US FDA Clears Phase 3b Study of Caliway Biopharma's CBL-514 Fat-Reduction Drug

Caliway Biopharmaceuticals (TPE:6919) said the US Food and Drug Administration has allowed its investigational new drug application for CBL-0303, a Phase 3b long-term follow-up study of CBL-514 for reducing abdominal subcutaneous fat, to proceed after the 30-day review period. The study in the U.S. is expected to enroll about 300 participants who completed the company's pivotal Phase 3 trials to evaluate the long-term safety and durability of CBL-514's efficacy. It will assess the drug's long-term safety and whether its effectiveness in reducing abdominal subcutaneous fat is maintained over time, with eligible participants also able to receive re-treatment.