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CRSP FDA decision: Jul 1, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

FDA approved expanded use of Casgevy, co-developed by CRISPR Therapeutics and Vertex, for patients ages 2 and older with sickle cell disease with recurrent vaso-occlusive crises, or transfusion-dependent beta thalassemia, the first gene therapy approved for sickle cell disease patients this young (previously approved only for ages 12+).

Run-up into the decision (T-120 → T+5)

PDUFA 7/1/26$61.74$44.341/7/26
Daily close, T-120 (1/7/26) through T+5. Run-up high $61.74 on 2/26/26, low $44.34 on 3/30/26 (T-120 to T-1). FDA decision 7/1/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-07-01
OutcomeApproved
Drug / candidateCasgevy (exagamglogene autotemcel)
IndicationSickle cell disease (recurrent vaso-occlusive crises) or transfusion-dependent beta thalassemia, ages 2 and older
CompanyCRISPR Therapeutics
Market-cap tierMid
120-day run-up (T-120→T-1)-5.9%
Cohort decision-day move (history)2.2% median (n=233)

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: FDA press announcement

Questions

Was Casgevy (exagamglogene autotemcel) approved by the FDA?

Yes. The FDA approved the application for Casgevy (exagamglogene autotemcel) on July 1, 2026. The primary source is linked on this page.

Which company is behind Casgevy (exagamglogene autotemcel)?

Casgevy (exagamglogene autotemcel) is a CRISPR Therapeutics (CRSP) program. The FDA decision came on July 1, 2026; the company's own announcement is linked on this page.

How did CRSP stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), CRSP moved -5.9%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.