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FINWIRES

Caliway Wins US FDA Clearance to Advance Phase 3b Trial of Fat-Reduction Drug

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Caliway Biopharmaceuticals (TPE:6919) said the U.S. Food and Drug Administration has completed its 30-day review of an investigational new drug application for a Phase 3b study of CBL-514, allowing the trial to proceed.

CBL-514 is an injectable treatment for reducing abdominal fat, according to a Friday Taiwan Exchange filing.

The study, known as CBL-0303, will assess the long-term safety and durability of the drug's fat-reduction effect in participants who completed the company's Phase 3 trials.

The company has not yet begun the new drug application process, the filing said.

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