---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-22-018864"
form_type: "8-K"
ticker: "CRSP"
cik: "0001674416"
company_name: "CRISPR Therapeutics AG"
filed_at: "2022-09-27T23:59:59+00:00"
generated_at: "2026-06-23T07:15:56.007481+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA grants rolling review for CRISPR/Vertex exa-cel; submissions planned Q4 2022 / Q1 2023

## Summary
- FDA granted rolling review for exa-cel BLA for sickle cell disease and transfusion-dependent beta thalassemia.
- BLA submission starts November 2022; completion expected by end of Q1 2023.
- EMA and MHRA submissions on track for submission by end of 2022.
- Exa-cel holds FDA RMAT, Fast Track, Orphan Drug designations; EMA PRIME and Orphan Drug.

## SEC filing metadata
- accession: 0000950170-22-018864
- form_type: 8-K
- ticker: CRSP
- cik: 0001674416
- company_name: CRISPR Therapeutics AG
- filed_at: 2022-09-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1674416/000095017022018864/0000950170-22-018864-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1674416/000095017022018864/crsp-20220927.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-22-018864
- JSON: https://secwatch.observer/filing/0000950170-22-018864.json
- Plain text: https://secwatch.observer/filing/0000950170-22-018864.txt

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