Caliway Achieves MSCI Global Standard Index Inclusion and Health Canada Approval for Phase 3 Study

What's Happening?

Caliway Biopharmaceuticals has been added to the Taiwan component of the MSCI Global Standard Index, effective after market close on August 26, 2025. This inclusion marks a significant recognition from the international capital market, reflecting the company's market capitalization, liquidity, and financial transparency. Additionally, Caliway's injectable drug candidate, CBL-514, has received approval from Health Canada for its Phase 3 SUPREME-01 study, following prior clearance by the U.S. FDA. The study aims to recruit 300 participants across the U.S. and Canada, focusing on the reduction of abdominal subcutaneous fat. The study is set to begin in Q3 2025.

Why It's Important?

The inclusion in the MSCI Global Standard Index is expected to attract investment from large-scale international funds, enhancing Caliway's visibility in the global market. The approval of the Phase 3 study by Health Canada signifies a major step forward in the development of CBL-514, potentially offering a non-surgical fat reduction treatment. This could have significant implications for the aesthetic medicine industry, providing a new option for individuals seeking fat reduction without surgery. The successful execution of this study could lead to future marketing approval, expanding Caliway's market reach and influence.

What's Next?

Caliway plans to commence recruitment for the SUPREME-01 study in Q3 2025, with 29 clinical sites across the U.S. and Canada. The study will evaluate the efficacy of CBL-514 in reducing abdominal fat, using MRI measurements and patient-reported assessments. If successful, the study could pave the way for marketing approval, allowing Caliway to offer its innovative treatment globally. The company is also exploring additional indications for CBL-514, including cellulite reduction and weight management.

Beyond the Headlines

Caliway's advancements highlight the growing trend towards non-invasive medical treatments, reflecting a shift in consumer preferences towards less invasive procedures. The company's focus on disciplined execution and innovation positions it as a potential leader in the biopharmaceutical industry, particularly in aesthetic medicine. The success of CBL-514 could influence future drug development strategies, emphasizing the importance of patient-focused outcomes.