Aficamten is a Cytokinetics Inc program in obstructive hypertrophic cardiomyopathy (MAPLE-HCM sNDA, aficamten vs metoprolol). Its PDUFA date is Nov 14, 2026, the FDA's goal date to complete review of the application. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Obstructive hypertrophic cardiomyopathy (MAPLE-HCM sNDA, aficamten vs metoprolol). Sponsor: Cytokinetics Inc (CYTK). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Avoro Capital Advisors | 4,999,999 | $425.9 million | filed August 14, 2026 |
| RTW Investments | 2,862,003 | $243.8 million | filed August 14, 2026 |
| Baker Bros. Advisors | 211,267 | $18.0 million | filed August 14, 2026 |
| OrbiMed Advisors | 25,800 | $2.2 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Aficamten's PDUFA date is Nov 14, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
No FDA decision for Aficamten is in our archive yet.
In our records Aficamten is under review or in development for Obstructive hypertrophic cardiomyopathy (MAPLE-HCM sNDA, aficamten vs metoprolol).
Cytokinetics Inc (CYTK).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.