2024.05.11 -

Caliway to Present the Latest Clinical Advancements at 2024 BIO International Convention

Caliway is pleased to announce its participation to share the latest clinical advancements at the upcoming 2024 BIO International Convention on Wednesday, June 5th, at 11:45 a.m. PDT.

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.