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Casgevy (exagamglogene autotemcel)

Updated ยทnext FDA decision on the calendar

Casgevy (exagamglogene autotemcel) 2 FDA decisions on record below. Every date links its source.

CRSP catalyst hub · VRTX catalyst hub

About this program

We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Jul 1, 2026 ✓ ApprovedCRSPPDUFA · Jul 1, 2026 ✓ ApprovedVRTX

Questions

When is Casgevy (exagamglogene autotemcel)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Casgevy (exagamglogene autotemcel); 2 FDA decisions are on record below.

What happened at Casgevy (exagamglogene autotemcel)'s most recent FDA decision?

On Jul 1, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.