Progress in Regulatory Milestones
The FDA extended the PDUFA date for aficamten to December 26, 2025. Regulatory reviews in Europe and China are ongoing, with potential approval in China expected in the second half of this year and in Europe by the first half of 2026.
Commercial Readiness for Aficamten
A strong and experienced U.S. sales force has been recruited with over 8,800 applications and nearly all territories filled. The commercial launch in the U.S. is planned for early Q1 2026.
Positive Clinical Trial Results
The MAPLE-HCM trial showed a statistically significant improvement in peak oxygen uptake for aficamten compared to the standard of care beta blocker, metoprolol. The pivotal Phase III trial in nHCM is fully enrolled ahead of schedule.
Financial Stability
The company ended the quarter with approximately $1.04 billion in cash, cash equivalents, and investments. Full-year 2025 financial guidance is being maintained.