pdufa.bio
HomePDUFA Calendar › AGIO

AGIO PDUFA date: Mitapivat (PYRUKYND) - (RISE UP)

81 business days to decision · 2026-11-01

Agios Pharmaceuticals's Mitapivat (PYRUKYND) - (RISE UP) for Sickle cell disease (sNDA) — FDA decision expected November 1, 2026.

Run-up into the PDUFA

PDUFA 11/1/26today$44.01$26.51
Daily close so far, T-120 through today. High $44.01, low $26.51. Run-up to date +46.9%. Decision 11/1/26. Historical price action, not a forecast.

Key facts

PDUFA date2026-11-01
Business days away81
Drug / candidateMitapivat (PYRUKYND) - (RISE UP)
IndicationSickle cell disease (sNDA)
CompanyAgios Pharmaceuticals
Market-cap tierMid
Cohort decision-day move (history)±2% median

Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction. See the full 2026 PDUFA calendar →