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03
2026
2026.03.19 -
Caliway Selected to Present Preclinical Data on CBL-514 in Combination with GLP-1R Therapy at ECO 2026
Preclinical data on Caliway’s fat reduction drug candidate CBL-514 in combination with GLP-1R-based weight-loss therapies has been selected for oral presentation at the European Congress on Obesity (ECO 2026). The presentation will be delivered by Arya M. Sharma, MD, Caliway’s scientific advisor and a globally recognized authority in obesity medicine, who will discuss CBL-514’s fat-reduction efficacy, differentiated mechanism, and potential scientific value as a complementary approach to current weight-loss therapies.
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02
2026
2026.02.23 -
Caliway Completes Australian HREC Submission for CBL-0206, Advancing Asia-Pacific Clinical Strategy
CBL-0206 Phase 2 study of Caliway’s first-in-class large-area localized fat reduction drug, CBL-514, has completed Australian HREC submission. The study will be conducted in Taiwan and Australia, with an estimated enrollment of approximately 250 participants. The study aims to expand safety and efficacy data in Asian populations, supporting future NDA filings and Caliway’s global and regional dual-track licensing strategy
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12
2025
2025.12.25 -
Caliway’s Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA–Based Weight-Loss Therapies
Caliway has completed submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of CBL-514 for weight management (CBL-0201WR Phase 2).
The study will evaluate CBL-514 in combination with Zepbound® (Eli Lilly) in subjects with obesity or overweight. This submission accelerates the clinical development of CBL-514 in combination with GLP-1R agonist (GLP-1RA) therapies and expands the Company’s R&D footprint in the global weight management field. -
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.
