Milestone Pharmaceuticals Earnings Reports

Milestone Pharmaceuticals is preparing for potential FDA approval of CARDAMYST (etripamil) nasal spray for the management of PSVT and is encouraged by clinician interest in the etripamil Phase 3 study in AFib-RVR.

Milestone Pharmaceuticals' NDA for CARDAMYST™ in PSVT was accepted by the FDA in Q2 2024, with a PDUFA date in March 2025. The company's cash of $83.3 million as of June 30, 2024, is expected to fund operations into 2026. Stuart Duty and Andrew Saik were appointed as independent board directors.

Milestone Pharmaceuticals reported their Q1 2024 financial results and provided a regulatory and corporate update, highlighting the NDA resubmission for etripamil in PSVT and sufficient cash resources to fund operations into 2026.

Milestone Pharmaceuticals reported its Q4 and full year 2023 financial results, highlighting the plan to resubmit the NDA for etripamil in PSVT in early Q2 2024 and the extension of the cash runway into 2026 due to recent financing.

Milestone Pharmaceuticals reported its Q3 2023 financial results, highlighting the submission of the New Drug Application for CARDAMYST and positive results from the Phase 2 study evaluating etripamil for AFib-RVR.

Milestone Pharmaceuticals reported its second quarter financial results, highlighting the expected NDA submission for etripamil in October 2023 and the completion of enrollment in the Phase 2 ReVeRA study.

Milestone Pharmaceuticals is on track for NDA submission for etripamil in Q3 2023. They are expanding market preparation activities and assessing etripamil's potential in AFib-RVR patients, with Phase 2 ReVeRA topline data expected in 2H 2023. Cash resources are expected to fund operations into mid-2025.

Milestone Pharmaceuticals reported their Q4 and full year 2022 financial results. They are on track for a New Drug Application (NDA) submission in the third quarter of this year.

Milestone Pharmaceuticals reported financial results for the third quarter ended September 30, 2022, and provided a clinical and corporate update. The company is keenly focused on preparations for their planned New Drug Application (NDA), which they expect to submit to the U.S. Food and Drug Administration (FDA) in mid-2023 pending agency feedback.

Milestone Pharmaceuticals reported on their Phase 3 PSVT clinical program, highlighting the crossing of the 180th event in the RAPID trial. They are focusing on data cleaning and analysis and anticipate reporting top line data in the middle of the second half of the year. A Phase 3 PSVT study was initiated in China.

Milestone Pharmaceuticals reported a revenue of $15 million due to a license agreement with Ji Xing. The company's operations are focused on developing and commercializing cardiovascular medicines, with its lead product candidate, etripamil, in clinical development. The company had cash and cash equivalents of $114.1 million as of December 31, 2021, and believes this is sufficient to fund planned operations for at least one year.

Milestone Pharmaceuticals reported their third quarter financial results, highlighting the progress of the etripamil PSVT program and the advancement of Phase 3 efficacy and safety studies. They also completed patient research to understand the burden experienced by patients. Data from an analysis of heart rate in patients treated in the NODE-301 trial will be presented at the AHA Scientific Sessions 2021 meeting.

Milestone Pharmaceuticals Inc. reported incurring significant operating losses and negative operating cash flows since its inception. As of December 31, 2020, the company had cash, cash equivalents, and short-term investments of $142.3 million and an accumulated deficit of $163.5 million.