BMY

Camzyos (mavacamten)

FDA PDUFA Target Action Date · Bristol Myers Squibb

Wednesday, September 30, 2026

10 days away

Note: Label-expansion sNDA seeking use in adolescents 12 to <18 with symptomatic oHCM (Phase 3 SCOUT-HCM, met primary endpoint on Valsalva LVOT gradient). FDA granted Priority Review (announced Jun 1, 2026); PDUFA Sept 30, 2026. Cardiac myosin inhibitor already approved for adults with NYHA class II-III oHCM.

Drug Information

Drug Name: Camzyos (mavacamten) (CT.gov)
Application Type: sNDA
FDA Designations: Priority Review
Indication: Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adolescents (12 to <18 years)

Filing Details

Company: Bristol Myers Squibb →
Stock Ticker: BMY
SEC CIK
Source: company press release →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

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Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue