Milestone Pharmaceuticals Announces Plan to Resubmit NDA for Etripamil for the Treatment of PSVT
Milestone Pharmaceuticals Inc. - Common Shares (MIST)
Last milestone pharmaceuticals inc. - common shares earnings: 3/6 07:00 am
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Source: GlobeNewswire
Resubmission of NDA expected 2Q2024 Operating Runway Extended Into Mid-2025 with Cash Conservation Measures MONTREAL and CHARLOTTE, N.C., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced plans to resubmit the New Drug Application (NDA) for etripamil to the U.S. Food and Drug Administration (FDA) for paroxysmal supraventricular tachycardia (PSVT). Following the previously announced receipt of a Refusal to File letter, Milestone held a Type A Meeting with FDA. FDA indicated that the timing of adverse events (AEs) in question had minimal impact on the overall characterization of the etripamil safety profile. To align with FDA’s guidance, the Company will restructure the data sets that capture timing of reported AEs, reformat certain data files to facilitate 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 Refusal to File letter
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- 5/13/24 - Beat
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Sec Filings
- 5/13/24 - Form 8-K
- 5/13/24 - Form 10-Q
- 4/29/24 - Form 10-K/A
- MIST's page on the SEC website