Milestone Pharmaceuticals, Inc. Stock News

FDA Accepted the Company's Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray; New PDUFA Target Date of December 13, 2025

Despite the CRL setback and heavy dilution, we remain optimistic on etripamil's long-term market potential and Milestone's investment thesis. The recent $52.5 million equity raise was poorly timed and dilutive, but it ensures Milestone's survival even if approval is delayed. Our updated financial model reflects higher risk, dilution, and a later launch, reducing risk-adjusted fair value but sti...

MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the pricing of its previously announced underwritten public offering (the “Offering”) of (i) 31,500,000 of its common shares (the “Shares”...

MONTREAL, Quebec and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST) today announced that it has commenced an underwritten public offering (the “Offering”) of its common shares, accompanying Series A warrants to purchase common shares (the “Series A Warrants”) and accompanying Series B warrants to purchase common shares (the “Serie...

New PDUFA Action Date of December 13, 2025 $75 Million Royalty Purchase Agreement Payment from RTW Extended Through 2025 MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) (Milestone) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Milestone's response to issues raised in the Complete Response L...

I rate Milestone Pharmaceuticals Inc. a Strong Buy under $2, expecting FDA approval for Cardamyst in early 2026 after addressing recent regulatory setbacks. Cardamyst offers a unique, self-administered treatment for PSVT and AFib-RVR with no direct at-home competitors, strong efficacy, and significant pricing power. Financially, Milestone has sufficient runway into 2026, with a $75M milestone p...

MONTREAL and CHARLOTTE, N.C., June 16, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced submission of its response to the U.S. Food and Drug Administration (FDA)'s Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of p...

MONTREAL AND CHARLOTTE, N.C., May 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that Amit Hasija, Chief Financial Officer, and Lorenz Muller, Chief Commercial Officer, will present at the Jefferies Healthcare Conference, to take place June 3 - 5, 2025, in New York.