Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 5:03 AM ET
✓ APPROVED
Casgevy (exagamglogene autotemcel) was approved by the FDA for sickle cell disease (recurrent vaso-occlusive crises) or transfusion-dependent beta thalassemia, ages 2 and older; the approval was announced on July 1, 2026.
FDA approved expanded use of Casgevy 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)
Daily close, T-120 (1/7/26) through T+5. Run-up high $499.65 on 6/29/26, low $423.24 on 4/29/26 (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
CompanyVertex Pharmaceuticals
Market-cap tierLarge
120-day run-up (T-120→T-1)+2.6%
Cohort decision-day move (history)1.0% median (n=895)
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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Casgevy (exagamglogene autotemcel) approved by the FDA?
Yes. The approval of the application for Casgevy (exagamglogene autotemcel) was announced on July 1, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Which company is behind Casgevy (exagamglogene autotemcel)?
Casgevy (exagamglogene autotemcel) is a Vertex Pharmaceuticals (VRTX) program. The company announced the FDA decision on July 1, 2026; the FDA's own record of the decision is linked on this page.
How did VRTX stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), VRTX moved +2.6%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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