etripamil nasal spray for PSVT. The FDA's preliminary review found the NDA, submitted in October 2023, incomplete for substantive review, specifically requesting clarification on adverse event data timing in Phase 3 trials. While no concerns about the severity of adverse events were raised, Milestone is planning to meet with the FDA for clarification. MIST shares dropped 32.30% to $1.95.
December 26, 2023 | 2:53 pm
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
Milestone Pharmaceuticals Inc's stock plummeted due to the FDA's RTF letter regarding the NDA for etripamil nasal spray, indicating the application was incomplete. The company is seeking further clarification from the FDA.
The FDA's refusal to file the NDA is a significant regulatory setback for Milestone Pharmaceuticals, directly impacting the company's potential future revenues and growth prospects. The news is likely to shake investor confidence, leading to a negative short-term impact on the stock price, as evidenced by the 32.30% drop.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100