# MYQORZO (aficamten) PDUFA Event: Obstructive hypertrophic cardiomyopathy

Canonical URL: https://biopharmsignal.com/pdufa-calendar/CYTK/myqorzo-aficamten-maple-hcm-label-update

Ticker: CYTK

Company: Cytokinetics

Event date: 2026-11-14

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sNDA

FDA decision expected. FDA assigned a November 14, 2026 PDUFA date to the MAPLE-HCM supplemental application.

## Event Timeline

### November 14, 2026 — FDA decision expected

FDA assigned a November 14, 2026 PDUFA date to the MAPLE-HCM supplemental application.

[Cytokinetics — sNDA acceptance and PDUFA date](https://ir.cytokinetics.com/press-releases/press-release-details/2026/Cytokinetics-Reports-First-Quarter-2026-Financial-Results-and-Provides-Business-Update/default.aspx)

### May 5, 2026 — FDA acceptance of the sNDA was reported

Cytokinetics reported that FDA accepted the supplemental application supported by the Phase 3 MAPLE-HCM study.

[Cytokinetics — MAPLE-HCM sNDA acceptance](https://ir.cytokinetics.com/press-releases/press-release-details/2026/Cytokinetics-Reports-First-Quarter-2026-Financial-Results-and-Provides-Business-Update/default.aspx)

### February 24, 2026 — Cytokinetics reported submitting the sNDA

The company submitted the supplemental application following the initial U.S. approval and launch of MYQORZO for symptomatic obstructive HCM.

[Cytokinetics — Fourth-quarter 2025 results and sNDA submission](https://ir.cytokinetics.com/press-releases/press-release-details/2026/Cytokinetics-Reports-Fourth-Quarter-2025-Financial-Results-and-Provides-Business-Update/default.aspx)

### August 30, 2025 — MAPLE-HCM results were presented and published

Aficamten was superior to metoprolol for change in peak oxygen uptake and five of six secondary endpoints in the Phase 3 active-comparator study.

[Cytokinetics — Primary MAPLE-HCM results](https://ir.cytokinetics.com/press-releases/press-release-details/2025/Cytokinetics-Announces-Primary-Results-from-MAPLE-HCM-Presented-at-the-European-Society-of-Cardiology-Congress-2025-and-Published-in-The-New-England-Journal-Of-Medicine/default.aspx)

### June 20, 2023 — Phase 3 MAPLE-HCM study started

The active-comparator study began evaluating aficamten monotherapy against metoprolol monotherapy in adults with symptomatic obstructive hypertrophic cardiomyopathy.

[ClinicalTrials.gov — MAPLE-HCM study record (NCT05767346)](https://clinicaltrials.gov/study/NCT05767346)

## Related Pages

- CYTK PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/CYTK.md

- CYTK company profile: https://biopharmsignal.com/company/CYTK.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-10-02 — Cytokinetics Announces Four Upcoming Presentations at the HFSA Annual Scientific Meeting 2026: https://biopharmsignal.com/news/CYTK/cytokinetics-announces-four-upcoming-presentations-at-the-hfsa-annual-scientific-a58dfa3b.md

- 2026-09-30 — Cytokinetics Launches ASPEN-HCM: A Real-World Study Evaluating MYQORZO® (aficamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy: https://biopharmsignal.com/news/CYTK/cytokinetics-launches-aspen-hcm-a-real-world-study-evaluating-myqorzo-aficamten--cfa81aa4.md

- 2026-09-17 — Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/CYTK/cytokinetics-announces-inducement-grants-under-nasdaq-listing-rule-5635-c-4-3b441674.md

- 2026-09-14 — Cytokinetics Announces Call for Proposals for Ninth Annual Communications Grant Program: https://biopharmsignal.com/news/CYTK/cytokinetics-announces-call-for-proposals-for-ninth-annual-communications-grant--37a5b75d.md

- 2026-09-02 — Cytokinetics to Participate in September Investor Conferences: https://biopharmsignal.com/news/CYTK/cytokinetics-to-participate-in-september-investor-conferences-ac3ab76c.md