---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-011476"
form_type: "8-K"
ticker: "CRSP"
cik: "0001674416"
company_name: "CRISPR Therapeutics AG"
filed_at: "2023-04-03T23:59:59+00:00"
generated_at: "2026-06-17T07:04:14.551658+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-23-011476
- form_type: 8-K
- ticker: CRSP
- cik: 0001674416
- company_name: CRISPR Therapeutics AG
- filed_at: 2023-04-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1674416/000095017023011476/0000950170-23-011476-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1674416/000095017023011476/crsp-20230331.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-011476
- JSON: https://secwatch.observer/filing/0000950170-23-011476.json
- Plain text: https://secwatch.observer/filing/0000950170-23-011476.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.