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CRISPR Therapeutics reports $99M Casgevy sales as paediatric approvals widen and CTX310 gains RMAT status

🇺🇸 CRISPR Therapeutics AG (CRSP) · Mon 02 Nov 2026

Third-quarter Casgevy revenue rose 30% on the previous quarter, while new paediatric clearances and two FDA RMAT designations marked regulatory progress across the pipeline.

CRISPR Therapeutics reported its third-quarter 2026 results on 2 November, citing Casgevy revenue of $99 million. The company said this was 30% higher than in the previous quarter.

The company also noted new paediatric approvals for Casgevy in sickle cell disease and transfusion-dependent beta thalassaemia. The UK Medicines and Healthcare products Regulatory Agency (MHRA) cleared use from age 5 upwards, while the United Arab Emirates and Bahrain approved it from age 2 upwards.

On the pipeline, the US Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designations to CTX310 for severe hypertriglyceridaemia and for elevated LDL cholesterol. As general context, RMAT is a US designation intended to speed development and review of promising regenerative medicine therapies for serious conditions, and it allows more frequent interaction with the agency.

CRISPR Therapeutics added that enrolment in the Phase 2 study of CTX611 in patients undergoing knee arthroplasty is complete. The summary available does not give further detail on timelines, trial design or other financial results.

What it means for your team

  • Market-access teams should note the lower age thresholds now authorised in the UK (5+) and in the UAE and Bahrain (2+), which widen the eligible paediatric populations in those markets.
  • Regulatory teams tracking gene-editing products can use the MHRA and Gulf approvals as reference points for paediatric labelling decisions in other jurisdictions.
  • The two RMAT designations for CTX310 signal FDA engagement on in vivo gene editing for cardiometabolic indications, a different area from Casgevy's haematology focus.
  • Pharmacovigilance teams should expect broader paediatric exposure to Casgevy as access expands, with attendant post-authorisation monitoring needs.

Company's press release (SEC filing): CRISPR Therapeutics AG ↗

Article written by VigiEye from the official source (CRISPR Therapeutics AG). Claims are the company's own. AI-assisted; check the source before acting.

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