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, Caliway's first-in-class lipolysis drug candidate, has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in the U.S. andCanada in Q3 2025. * CBL-514 is the first 505(b)(1) inve...
Caliway to Present First Preclinical Data on CBL-514 for GLP-1 Weight Rebound Management at BIO 2025
* Caliway to deliver a corporate presentation on June 17 at the BIO International Convention 2025, the world's largest biotech industry event. * For the first time at an international conference, Caliway will share preclinical results on CBL-514's potential new indication: combined withGLP-1 ...
Caliway Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat
* Caliway has completed the End-of-Phase 2 (EOP2) meeting with the U.S. FDA for CBL-514, the world's first investigational drug for large-area subcutaneous fat reduction developed under the 505(b)(1) regulatory pathway. * The company has received the EOP2 meeting minutes, confirming the primar...
Caliway Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat
- Caliway has completed the End-of-Phase 2 (EOP2) meeting with the U.S. FDA for CBL-514, the world's first investigational drug for large-area subcutaneous fat reduction developed under the 505(b)(1) regulatory pathway. - The company has received the EOP2 meeting minutes, confirming the ...
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 CongressUSA 2025, highlighting its promising Phase 2 study results (CBL-0201DD) for Dercum's Disease Treatment. * The Phase 2 topline results met all primary and secondary endpoints, wit...
Caliway's CBL-514 Phase 2 Study (CBL-0202) Accepted for Publication in the Aesthetic Surgery Journal
Advancing Scientific Recognition in Non-Surgical Fat Reduction * Caliway's CBL-514 Phase 2 study (CBL-0202) has been accepted for publication inAesthetic Surgery Journal (ASJ), the top-ranked journal in aesthetic medicine and plastic surgery. * Clinical data (ITT population) showed that over ...
Caliway Announces CBL-514 Second Phase 2b Study Results (CBL-0205) Met Endpoints
* CBL-514, the world's first investigational drug for large-area localized fat reduction, has demonstrated significant efficacy in its second and the last Phase2b study (CBL-0205) before Phase 3. * 54.2% of participants in the CBL-514 group achieved at least 20% fat volume reduction four week...
Caliway to Present CBL-514 Phase 2b Study Results for Subcutaneous Fat Reduction at IMCAS 2025 in Paris
* The findings from the CBL-0204 Phase 2b clinical trial have been selected for presentation at IMCAS, the premier global congress in aesthetic medicine. The data will be highlighted in both the 2025 focus session on advances in fat reduction therapies and further detailed in the Non-surgical B...
Caliway Biopharmaceuticals Included in FTSE TWSE Taiwan Eight Industries and Mid-Cap 100 Indices
NEW TAIPEI CITY, Dec. 6, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals Co., Ltd. (TWSE-6919) is proud to announce its inclusion in the FTSE TWSE Taiwan Mid-Cap 100 Index and the FTSE TWSE Taiwan Eight Industries Index, two prestigious benchmarks jointly compiled by FTSE Russell and the Taiwan S...
Caliway Announced EMA Orphan Drug Designation Granted to CBL-514 for Dercum's Disease Treatment
- CBL-514 is the first and only drug to receive EMA Orphan Drug Designation for Dercum's disease treatment. - CBL-514 received both FDA Orphan Drug Designation and Fast Track designation for Dercum's disease treatment earlier this year. - CBL-514 Phase 2 study for Dercum's disease showed that it c...
Caliway Completed CBL-514 Phase 2b Study (CBL-0205) for Subcutaneous Fat Reduction
* The first and only lipolytic injectable for large area – CBL-514's last Phase2b study has been completed * Both CBL-514 Phase 2b studies used efficacy assessment tools, AFRS and MRI, in accordance with the U.S. FDA recommendation * CBL-514 Pivotal Phase 3 study is expected to initiate subj...
Caliway Announces the Initiation of Subject Recruitment in CBL-514 Phase 2b Study for Dercum's Disease
NEW TAIPEI CITY, Sept. 3, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the subject recruitment of CBL-514 Phase2b study for Dercum's disease (CBL-0202 DD Phase2b study, NCT06303570) has been initiated. The study results are anticipated in Q4 2025. CBL-0202DD study i...
Caliway to Present the Latest Clinical Advancements at 2024 BIO International Convention
NEW TAIPEI CITY, May 11, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) is pleased to announce its participation to share the latest clinical advancements at the upcoming 2024 BIO International Convention onWednesday, June 5th, at 11:45 a.m. PDT. The presentation will take place in Com...
Caliway Announced CBL-514 Phase 2 Study for Cellulite Treatment Met All Primary and Secondary Endpoints
* CBL-514 is the first product to treat cellulite at the raised areas. * Currently, there is no effective and safe cellulite treatment on the market. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034. * CBL-0201EFP Phase 2 study demonstrated CBL-514 sta...
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. NEW TAIPEI CITY, March 3, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orp...
Caliway Received First Approval of CBL-514 Pivotal Phase 3 Study Application for Subcutaneous Fat Reduction
NEW TAIPEI CITY, Jan. 23, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announces that Australian Bellberry HREC has approved Caliway's application to initiate CBL-514's Pivotal Phase 3 study (CBL-0301) for subcutaneous fat reduction. "We are all delighted to see CBL-514 showing its ...
Caliway Received First Approval of CBL-514 Pivotal Phase 3 Study Application for Subcutaneous Fat Reduction
NEW TAIPEI CITY, Jan. 23, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announces that 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. "We are all delighted to see CBL-514 show...
Caliway Announces FDA Acceptance of CBL-514 IND Application for Placebo-Controlled Phase 2 Study to treat Dercum's Disease
NEW TAIPEI CITY, Jan. 8, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the United States Food and Drug Administration (U.S. FDA) has accepted the CBL-514 Investigational New Drug (IND) application of CBL-0202 DD Phase 2 Study to treat Dercum's Disease. Dercum's disease...
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). NEW TAIPEI CITY, Dec. 26, 2023 /PRNewswire/ -- Caliway Biopharmaceuticals (Cal...
Caliway Closes Oversubscribed Capital Raise and Secures Over $100M to Advance CBL-514 Pivotal Phase 3 Study in Subcutaneous Fat Reduction
TAIPEI, Dec. 16, 2023 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that it has closed an oversubscribed capital raise, securing over$100M by issuing 8 million new shares. The new funding will enable Caliway to advance the clinical development of its lead pipeline CBL-514, a sma...
