Caliway Unveils Latest OI25 Animal Study Data for CBL-514 in Combination with GLP-1R-Based Weight-Loss Therapies at ADA 2026, Demonstrating Dual Potential to Attenuate Post-Discontinuation Weight Regain and Improve Metabolic Health
Backed by International Authority — Caliway's latest preclinical data on its proprietary localized fat reduction candidate, CBL-514, in combination with GLP–1R–based weight–loss therapies, were presented at the American Diabetes Association 2026 Scientific Sessions (ADA 2026). The findings were d...
Caliway Makes First ECO 2026 Oral Presentation on Preclinical Data of CBL-514 in Combination with GLP-1R-Based Weight-Loss Therapies, Attracting Strong Interest from International Experts and Global Pharmaceutical Companies for Its Systemic Metabolic Effects
CBL-514, when combined separately with two leading GLP-1R-based weight-loss therapies, semaglutide and tirzepatide, demonstrated enhanced weight loss, attenuated post-discontinuation weight regain, and greater reductions in subcutaneous and visceral fat in animal studies. The presentation also ma...
Caliway's Fat Reduction Drug CBL-514 Phase 2 Clinical Results Accepted by ASJ. CBL-0204's Demonstrated Efficacy and Safety Gain Further Academic Recognition
* Clinical results from Caliway's CBL-0204 Phase 2b study of its fat reduction drug candidate CBL-514 for localized fat reduction have been accepted by theAesthetic Surgery Journal (ASJ), a leading academic journal in aesthetic medicine and plastic surgery. * Following the publication of CBL-...
Caliway Selected to Present Preclinical Data on CBL-514 in Combination with GLP-1R Therapy at the American Diabetes Association's 2026 Scientific Sessions
* Preclinical research on Caliway's fat reduction drug candidate CBL-514 in combination with GLP-1R-based weight-loss therapies has been selected for presentation at the American Diabetes Association's 2026 Scientific Sessions. * The presentation will be delivered by W. Timothy Garvey, MD, a g...
Caliway's Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies
* Caliway has completed submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of CBL-514 for weight management (CBL-0201WR Phase 2). * The study will evaluate CBL-514 in combination with Zepbound® (Eli Lilly) in...
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...
