Brief: Vertex And Crispr Therapeutics Announce Us FDA Approval Of Casgevy™ (Exagamglogene Autotemcel) For The Treatment Of Sickle Cell Disease

Crispr Therapeutics AG

08/12/2023 18:36

Dec 8 (Reuters) - CRISPR Therapeutics AG  CRSP.BN :
    * VERTEX AND CRISPR THERAPEUTICS ANNOUNCE US FDA APPROVAL OF
CASGEVY™ (EXAGAMGLOGENE AUTOTEMCEL) FOR THE TREATMENT OF SICKLE
CELL DISEASE
    * CRISPR THERAPEUTICS AG - MULTIPLE AUTHORIZED TREATMENT
CENTERS
ACTIVATED
    * CRISPR THERAPEUTICS AG - USE OF CASGEVY FOR TREATMENT OF
TDT IN
U.S. REMAINS INVESTIGATIONAL
    * CRISPR THERAPEUTICS - ABOUT 16,000 PATIENTS 12 YEARS OF
AGE AND
OLDER WITH SEVERE SICKLE CELL DISEASE MAY NOW BE ELIGIBLE FOR
THIS ONE-TIME TREATMENT
    * CRISPR THERAPEUTICS AG - USE OF CASGEVY FOR TREATMENT OF
TDT IN
U.S. REMAINS INVESTIGATIONAL
    * CRISPR: VERTEX IS ENGAGING WITH EXPERIENCED HOSPITALS TO
ESTABLISH NETWORK OF AUTHORIZED TREATMENT CENTERS THROUGHOUT
U.S. TO OFFER CASGEVY TO PATIENTS
    * CRISPR THERAPEUTICS AG - VERTEX SUBMITTED BLA TO U.S. FDA
FOR
POTENTIAL USE OF CASGEVY, ASSIGNED PDUFA TARGET ACTION DATE OF
MARCH 30, 2024
    * CRISPR THERAPEUTICS AG - CASGEVY IS CURRENTLY UNDER REVIEW
BY
EUROPEAN MEDICINES AGENCY AND SAUDI FOOD AND DRUG AGENCY FOR
BOTH SCD AND TDT
    * CRISPR THERAPEUTICS AG - IN CONJUNCTION WITH FDA APPROVAL
OF
CASGEVY, VERTEX WILL MAKE A $200 MILLION MILESTONE PAYMENT TO
CRISPR
    * CRISPR THERAPEUTICS AG: VERTEX WILL RECORD 60 PERCENT OF
RESEARCH AND DEVELOPMENT EXPENSES, NET OF CRISPR'S 40 PERCENT
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