Full ACACIA-HCM safety signals at ESC prompt CYTK drop
Full ACACIA-HCM safety signals at ESC prompt CYTK 7.18% drop
- Hot Line presentation of Phase 3 ACACIA-HCM full results occurred today at ESC Congress in Munich.
- Topline efficacy met endpoints but deltas were modest (KCCQ +3 pts, pVO2 improvement).
- Safety data showed LVEF <50% in 10% of aficamten patients vs 1% placebo, plus dose interruptions.
- Rare serious heart failure events noted, raising approvability and commercial uptake concerns for nHCM.
- High valuation and competition (e.g. Edgewise better tolerability data) amplified selling pressure.
- Builds on prior positive topline from May but details failed to excite investors per market reaction.
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