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.

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.

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.

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.

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.

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.

2025.03.20 -

Caliway Selected to Present CBL-514 Phase 2b Study Results at AMWC 2025 in Monaco

Caliway’s localized fat reduction drug, CBL-514, has been selected for presentation at the globally renowned AMWC Aesthetic & Anti-Aging Medicine World Congress under the "Body & Fat Treatment" session, highlighting CBL-0204 Phase 2b study results.

Caliway’s CBL-514 Phase 2 Study (CBL-0202) Accepted for Publication in the Aesthetic Surgery Journal

CBL-514 Phase 2 study (CBL-0202) has been accepted for publication in Aesthetic Surgery Journal (ASJ).