2024.01.23 -

Caliway Received First Approval of CBL-514 Pivotal Phase 3 Study Application for Subcutaneous Fat Reduction

Australian Bellberry HREC has approved Caliway’s application to initiate CBL-514’s Pivotal Phase 3 study (CBL-0301 Phase 3) for subcutaneous fat reduction.

2024.01.07 -

Caliway Announces FDA Acceptance of CBL-514 IND Application for Placebo-Controlled Phase 2 Study to treat Dercum’s Disease

Caliway announced that the U.S. FDA has accepted the CBL-514 IND application of CBL-0202 DD Phase 2 Study to treat Dercum’s Disease.

2023.12.27 -

Caliway to Present CBL-514 Phase 2 Study Results for Subcutaneous Fat Reduction at IMCAS 2024

CBL-514 Phase 2 Study Results for local fat reduction demonstrated 85.7% and 76.2% of participants lost at least 150mL and 200mL of abdominal subcutaneous fat in the treated area after receiving CBL-514 treatment(s).

2023.12.15 -

Caliway Closes Oversubscribed Capital Raise and Secures Over $100M to Advance CBL-514 Pivotal Phase 3 Study in Subcutaneous Fat Reduction

Caliway announced that it has closed an oversubscribed capital raise, securing over $100M by issuing 8 million new shares.

Caliway's CBL-514 Achieved Better Efficacy than Liposuction, Reducing over 300mL of Subcutaneous Fat on Average in CBL-0202 Study

CBL-0202 Phase 2 study results met all the primary and secondary endpoints.

Caliway Announces the Completion of Subject Recruitment in the CBL-0201EFP Phase 2-stage 2 Study Evaluating the CBL-514 in Cellulite Treatment

Caliway announced the completion of subject recruitment in the CBL-0201EFP Phase 2-stage 2 study.

The Positive Topline Results from the CBL-514 Phase 2 Study for Dercum’s Disease Showed 64.5% of Painful Lipomas with Complete Clearance or Dimensions Reduction of more than 50% and Significantly Reduced Pain by 4.7 Points

CBL-0201DD Phase 2 study met the primary and all secondary endpoints.

Caliway Receives IND approval from the U.S. FDA for the CBL-0205 Phase 2b Study Evaluating CBL-514 in Abdominal Subcutaneous Fat Reduction

Caliway announces that the U.S. FDA has approved the company’s IND application for CBL-514 injection’s CBL-0205 Phase 2b Study.