CRISPR and Vertex complete rolling BLA submission to FDA for exa-cel for SCD and TDT

CRISPR Therapeutics AG

Completed rolling Biologics License Applications for exa-cel for sickle cell disease and transfusion-dependent beta thalassemia.
Requests Priority Review; if granted, FDA review shortened to 8 months vs 12.
Supported by Phase 3 data from CLIMB-111, CLIMB-121, and long-term follow-up CLIMB-131.
EU and UK filings submitted Dec 2022, validated by EMA and MHRA in Jan 2023.
Exa-cel has RMAT, Fast Track, Orphan Drug, and Rare Pediatric Disease designations from FDA.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.