Milestone PharmaceuticalsNASDAQ: MIST

NDA for CARDAMYST™ in PSVT under review by FDA; PDUFA March 27, 2025 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 – Cash of $83.3 million as of June 30, 2024 expected to fund operations into 2026 – Stuart Duty and Andrew Saik Appointed as Independent Board Directors MONTREAL and CHARLOTTE, N.C., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the second quarter ended June 30, 2024 and provided a regulatory and corporate update.

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.

Milestone Pharmaceuticals (MIST) has been upgraded to a Zacks Rank #2 (Buy), indicating increasing confidence in the company's earnings outlook. This could lead to a potential rise in the stock price in the short term.

Milestone Pharmaceuticals (MIST) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.

Milestone Pharma (MIST) plunges 31% following an RTF letter from the FDA due to insufficient data to begin a substantive review of the regulatory filing for etripamil nasal spray to treat PSVT.