Milestone Pharmaceuticals INC 8-K filings

Milestone Pharmaceuticals announced Q2 2026 results, highlighting a significant increase in insurance coverage for CARDAMYST to over 50% of commercially insured lives and the activation of its Phase 3 trial for atrial fibrillation.

Milestone Pharmaceuticals Inc. held its annual shareholder meeting on June 10, 2026, approving an amendment to its 2019 Equity Incentive Plan to increase authorized shares and re-electing the board of directors.

Milestone Pharmaceuticals reported Q1 2026 results, highlighting early sales traction for CARDAMYST, securing national formulary coverage, and initiating a Phase 3 trial for AFib-RVR, supported by a strong cash position.

Milestone Pharmaceuticals announced its Q4 and full-year 2025 financial results, highlighting the successful commercial launch of CARDAMYST nasal spray for PSVT and a strong cash position.

Milestone Pharmaceuticals announces the U.S. availability of CARDAMYST (etripamil) nasal spray, the first and only FDA-approved self-administered treatment for adults with paroxysmal supraventricular tachycardia (PSVT).

Milestone Pharmaceuticals Inc. announced the closing of its previously disclosed royalty sale agreement, receiving $75.0 million from RTW for U.S. etripamil sales royalties.

Milestone Pharmaceuticals announced the European Medicines Agency accepted its Marketing Authorization Application for etripamil nasal spray for PSVT, with a decision expected by Q1 2027.

Milestone Pharmaceuticals announced FDA approval for CARDAMYST (etripamil) nasal spray, the first self-administered treatment for acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults.

Milestone Pharmaceuticals reported Q3 2025 financial results, highlighted a December 13, 2025 PDUFA date for CARDAMYST, and strengthened its balance sheet for a potential launch.

Milestone Pharmaceuticals reports Q2 2025 results, announces FDA acceptance of CARDAMYST CRL response with a new PDUFA date, and strengthens its balance sheet with a $48.7 million equity raise.

Milestone Pharmaceuticals Inc. has priced a public offering of common shares and warrants, expecting to raise approximately $48.7 million in net proceeds to fund the clinical development and commercial launch of its lead cardiovascular drug, etripamil.

Milestone Pharmaceuticals announced the FDA's acceptance of its response to the Complete Response Letter for CARDAMYST, setting a new PDUFA target action date of December 13, 2025, and extending its $75 million royalty purchase agreement with RTW through December 31, 2025.

Milestone Pharmaceuticals Inc. announced the submission of its response to the U.S. Food and Drug Administration's Complete Response Letter for CARDAMYST (etripamil) nasal spray, a key step towards potential approval for paroxysmal supraventricular tachycardia.

Milestone Pharmaceuticals Inc. announced that its shareholders approved amendments to the 2019 Equity Incentive Plan, elected all director nominees, and ratified the auditor at its annual meeting on June 10, 2025.

Milestone Pharmaceuticals announced its Q1 2025 financial results, alongside an update on regulatory efforts to address issues raised by the FDA regarding its CARDAMYST application.

The FDA issued a Complete Response Letter (CRL) for Milestone Pharmaceuticals' New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray, citing Chemistry, Manufacturing and Controls (CMC) issues but no clinical concerns.

Milestone Pharmaceuticals announces the date for its 2025 annual shareholder meeting and deadlines for shareholder proposals and director nominations.

Milestone Pharmaceuticals has entered into an amended agreement with Jefferies LLC to offer common shares up to an aggregate offering price of $77.8 million.

Milestone Pharmaceuticals announces its Q4 and full-year 2024 financial results while awaiting the FDA's decision on CARDAMYST for PSVT, with a potential launch targeted for mid-2025.

Milestone Pharmaceuticals is gearing up for the potential commercial launch of CARDAMYST (etripamil) nasal spray, pending FDA approval, to address the unmet needs of patients with paroxysmal supraventricular tachycardia (PSVT).

Milestone Pharmaceuticals announced its third quarter 2024 financial results, highlighted by progress towards potential FDA approval of CARDAMYST and the initiation of a Phase 3 trial for AFib-RVR in the first half of 2025.

Milestone Pharmaceuticals has appointed industry veteran Joseph Papa to its Board of Directors, effective September 3, 2024.

Milestone Pharmaceuticals announced its Q2 2024 financial results, highlighted by the FDA's acceptance of the NDA for CARDAMYST and a cash runway extending into 2026.

Milestone Pharmaceuticals has appointed two new independent directors, Stuart Duty and Andrew Saik, to its board and reached a cooperation agreement with Alta Fundamental Advisers.

Milestone Pharmaceuticals announced that the FDA has accepted its New Drug Application for CARDAMYST (etripamil) nasal spray, with a target PDUFA date set 10 months from the acceptance date.

Milestone Pharmaceuticals resubmitted its New Drug Application for etripamil for PSVT and reported its first quarter 2024 financial results, highlighting a strong cash position and progress in clinical development.

Milestone Pharmaceuticals released new clinical data demonstrating the effectiveness of etripamil in self-managing recurrent paroxysmal supraventricular tachycardia (PSVT) episodes.

Milestone Pharmaceuticals has resubmitted its New Drug Application to the FDA for etripamil nasal spray, a treatment for paroxysmal supraventricular tachycardia.

Milestone Pharmaceuticals announced its Q4 and full year 2023 financial results, highlighted by a recent financing extending their cash runway into 2026 and plans to resubmit their NDA for etripamil in early Q2 2024.

Milestone Pharmaceuticals has successfully completed a public offering of common shares and pre-funded warrants, raising approximately $32.4 million to fund the development of etripamil and for general corporate purposes.