---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-027129"
form_type: "8-K"
ticker: "CRSP"
cik: "0001674416"
company_name: "CRISPR Therapeutics AG"
filed_at: "2023-06-09T23:59:59+00:00"
generated_at: "2026-06-14T03:59:09.488731+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts exa-cel BLAs; pivotal trials meet primary endpoints in SCD and TDT

## Summary
- FDA granted Priority Review for SCD (PDUFA Dec 8, 2023) and Standard Review for TDT (PDUFA Mar 30, 2024).
- In TDT, 24/27 (88.9%) achieved transfusion-independence ≥12 months; mean duration 20.5 months.
- In SCD, 16/17 (94.1%) achieved freedom from vaso-occlusive crises ≥12 months; mean duration 18.7 months.
- Safety profile consistent with busulfan conditioning; no deaths or discontinuations related to exa-cel.
- Data from 83 patients (48 TDT, 35 SCD) with follow-up up to 43.7 months presented at EHA 2023.

## SEC filing metadata
- accession: 0000950170-23-027129
- form_type: 8-K
- ticker: CRSP
- cik: 0001674416
- company_name: CRISPR Therapeutics AG
- filed_at: 2023-06-09T23:59:59+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/1674416/000095017023027129/0000950170-23-027129-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1674416/000095017023027129/crsp-20230608.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-027129
- JSON: https://secwatch.observer/filing/0000950170-23-027129.json
- Plain text: https://secwatch.observer/filing/0000950170-23-027129.txt

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