Market reactionShares fell 13% on Nov 5.
Cytokinetics sells MYQORZO (aficamten) for obstructive hypertrophic cardiomyopathy in the U.S., EU, China, UK and Canada and is seeking approval in non-obstructive HCM.
MYQORZO treats obstructive hypertrophic cardiomyopathy and is approved in five markets. It sold $25.3 million in the second quarter, and about 1,500 patients had received it by June 30. FDA decides by November 14, 2026 on adding MAPLE-HCM data, where it beat metoprolol. In non-obstructive HCM, ACACIA-HCM met both primary endpoints, with a filing planned this quarter. Cytokinetics is suing to invalidate a BMS patent and held about $1.7 billion.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: Non-obstructive HCM filing proceeds
Does Cytokinetics file the non-obstructive HCM application on time and does FDA accept it?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
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MYQORZO is approved in five markets; FDA rules on its MAPLE-HCM label November 14
MYQORZO approved in US, EU, and UK with a second indication filing in; commercial ramp and nHCM sNDA decision determine how far the franchise grows
MYQORZO approved in US, EU, and UK with Phase 3 wins in two HCM subtypes; commercial ramp and BMS patent litigation are the tests
MYQORZO approved and generating revenue across US, EU, and China; label expansion to non-obstructive HCM hinges on Nov 2026 FDA decision
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Drug pages: Aficamten
Disease areas: Neuromuscular diseases, Obesity, diabetes and heart disease
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
4 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.