2024.04.25 -

Caliway Announced CBL-514 Phase 2 Study for Cellulite Treatment Met All Primary and Secondary Endpoints

CBL-0201EFP Phase 2 study demonstrated CBL-514 statistically significant efficacy in reducing cellulite severity scores at 4 and 12 weeks after treatment.

Caliway Announced Orphan Drug Designation Granted to CBL-514 for the Treatment of Dercum’s Disease

CBL-514 is the first and only drug to receive both Orphan Drug Designation and Fast Track designation for Dercum’s disease treatment.

2024.02.15 -

Caliway Received U.S. FDA Fast Track Designation for CBL-514 for the Treatment of Dercum’s Disease

CBL-514 is the first drug to receive Fast Track designation for Dercum’s disease treatment.

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.