CYTK · Company research

Cytokinetics, Incorporated

3 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

MilestoneCYTKCytokineticsH2 2026

AMBER-HFpEF Cohort 1 ulacamten enrollment completion, expected in the second half of 2026 (no exact date yet). A company milestone for Cytokinetics (ulacamten for heart failure with preserved ejection fraction): a step in the program rather than a decision or a data readout.

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Entry

AMBER-HFpEF Cohort 1 ulacamten enrollment completion · Company milestone

Drug

ulacamten

For

heart failure with preserved ejection fraction

Stage

Phase 2 · the stage that tests whether the drug actually works

When

H2 2026 · the company gave a window, not a day

Source note

Q2 2026 results PR (Aug 6, 2026): company continues Cohort 1 of AMBER-HFpEF, Phase 2 of ulacamten in symptomatic HFpEF, with enrollment completion expected in H2 2026. COMET-HF (omecamtiv) enrollment continues through 2026.

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Source: manilatimes.net ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

FDA decisionCYTKCytokineticsNov 14, 2026

The FDA is due to decide by Nov 14, 2026 whether to approve Cytokinetics’ aficamten (MYQORZO) for obstructive hypertrophic cardiomyopathy (label expansion based on MAPLE-HCM). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.

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Entry

PDUFA date for aficamten sNDA (MAPLE-HCM, monotherapy vs metoprolol) in oHCM · FDA decision due (PDUFA date)

Drug

aficamten (MYQORZO)

For

obstructive hypertrophic cardiomyopathy (label expansion based on MAPLE-HCM)

Stage

sNDA under FDA review

When

Nov 14, 2026

Source note

FDA accepted the MAPLE-HCM sNDA with a PDUFA target action date of November 14, 2026; could support labeling highlighting superiority over beta-blockers.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneCYTKCytokineticsQ4 2026

sNDA filing for aficamten in non-obstructive HCM, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Cytokinetics (aficamten (MYQORZO) for non-obstructive hypertrophic cardiomyopathy): a step in the program rather than a decision or a data readout.

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Entry

sNDA filing for aficamten in non-obstructive HCM · Company milestone

Drug

aficamten (MYQORZO)

For

non-obstructive hypertrophic cardiomyopathy

Stage

Phase 3 · the last stage before a drug can be approved

When

Q4 2026 · the company gave a window, not a day

Source note

Company guidance: "We expect to file a Supplemental NDA for nHCM in Q4 2026" following positive ACACIA-HCM topline results.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Past catalysts

ConferenceCYTKCytokineticsAug 29, 2026

Cytokinetics presented data on aficamten (MYQORZO) for obstructive hypertrophic cardiomyopathy at a medical meeting on Aug 29, 2026. The linked source has the details.

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Entry

MAPLE-HCM aficamten vs metoprolol late-breaker at ESC 2026 (Aug 29) · Data presented at a medical meeting

Drug

aficamten (MYQORZO)

For

obstructive hypertrophic cardiomyopathy

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 29, 2026

Source note

Aug 20, 2026 PR: Late-Breaking Clinical Science presentation of a MAPLE-HCM analysis by pre-trial treatment, Saturday Aug 29, 2026 at ESC Congress in Munich. A second late-breaker the same session (4:15-4:30 PM CEST) covers ACACIA-HCM effects on cardiac structure and function.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceCYTKCytokineticsAug 28, 2026

Cytokinetics presented data on aficamten (MYQORZO) for non-obstructive hypertrophic cardiomyopathy at a medical meeting on Aug 28, 2026. The linked source has the details.

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Entry

ACACIA-HCM aficamten nHCM primary results Hot Line at ESC 2026 (Aug 28) · Data presented at a medical meeting

Drug

aficamten (MYQORZO)

For

non-obstructive hypertrophic cardiomyopathy

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 28, 2026

Source note

more precise date for existing CYTK|conference|2026-08 ACACIA-HCM ESC item. Cytokinetics' Aug 20, 2026 PR lists the Hot Line 1 presentation of ACACIA-HCM primary results on Friday Aug 28, 2026 in Munich; company also hosts an investor event in Munich on Aug 28 at 2:00 PM CEST.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneCYTKCytokineticsQ3 2026

CAMELLIA-HCM (Japan oHCM) and ACACIA-HCM Japan cohort complete trial conduct, in Q3 2026 (Jul–Sep). A company milestone for Cytokinetics (aficamten for obstructive and non-obstructive HCM (Japan)): a step in the program rather than a decision or a data readout.

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Entry

CAMELLIA-HCM (Japan oHCM) and ACACIA-HCM Japan cohort complete trial conduct · Company milestone

Drug

aficamten

For

obstructive and non-obstructive HCM (Japan)

Stage

Phase 3 · the last stage before a drug can be approved

When

Q3 2026 · the company gave a window, not a day

Source note

Q2 2026 results PR (Aug 6, 2026): Cytokinetics expects to complete trial conduct of CAMELLIA-HCM (Phase 3 in Japanese oHCM patients run by Bayer) and the Japan cohort of ACACIA-HCM in Q3 2026, supporting potential Japan marketing authorization.

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Source: manilatimes.net ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalCYTKCytokineticsJul 30, 2026

UK regulators approved Cytokinetics’ aficamten (MYQORZO) for obstructive hypertrophic cardiomyopathy on Jul 30, 2026. The company can now sell it in that market.

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Entry

UK MHRA grants MYQORZO (aficamten) marketing authorisation for oHCM · Regulatory approval

Drug

aficamten (MYQORZO)

For

obstructive hypertrophic cardiomyopathy

Stage

approved product

When

Jul 30, 2026

Source note

The MHRA authorised aficamten across the UK for symptomatic NYHA class II-III obstructive HCM; NICE concurrently recommended it for use in England and Wales.

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Source: stocktitan.net ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceCYTKCytokineticsMay 11, 2026

Cytokinetics presented data on aficamten (MYQORZO) for obstructive hypertrophic cardiomyopathy at a medical meeting on May 11, 2026. The linked source has the details.

More details

Entry

New SEQUOIA-HCM, MAPLE-HCM and FOREST-HCM analyses shown at ESC-HF 2026 · Data presented at a medical meeting

Drug

aficamten (MYQORZO)

For

obstructive hypertrophic cardiomyopathy

Stage

Phase 3 · the last stage before a drug can be approved

When

May 11, 2026

Source note

Cytokinetics presented nine analyses at the ESC Heart Failure 2026 Congress from the pivotal Phase 3 SEQUOIA-HCM and Phase 3 MAPLE-HCM trials plus the FOREST-HCM open-label extension, including left atrial mechanics, dose-response and 96-week safety.

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Source: ir.cytokinetics.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsCYTKCytokineticsMay 5, 2026

Cytokinetics reported results from its Phase 3 study of aficamten (MYQORZO) for non-obstructive hypertrophic cardiomyopathy on May 5, 2026. The study met its main goal.

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Entry

Phase 3 ACACIA-HCM met both primary endpoints in non-obstructive HCM · Clinical trial results (readout / topline data)

Drug

aficamten (MYQORZO)

For

non-obstructive hypertrophic cardiomyopathy

Stage

Phase 3 · the last stage before a drug can be approved

When

May 5, 2026

Source note

Aficamten hit both dual primary endpoints at Week 36 (KCCQ-CSS and peak VO2) versus placebo in symptomatic non-obstructive HCM, with key secondaries also significant. Cytokinetics guided to a supplemental NDA filing in Q4 2026.

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Source: asecho.org ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsCYTKCytokineticsDec 27, 2023

Cytokinetics reported results from its Phase 3 study of aficamten for Obstructive HCM on Dec 27, 2023. The linked source has what the numbers showed.

More details

Entry

SEQUOIA-HCM topline: aficamten met primary endpoint · Clinical trial results (readout / topline data)

Drug

aficamten

For

Obstructive HCM

Stage

Phase 3 · the last stage before a drug can be approved

When

Dec 27, 2023

Source note

Phase 3 in obstructive hypertrophic cardiomyopathy.

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SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
CYTK headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

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