Vertex And CRISPR Therapeutics Announce U.S. FDA Approval Of CASGEVY For The Treatment Of Sickle Cell Disease
Portfolio Pulse from Benzinga Newsdesk
Vertex Pharmaceuticals and CRISPR Therapeutics announced FDA approval of CASGEVY, a CRISPR-based gene-editing therapy for sickle cell disease (SCD) in patients 12+ with severe symptoms. This marks the first U.S. approval of a CRISPR therapy, potentially benefiting 16,000 patients. Vertex will make a $200 million milestone payment to CRISPR and handle global development, manufacturing, and commercialization of CASGEVY, recording 100% of revenues and costs, and sharing net profits or losses with CRISPR. CASGEVY is also under review in Europe and Saudi Arabia, and a PDUFA date for TDT treatment in the U.S. is set for March 30, 2024.
December 08, 2023 | 5:54 pm
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POSITIVE IMPACT
CRISPR Therapeutics will receive a $200 million milestone payment from Vertex Pharmaceuticals following the FDA approval of CASGEVY, a CRISPR-based gene-editing therapy for SCD. CRISPR will share in the net profits or losses from CASGEVY with Vertex.
CRISPR Therapeutics is poised to benefit from the FDA approval of CASGEVY through the $200 million milestone payment and future profit sharing. This approval validates CRISPR's technology and could lead to increased investor confidence and a positive short-term impact on the stock price.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 90
POSITIVE IMPACT
Vertex Pharmaceuticals will lead the commercialization of CASGEVY, the newly FDA-approved CRISPR therapy for SCD, and will make a $200 million payment to CRISPR Therapeutics. Vertex will record all revenues and costs associated with CASGEVY and share net profits or losses with CRISPR.
The FDA approval of CASGEVY is a significant milestone for Vertex, likely to have a positive short-term impact on the stock. The approval opens up a new revenue stream and demonstrates Vertex's leadership in innovative treatments. The $200 million payment to CRISPR is a considerable expense but reflects a strategic investment in the therapy's future success.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 90