secwatch.observer — SEC 8-K summary
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Issuer:     CRISPR Therapeutics AG (CRSP)
CIK:        0001674416
Form:       8-K
Filed at:   2022-09-27T23:59:59+00:00
Accession:  0000950170-22-018864
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1674416/000095017022018864/0000950170-22-018864-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1674416/000095017022018864/crsp-20220927.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-018864

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer