TD Cowen downgraded Milestone Pharmaceuticals (MIST) to Hold from Buy and suspended the firm’s price target after Milestone announced the FDA issued a Complete Response Letter regarding its New Drug Application for Cardamyst nasal spray for the conversion of acute episodes of PSVT to sinus rhythm in adults. The CRL is “upending imminent launch plans” and timelines to NDA resubmission remain unclear given new concerns on FDA functionality, says the analyst, who adds that commercialization prospects are “also constrained by limited capital.”
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
- Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on MIST:
- Milestone Pharmaceuticals: Buy Rating Affirmed Despite CARDAMYST Approval Delay, Strong Market Potential and Robust Financial Position
- Milestone CRL affirms integrity of clinical data, says H.C. Wainwright
- Biotech Alert: Searches spiking for these stocks today
- Milestone Pharmaceuticals announces FDA issued CRL for etripamil
- Milestone Pharmaceuticals to present clinical data on etripamil