Mitapivat (PYRUKYND)

Note: Agios IR release dated 2026-07-07, subhead 'FDA's PDUFA goal date is November 1, 2026': the FDA accepted the sNDA for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease with Priority Review; the sNDA was submitted under the FDA's accelerated approval pathway and is supported by the global Phase 2/3 RISE UP program in patients aged 16+. Independently corroborated in Agios' 10-Q filed 2026-07-30 (https://www.sec.gov/Archives/edgar/data/1439222/000143922226000118/agio-20260630.htm): 'We submitted a supplemental New Drug Application, or sNDA, for the U.S. accelerated approval of mitapivat in sickle cell disease, or SCD, in May 2026, which was accepted with priority review by the FDA and granted a Prescription Drug User Fee Act, or PDUFA, goal date of November 1, 2026.' Phase 3 REIGNITE is the confirmatory trial. If approved, first oral PK activator in SCD. RESOLVES the pdufa-calendar.json parse-error row 'AGIOS PHARMACEUTICALS ... drugName: null, November 1, 2026'. No AdCom mentioned.