Business
CRISPR Therapeutics Provides Business Update and Reports Second Quarter 2023 Financial Results
-FDA accepted Biologics License Applications (BLAs) for exagamglogene autotemcel (exa-cel) for severe Sickle Cell Disease (SCD) and Transfusion-Dependent Beta
About this update from Crispr Therapeutics Ag
[{"type":"text","content":"-FDA accepted Biologics License Applications (BLAs) for exagamglogene autotemcel (exa-cel) for severe Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT); Priority Review for SCD and Standard Review for TDT- -PDUFA target action date of December 8, 2023, for SCD and March 30, 2024, for TDT- -Enrollment and dosing ongoing for CTX110®, targeting CD19+ B-cell malignancies, and CTX130™, targeting CD70 for the treatment of T cell lymphomas- -Enrollment ongoing and dosing initiated 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 the clinic this year- ZUG, Switzerland and BOSTON, Aug. 07, 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 second quarter ended June 30, 2023. “The second quarter of 2023 was a period of continued substantial progress toward our goal of delivering innovative gene edited therapies to patients, including the FDA’s acceptance of the exa-cel BLAs for SCD and TDT and the presentation of updated interim exa-cel trial data at EHA, which demonstrated transformative, consistent and durable benefit to patients,” said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. “In parallel, we continue to advance our various clinical programs rapidly, including our next-generation CAR T candidates. In addition, we plan to initiate a clinical trial for CTX310, our lead in vivo program targeting ANGPTL3, this year. All together, we are well-positioned to realize our mission of bringing transformative and potentially curative therapies to patients in need and look forward to continued momentum in the months ahead.” Recent Highlights and Outlook Hemoglobinopathies In June, CRISPR Therapeutics and Vertex Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) accepted the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) for severe sickle cell disease (SCD)...