Latest news with #Cardamyst
Yahoo
02-04-2025
- Business
- Yahoo
Milestone Pharmaceuticals downgraded to Hold from Buy at TD Cowen
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.' Discover the latest stocks recommended by top Wall Street analysts, all in one place with Analyst Top Stocks. Make smarter investments with weekly expert stock picks from the Smart Investor Newsletter. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on MIST: Disclaimer & DisclosureReport an Issue 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
Reuters
28-03-2025
- Health
- Reuters
US FDA declines to approve Milestone's heart rhythm nasal spray
March 28 (Reuters) - Milestone Pharmaceuticals (MIST.O), opens new tab said on Friday that the U.S. health regulator had declined to approve its nasal spray to treat a type of heart condition and had called for an inspection of the facility that performs the testing of the drug. Shares of the company more than halved to 95 cents in premarket trading. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The Food and Drug Administration (FDA), in its so-called complete response letter, has also sought additional data on nitrosamine impurities, based on new guidance that was issued after the company had submitted its application for Cardamyst's approval. Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. The FDA highlighted two key chemistry, manufacturing and controls issues related to the spray, called Cardamyst, but did not raise any concerns about its safety or efficacy. The FDA's decision marks another setback for the company after it previously received a "refusal to file" letter, opens new tab from the agency in December 2023, upon which the company resubmitted the marketing application for Cardamyst with changes for substantial review. The agency in its letter said the inspection at a facility that performs release testing for Cardamyst was required to ensure it is in compliance with current good manufacturing practices. The facility changed ownership during the review of the drug, the company said. Milestone said, opens new tab the self-administered nasal spray helped a significantly greater proportion of patients return to normal heart rhythm compared to a placebo in a late-stage study. The spray for the treatment of paroxysmal supraventricular tachycardia (PSVT), which causes abnormal heart rhythm, is characterized by episodes of sudden-onset rapid heartbeats, often exceeding 150 to 200 beats per minute. An estimated two million people in the U.S. are currently diagnosed with PSVT, the company said.
