NDA for CARDAMYST™ in PSVT under review by FDA; PDUFA March 27, 2025

MONTREAL and CHARLOTTE, N.C., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced its licensing partner, Ji Xing Pharmaceuticals Ltd, released positive topline results from a multi-center, randomized, double-blind, placebo-controlled trial in China evaluating the efficacy and safety of etripamil nasal spray in paroxysmal supraventricular tachycardia (PSVT). The trial design closely matched the RAPID Phase 3 Study of etripamil in PSVT conducted by Milestone in North America and Europe.

MONTREAL and CHARLOTTE, N.C., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Joseph Papa to its Board of Directors (“Board”), effective September 3, 2024.

– NDA for CARDAMYST™ in PSVT accepted by FDA in 2Q 2024; PDUFA in March 2025

MONTREAL and CHARLOTTE, N.C., June 12, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will host Part I of its virtual investor educational series on Thursday, June 20, 2024, at 8:00 AM ET. To register for “Learnings from the Field: Expert Perspectives on Managing PSVT in the Community Setting,” click here.

MONTREAL and CHARLOTTE, N.C., May 31, 2024 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that members of its management team will participate in the Jefferies Global Healthcare Conference being held in New York City, NY from June 4-6, 2024.

MONTREAL and CHARLOTTE, N.C., May 29, 2024 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the United States Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) on May 26, 2024 for CARDAMYST (etripamil) nasal spray, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024.

– NDA for etripamil in PSVT resubmitted in 1Q 2024
– Cash resources as of March 31, 2024 expected to fund operations into 2026
– Dialogue with FDA to finalize Phase 3 protocol for etripamil in AFib-RVR is progressing