Brief: Milestone Pharmaceuticals Announces Plan to Resubmit NDA for Etripamil for the Treatment of PSVT

Milestone Pharmaceuticals

26/02/2024 12:08

Feb 26 (Reuters) - Milestone Pharmaceuticals Inc
 MIST.O :
    * MILESTONE PHARMACEUTICALS ANNOUNCES PLAN TO RESUBMIT NDA
FOR
ETRIPAMIL FOR THE TREATMENT OF PSVT
    * MILESTONE PHARMACEUTICALS INC - RESUBMISSION OF NDA
EXPECTED
2Q2024
    * MILESTONE PHARMACEUTICALS INC - OPERATING RUNWAY EXTENDED
INTO
MID-2025 WITH CASH CONSERVATION MEASURES
    * MILESTONE PHARMACEUTICALS - WILL RESTRUCTURE DATA SETS
THAT
CAPTURE TIMING OF REPORTED AES, REFORMAT CERTAIN DATA FILES TO
FACILITATE FDA'S ANALYSES
    * MILESTONE PHARMACEUTICALS INC - EXPECTS THAT NEW APPROACH
WILL
ADDRESS REFUSAL TO FILE LETTER FROM FDA
    * MILESTONE PHARMACEUTICALS INC - FDA HAS NOT REQUESTED THAT
COMPANY COMPLETE ADDITIONAL CLINICAL EFFICACY OR SAFETY TRIALS
PRIOR TO RESUBMITTING NDA
    * MILESTONE PHARMACEUTICALS INC - UNDERTAKEN CERTAIN CASH
CONSERVATION MEASURES TO REDUCE SPEND THROUGH PROGRAM DEFERRALS
AND TEAM RESTRUCTURING
    * MILESTONE PHARMA-IF APPROVAL GRANTED, SEES TO GET $75
MILLION
UNDER ROYALTY DEAL, INTENDED TO FUND POTENTIAL COMMERCIAL LAUNCH
OF ETRIPAMIL FOR PSVT

Source text for Eikon:  ID:nGNX69tC9Q 
Further company coverage:  MIST.O 

 ((Reuters.Briefs@thomsonreuters.com;))