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Mar 31, 2024
Milestone Pharmaceuticals Q1 2024 Earnings Report
Reported financial results for the first quarter ended March 31, 2024 and provided a regulatory and corporate update.
Key Takeaways
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.
NDA for etripamil in PSVT was resubmitted in Q1 2024.
Cash resources as of March 31, 2024 are expected to fund operations into 2026.
Dialogue with FDA to finalize Phase 3 protocol for etripamil in AFib-RVR is progressing.
The company anticipates potential FDA approval of CARDAMYST™ (etripamil) nasal spray in the first half of 2025.
Milestone Pharmaceuticals
Milestone Pharmaceuticals
Forward Guidance
Milestone Pharmaceuticals is on track for potential FDA approval of CARDAMYST™ (etripamil) nasal spray in the first half of 2025 and expects current cash position, together with a potential future synthetic royalty payment, provides the needed resources to launch CARDAMYST in the U.S. market for patients suffering from PSVT.
Positive Outlook
- Potential FDA approval of CARDAMYST™ (etripamil) nasal spray in the first half of 2025.
- Current cash position, together with a potential future synthetic royalty payment, provides the needed resources to launch CARDAMYST in the U.S. market for patients suffering from PSVT.
- The company remains focused on working with FDA through the review process.
- The company is preparing for commercialization and launch readiness.
- Etripamil is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight.
Challenges Ahead
- The timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA, including the timing of the FDA’s review of the NDA are uncertain.
- The timing of the receipt of the future synthetic royalty payment is uncertain.
- There are risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process.
- Uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of clinical trials.
- General economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad.