Cytokinetics, IncorporatedNASDAQ: CYTK

Cytokinetics Announces Additional Data from ACACIA-HCM Presented at the HFSA Annual Scientific Meeting 2026

· Issued by Cytokinetics, Incorporated via GlobeNewswire

Summary by 6ix AI

Cytokinetics, Incorporated said on October 12, 2026 that additional data from its ACACIA-HCM trial of aficamten in adults with non-obstructive hypertrophic cardiomyopathy (HCM, a heart muscle condition) were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, AZ.

Key details

  • ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM) compares aficamten to placebo (a dummy treatment). The additional analyses cover exercise performance, treatment effect, dose titration and safety.
  • A prespecified analysis of overall exercise performance was presented in a late-breaking clinical trial session. It used the 2026 Boston Exercise Aggregate Physiologic Response Score (BEAP-RS), which combines results from five areas, from submaximal exercise through to recovery, into one score.
  • Cytokinetics says that at 36 weeks, treatment with aficamten significantly improved BEAP-RS compared to placebo.
  • Stephen Heitner, M.D., Cytokinetics' Chief Medical Officer, said the company plans to submit a supplemental New Drug Application (a request to expand a drug's approved use) to the US Food and Drug Administration (FDA) this quarter.

What’s still pending

  • Cytokinetics plans to submit the supplemental New Drug Application to the FDA this quarter.

6ix AI wrote this summary from the release below and checked it against the release.

Additional Analyses from ACACIA-HCM Further Characterize Exercise Performance, Treatment Effect, Dose Titration and Safety of Aficamten in Non-Obstructive HCM

SOUTH SAN FRANCISCO, Calif., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM) were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, AZ.

“These additional analyses from ACACIA-HCM add to the body of evidence supporting the overall benefit-risk profile of aficamten in patients with nHCM,” said Stephen Heitner, M.D., Cytokinetics’ Chief Medical Officer. “The current CPET analysis demonstrates significant improvement in a clinically relevant and novel metric of global exercise performance, while additional data provide insights into dose titration and reinforce our confidence in the safety and treatment effect of aficamten in nHCM. We plan to submit a supplemental New Drug Application to the FDA this quarter.”

ACACIA-HCM: Effect of Aficamten on Comprehensive Exercise Performance

Data from a prespecified analysis of comprehensive exercise performance from ACACIA-HCM were presented in a Late Breaking Clinical Trial Presentation. This analysis examined the effect of aficamten on multiple exercise parameters using the novel 2026 Boston Exercise Aggregate Physiologic Response Score (BEAP-RS). The score captures outputs from five individual domains, ranging from submaximal exercise through to recovery, and generates a composite of global exercise performance. At 36 weeks, treatment with aficamten significantly improved BEAP-RS compared to placebo (p

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