TPE:6919

2 stories mentioning TPE:6919Updated 18d ago

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Caliway Completes FDA IND Filing for Phase 3b CBL-514 Trial of Abdominal Fat Reduction Drug

Caliway Biopharmaceuticals (TPE:6919) completed its U.S. FDA IND submission for a Phase 3b long-term follow-up study of its abdominal subcutaneous fat reduction drug, according to a Wednesday Taiwan Exchange filing.The study, dubbed CBL-0303, is designed to evaluate long-term safety and maintenance of efficacy of the drug called CBL-514, before the trail.It is expected to enroll around 300 participants in the United States. The protocol also includes an optional re-treatment phase for eligible patients, the filing said.

TPE:6919

Asia62d ago

Caliway Biopharma Seeks US FDA Nod for Fat Reduction Drug's Phase 3 Trial; Shares Rise 5%

Caliway Biopharmaceuticals (TPE:6919) completed a U.S. FDA IND submission for the phase three clinical trial for a fat reduction drug, according to a Monday Taiwan Exchange filing.Shares rose about 5% in Tuesday's afternoon trade.The study will evaluate the drug, dubbed CBL-514, for abdominal subcutaneous fat reduction.The randomized, double-blind, placebo-controlled trial will enroll about 320 participants across the U.S., Canada and Australia.The company said the application was submitted on Monday and is currently under review, the filing said.

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