Cytokinetics Inc CYTK
Cytokinetics Inc (Nasdaq: CYTK) is a cardio-renal-metabolic drug developer. Its lead program, MYQORZO (aficamten), is in Phase 3 for symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Its next catalyst on record is aficamten: Company plans to submit a supplemental NDA to FDA for aficamten in symptomatic nHCM in Q4 2026. (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: aficamten — Company plans to submit a supplemental NDA to FDA for aficamten in symptomatic nHCM in Q4 2026. (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| MYQORZO (aficamten) | symptomatic oHCM | small molecule | Approved |
| aficamten | non-obstructive HCM (ACACIA-HCM, Phase 3 met dual primary endpoints) | small molecule | Phase 3 |
| aficamten (CEDAR-HCM) | pediatric oHCM | small molecule | Phase 3 |
| omecamtiv mecarbil | heart failure with severely reduced ejection fraction (COMET-HF, Phase 3 enrolling; prior CRL) | small molecule | Phase 3 |
| ulacamten (CK-586) | heart failure with preserved ejection fraction (AMBER-HFpEF) | small molecule | Phase 2 |
| CK-089 | muscular dystrophy / impaired skeletal muscle function | small molecule | Phase 1 |
Recent results and decisions
- Aug 6, 2026completed enrollment Recently completed patient enrollment in the adolescent cohort of CEDAR-HCM.
Recently completed patient enrollment in the adolescent cohort of CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic obstructive HCM.
Filing - Aug 6, 2026submitted NDAs for aficamten submitted in Hong Kong and Taiwan (Taiwan FDA granted priority review); MYQORZO approved in the UK; reviews ongoing in Canada and Switzerland (ex-US regulators).
Submitted New Drug Applications (NDA) for aficamten in Hong Kong and Taiwan under our collaboration with Sanofi.
Filing - May 5, 2026met Phase 3 ACACIA-HCM met both dual primary endpoints (KCCQ-CSS and peak VO2 at Week 36) with statistically significant improvement vs placebo; key secondaries also significant; no numbers given in this release.
ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 in both Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and maximal exercise performance (peak VO2).
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.