UK MHRA grants MYQORZO (aficamten) marketing authorisation for oHCM
UK regulators approved Cytokinetics’ aficamten (MYQORZO) for obstructive hypertrophic cardiomyopathy on Jul 30, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Cytokinetics, Incorporated CYTK
- 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
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.
More details
- 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
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.
More details
- 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
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.
More details
- 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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- Checked by a person when it was added
- Verify it
- 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