PDUFA date for aficamten sNDA (MAPLE-HCM, monotherapy vs metoprolol) in oHCM
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.
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 (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
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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- Checked by a person when it was added
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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
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.
- Checked
- 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