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09
2025
2025.09.19 -
Caliway Participates in EASD 2025 – CBL-514 Demonstrates Unique Fat-Reduction Mechanism and Differentiated Advantage in Combination with GLP-1R Therapy
Caliway shared findings from two recently completed preclinical studies (OI22, OI23) with participating experts, highlighting four differentiated advantages of CBL-514 when combined with GLP-1R drugs such as Tirzepatide.
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08
2025
2025.08.12 -
Caliway Met Dual Milestones with MSCI Global Standard Index Inclusion, and Health Canada has Approved the Phase 3 SUPREME-01 Study
Caliway Biopharmaceuticals (TWSE: 6919) announced that, the Company was added to the MSCI Global Standard Index, effective after the Taiwan market close on August 26, 2025. Caliway also announced that its first-in-class injectable drug candidate for large-area fat reduction, CBL-514, has now received approval from Health Canada for its global pivotal Phase 3 study SUPREME-01.
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07
2025
2025.07.28 -
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 has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study.
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07
2025
2025.07.11 -
Caliway Files Canadian CTA for Global Pivotal Phase 3 SUPREME-01 Study of CBL-514, with U.S.-Canada Recruitment to Begin in Q3
Caliway has submitted the CTA to Health Canada for SUPREME-01, a global, multicenter, pivotal Phase 3 study of CBL-514 for subcutaneous fat reduction, following the IND submission to the FDA.
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06
2025
2025.06.29 -
Caliway Completed FDA IND Submission for Global Pivotal Phase 3 Study SUPREME-01 of CBL-514 for Fat Reduction, Advancing NDA on Schedule
Caliway has submitted the IND application to the U.S. FDA for SUPREME-01 (CBL-0301), the first global, multicenter, pivotal Phase 3 study of CBL-514 for subcutaneous fat reduction, with a planned enrollment of 300 subjects.
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06
2025
2025.06.10 -
Caliway to Present First Preclinical Data on CBL-514 for GLP-1 Weight Rebound Management at BIO 2025
Caliway Biopharmaceuticals will deliver an oral presentation at the 2025 BIO International Convention on June 17, highlighting the company’s latest progress in R&D and pipeline development.
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05
2025
2025.05.14 -
Caliway Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat
Caliway has completed the EOP2 meeting with the U.S. FDA for CBL-514, confirming the primary endpoints and pivotal study design for the Approval in Reduction of Abdominal Subcutaneous Fat.
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04
2025
2025.04.17 -
Caliway Selected to Present CBL-514 Phase 2 Study Results for Dercum’s Disease at World Orphan Drug Congress USA 2025
CBL-514, Caliway’s novel small molecule drug, was selected for data presentation at the World Orphan Drug Congress USA 2025, highlighting its promising Phase 2 study results for Dercum’s Disease Treatment.
