Milestone Pharmaceuticals Q3 2024 Earnings Report
Key Takeaways
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.
NDA for CARDAMYSTâ„¢ in PSVT under review by FDA with a PDUFA date of March 27, 2025.
Primary focus is preparing for potential FDA approval of CARDAMYST (etripamil) nasal spray for PSVT management.
Clinician interest is high for the etripamil Phase 3 study in AFib-RVR, planned to commence in the first half of 2025.
Etripamil is a novel calcium channel blocker nasal spray under clinical development for PSVT and AFib-RVR.
Milestone Pharmaceuticals
Milestone Pharmaceuticals
Forward Guidance
Milestone Pharmaceuticals is focused on the potential FDA approval and commercial launch of CARDAMYST for PSVT, while also planning for a Phase 3 study in AFib-RVR.
Positive Outlook
- Potential FDA approval of CARDAMYST for PSVT.
- Commercial launch of etripamil for PSVT.
- Phase 3 study in AFib-RVR commencing in the first half of 2025.
- CARDAMYST has the potential to improve how PSVT is managed.
- CARDAMYST positions Milestone to deliver meaningful value to patients, providers, and payors.
Challenges Ahead
- Uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of clinical trials.
- Risks related to the complexity inherent in cleaning, verifying and analyzing trial data.
- Whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications.
- General economic, political, and market conditions.
- Risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate.