Caliway Met Dual Milestones with MSCI Global Standard Index Inclusion, and Health Canada Has Approved the Phase 3 SUPREME-01 Study

Caliway Met Dual Milestones with MSCI Global Standard Index Inclusion, and Health Canada has Approved the Phase 3 SUPREME-01 Study

Caliway (6919) has been added to the Taiwan component of the MSCI Global Standard Index, effective after market close on August 26, 2025, marking recognition from the international capital market.CBL-514's global pivotal Phase 3 study SUPREME-01, following U.S. FDA clearance,…

Caliway Announces FDA Clearance of IND Application for CBL-514 to Proceed with SUPREME-01, the First Global Pivotal Phase 3 Study for Reducing Abdominal Subcutaneous Fat

CBL-514, Caliway's first-in-class lipolysis drug candidate, has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in the U.S. and Canada in Q3 2025.CBL-514 is…

FDA clears Caliway’s CBL-514 for SUPREME-01 study for reducing abdominal subcutaneous fat

Caliway Biopharmaceuticals has announced that the FDA has granted clearance to proceed with SUPREME-01 (CBL-0301), a global, multi-centre, pivotal Phase 3 study of CBL-514, the first investigational drug for large-area localised fat reduction. This milestone marks a critical step forward in Caliway's global regulatory strategy for CBL-514.SUPREME-01 is a randomised, double-blind, placebo-controlled Phase 3 study. The primary estimand is a multic…

FDA clears Caliway’s trial of CBL-514 for localised fat reduction

The FDA has cleared Caliway Biopharmaceuticals’ pivotal Phase III trial, SUPREME-01 (CBL-0301), of its investigational drug CBL-514.The post FDA clears Caliway’s trial of CBL-514 for localised fat reduction appeared first on Clinical Trials Arena.

Caliway Announces FDA Clearance of IND Application for CBL-514 to Proceed with SUPREME-01, the First Global Pivotal Phase 3 Study for Reducing Abdominal Subcutaneous Fat - PressReach

CBL-514, Caliway’s first-in-class lipolysis drug candidate, has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in the U.S. and Canada in Q3 2025. CBL-514 is the first 505(b)(1) investigational drug with FDA clearance to proceed with a Phase 3 study for the proposed indication of “Reduction of Abdominal Subcutaneous Fat.” Caliway also plan…