CRISPR Therapeutics Highlights Strategic Priorities and 2024 Outlook

ZUG, Switzerland and BOSTON, Jan. 08, 2024 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today highlighted its strategic priorities and 2024 outlook as the Company enters its next phase of growth.

“We had a landmark year in 2023, marked by the first-ever approval of a CRISPR-based gene-editing therapy in addition to entering the clinic with our in vivo therapies,” said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. “As we look ahead to 2024, we continue to drive forward our programs and expand our pipeline with the goal of delivering paradigm-shifting gene editing therapies to patients. We are well positioned to execute on our clinical trials across various therapeutic areas, including oncology, autoimmune, cardiovascular and diabetes, setting up a catalyst-rich 12-18 months for the company. In parallel, we are continuously innovating on our platform with next-generation gene editing and delivery technologies that could enable us to address even more diseases with potentially curative medicines. Even in this challenging macroeconomic environment for biotech companies, our strong capital position and efficient operating model provides us with a competitive advantage to expand upon our leadership in the space.”

Strategic Priorities and 2024 Outlook

CASGEVY (exagamglogene autotemcel [exa-cel])

• Received regulatory approvals for CASGEVY in the fourth quarter of 2023 in the U.S. for sickle cell disease (SCD) and in Great Britain and Bahrain for the treatment of SCD and transfusion-dependent beta thalassemia (TDT); also received a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for CASGEVY for both SCD and TDT from the European Medicines Agency (EMA). Exa-cel is the first therapy to emerge from a strategic partnership between CRISPR Therapeutics and Vertex Pharmaceuticals. Vertex leads global development, manufacturing, regulatory and commercialization of CASGEVY with support from CRISPR Therapeutics.
  
• The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2024, for CASGEVY in TDT. Additional regulatory submissions for CASGEVY are currently under review in Switzerland and the Kingdom of Saudi Arabia, with the submission in Canada planned for the first half of 2024.