MYQORZO (aficamten)

Note: Cytokinetics' 10-Q filed 2026-05-05 states verbatim: 'in January 2026 we submitted, and the FDA subsequently accepted for filing, a supplemental NDA for MYQORZO to the FDA requesting to include the results of MAPLE-HCM, a Phase 3 randomized, double blind, active-comparator clinical trial of aficamten as monotherapy compared to metoprolol as a monotherapy in patients with obstructive HCM, in the label. The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.' STANDARD review - explicitly NOT priority, hence the empty designations array. Same-day 8-K Exhibit 99.1 (https://www.sec.gov/Archives/edgar/data/1061983/000119312526206360/cytk-ex99_1.htm) and the IR version (https://ir.cytokinetics.com/press-releases/press-release-details/2026/Cytokinetics-Reports-First-Quarter-2026-Financial-Results-and-Provides-Business-Update/default.aspx) carry the same sentence. DISAMBIGUATION: aficamten's ORIGINAL oHCM NDA was already approved as MYQORZO in Dec 2025 - this Nov 14, 2026 date is the MAPLE-HCM label-expansion sNDA, a distinct application. Also distinct from ACACIA-HCM (non-obstructive HCM), which is a separate future filing. RESOLVES the pdufa-calendar.json candidate row 'CYTOKINETICS INC / aficamten / November 14, 2026'. Note this date collides with two other Nov 14 entries (Summit ivonescimab, BioXcel IGALMI) - three different companies, not duplicates.