Cytokinetics Inc CYTK
Cytokinetics Inc (Nasdaq: CYTK) is a cardio-renal-metabolic drug developer. Its lead program, aficamten (MYQORZO), is in Phase 3 for symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). Its next catalyst on record is MYQORZO (aficamten): PDUFA date for sNDA adding MAPLE-HCM results to label (November 14, 2026).
Upcoming catalysts
- November 14, 2026MYQORZO (aficamten) — PDUFA date for sNDA adding MAPLE-HCM results to label
The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.
- November 14, 2026aficamten (MYQORZO) — PDUFA date for sNDA to include MAPLE-HCM results in label
The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.
Next further out: aficamten (MYQORZO) — sNDA submission for symptomatic nHCM (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| aficamten (MYQORZO) | symptomatic obstructive hypertrophic cardiomyopathy (oHCM) | small molecule | Approved |
| aficamten (MYQORZO) | symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) | small molecule | Approved |
| omecamtiv mecarbil | heart failure with severely reduced ejection fraction (HFrEF) | small molecule | Phase 3 |
| ulacamten (CK-586) | heart failure with preserved ejection fraction (HFpEF) | small molecule | Phase 2 |
| CK-089 | muscular dystrophy and conditions of impaired muscle function | small molecule | Phase 1 |
Recent results and decisions
- Nov 4, 2026started Cytokinetics initiated ASPEN-HCM, a real-world study of MYQORZO in symptomatic obstructive HCM.
Recently initiated ASPEN-HCM, a real-world study of MYQORZO in symptomatic oHCM.
Filing - Nov 4, 2026completed enrollment Cytokinetics completed conduct of the main study treatment period of CAMELLIA-HCM, a Phase 3 trial of aficamten in Japanese patients with obstructive HCM.
Completed conduct of the main study treatment period of CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with oHCM.
Filing - Nov 4, 2026approval MYQORZO (aficamten) received authorization from Health Canada for patients with symptomatic obstructive HCM.
MYQORZO received authorization from Health Canada for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) class II-III in adult patients.
Filing
7 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.