CYTOKINETICS INC 8K

Cytokinetics reported positive Phase 3 ACACIA-HCM results for aficamten in non-obstructive HCM and plans an FDA supplemental NDA filing in Q4 2026 to expand MYQORZO’s indication.

On August 28, 2026, Cytokinetics, Incorporated announced positive primary results from its pivotal Phase 3 ACACIA-HCM trial of aficamten in adults with symptomatic non-obstructive hypertrophic cardiomyopathy, showing statistically significant improvements versus placebo in both dual primary endpoints—Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and maximal exercise performance (pVO2)—as well as several key secondary endpoints, with data presented at the ESC Congress 2026 and published in The New England Journal of Medicine; based on these results, the company plans to submit a supplemental New Drug Application to the FDA in the fourth quarter of 2026 to expand the approved use of MYQORZO (aficamten) beyond obstructive HCM, and it is hosting an investor event and webcast on the same day to discuss these findings and their clinical context.

Filing Facts

CIK

1061983

Ticker

CYTK

Form

8K

Source Type

fda

Accession

0001193125-26-372456

Alert Tier

7