CRISPR Therapeutics AG CRSP shares are trading higher Tuesday after the company and Vertex Pharmaceuticals Inc VRTX announced the U.S. Food and Drug Administration granted exagamglogene autotemcel (exa-cel) a rolling review for the potential treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
Vertex will submit its biologics licensing application for exa-cel, beginning in November, and expects to complete the submission by the end of the first quarter of 2023. The company is on track to submit marketing applications to the European Medicines Agency by the end of the year.
Exa-cel is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy. It's being investigated in multiple ongoing clinical trials as a potential one-time therapy for patients with either SCD or TDT.
Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. Exa-cel represents the first potential treatment to emerge from the joint research program.
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CRSP Price Action: CRISPR has a 52-week high of $86.95 and a 52-week low of $42.51.
The stock was up 3.11% at $63 Tuesday morning, according to Benzinga Pro.
Photo: Chokniti Khongchum from Pixabay.
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