Business
CRISPR Therapeutics Provides Business Update and Reports First Quarter 2023 Financial Results
-Regulatory submissions complete for exagamglogene autotemcel (exa-cel), formerly known as CTX001™, in the U.S. for transfusion-dependent beta thalassemia
About this update from Crispr Therapeutics Ag
[{"type":"text","content":"-Regulatory submissions complete for exagamglogene autotemcel (exa-cel), formerly known as CTX001™, in the U.S. for transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD)- -EU and U.K. submissions validated by European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA); exa-cel has been granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the MHRA- -Enrollment and dosing ongoing for CTX110®, targeting CD19+ B-cell malignancies, and CTX130™, targeting CD70 for the treatment of T cell lymphomas- -Initiated clinical trials for next generation CAR T candidates, CTX112™ targeting CD19+ B-cell malignancies and CTX131™, targeting CD70+ solid tumors- -Enrollment and dosing ongoing in a Phase 1/2 clinical trial of VCTX211™ for the treatment of Type 1 Diabetes (T1D)- -Continues to advance its lead in vivo program, CTX310™, targeting angiopoietin-related protein 3 (ANGPTL3) into clinical trials this year- ZUG, Switzerland and BOSTON, May 08, 2023 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today reported financial results for the first quarter ended March 31, 2023. “In the first quarter of 2023, we continued strong momentum across our portfolio. We and our partner Vertex have now completed regulatory submissions for exa-cel in the United States, European Union and United Kingdom, positioning exa-cel to potentially become the first approved CRISPR-based therapy in the world, a remarkable pace of progress considering the discovery of the CRISPR platform took place a little more than a decade ago,” said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. “In parallel, we continue to drive our portfolio programs, including the initiation of clinical trials for our next-generation CAR T candidates, CTX112 and CTX131. In addition, we expect to advance CTX310, our lead in vivo program targeting ANGPTL3, into clinical trials later this year. We are well-positioned to drive towards our mission of bringing transformative and potentially curative therapies to patients in need.” Recent Highlights and Outlook Hemoglobinopathies In April, CRISPR Therapeutics and Vertex Pharmaceuticals announced the completion of ...