Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg) PDUFA date: FDA decision expected November 14, 2026
The FDA is expected to decide on Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg) from Cytokinetics, Incorporated in Obstructive hypertrophic cardiomyopathy (label update based on MAPLE-HCM) by the PDUFA target action date of November 14, 2026. For Obstructive hypertrophic cardiomyopathy (label update based on MAPLE-HCM). sNDA; adds to an existing approval. Verified against the company announcement on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
Questions about this FDA decision
- When is the PDUFA date for Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg)?
- The FDA's PDUFA target action date for Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg) is November 14, 2026. The FDA can act before that date, and the review can be extended.
- What is Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg) being reviewed for?
- The application under FDA review covers Obstructive hypertrophic cardiomyopathy (label update based on MAPLE-HCM).
- Which company is developing Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg)?
- Cytokinetics, Incorporated (CYTK).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).