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Jun 30, 2023
Milestone Pharmaceuticals Q2 2023 Earnings Report
Reported second quarter 2023 financial results and provided a clinical and corporate update.
Key Takeaways
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.
NDA submission for etripamil in patients with PSVT expected in October 2023.
Data featured during oral session at Heart Rhythm 2023 Annual Meeting support the potential of etripamil in patients with AFib-RVR.
Enrollment complete in Phase 2 ReVeRA study of etripamil in patients with AFib-RVR; topline data expected in fourth quarter of 2023.
The company is laying the groundwork required to successfully launch a treatment for patients to self-treat their paroxysmal supraventricular tachycardia (PSVT).
Milestone Pharmaceuticals
Milestone Pharmaceuticals
Forward Guidance
Milestone Pharmaceuticals anticipates a transformative period in the remainder of 2023, with the NDA submission for etripamil and continued progress in clinical trials.
Positive Outlook
- NDA submission for etripamil is expected in October 2023.
- Phase 2 ReVeRA study of etripamil in patients with AFib-RVR has completed enrollment.
- Topline data from the ReVeRA study is expected in the fourth quarter of 2023.
- Etripamil has the potential to be the first FDA-approved treatment for self-treating PSVT.
- Etripamil is designed to be a rapid-response therapy that is self-administered by the patient.
Challenges Ahead
- The regulatory approval process is lengthy and uncertain.
- There are uncertainties related to the timing of the clinical trials.
- There are risks related to the complexity inherent in cleaning, verifying, and analyzing trial data.
- There is no guarantee that the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications.
- There are risks related to the sufficiency of Milestone's capital resources and its ability to raise additional capital in the current economic climate.