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Caliway’s Asia-Pacific Phase 2 study of CBL-514 for reduction of abdominal subcutaneous fat, CBL-0206, has received approval from Australia’s HREC to proceed, officially advancing the Company’s Asia-Pacific clinical strategy.
Caliway has completed the U.S. FDA IND submission for SUPREME-02, the second global multi-national, multi-center pivotal Phase 3 study of CBL-514 for reduction of abdominal subcutaneous fat, progressing on schedule according to the Company’s development plan.
Clinical results from CBL-0204 Phase 2b, a study of its first-in-class large-area localized fat reduction drug candidate, CBL-514, for subcutaneous fat reduction, have been accepted by the Aesthetic Surgery Journal (ASJ), a globally recognized authority in aesthetic medicine.
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 globally recognized authority in obesity and metabolic medicine and a scientific advisor to Caliway.
reclinical data on Caliway’s fat reduction drug candidate CBL-514 in combination with GLP-1R-based weight-loss therapies has been selected for oral presentation at the European Congress on Obesity (ECO 2026). The presentation will be delivered by Arya M. Sharma, MD, Caliway’s scientific advisor and a globally recognized authority in obesity medicine, who will discuss CBL-514’s fat-reduction efficacy, differentiated mechanism, and potential scientific value as a complementary approach to current ...
Caliway Completes Australian HREC Submission for CBL-0206, Advancing Asia-Pacific Clinical Strategy
CBL-0206 Phase 2 study of Caliway’s first-in-class large-area localized fat reduction drug, CBL-514, has completed Australian HREC submission. The study will be conducted in Taiwan and Australia, with an estimated enrollment of approximately 250 participants. The study aims to expand safety and efficacy data in Asian populations, supporting future NDA filings and Caliway’s global and regional dual-track licensing strategy
aliway 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 subjects with obesity or overweight. This submission accelerates the clinical development of CBL-514 in combination with GLP-1R agonist (GLP-1RA) therapies and expands the Company’s R&D footprint in the global w ...
Caliway shared findings from two recently completed preclinical studies (OI22, OI23) with participating experts, highlighting four differentiated advantages of CBL-514 when combined with GLP-1R drugs such as Tirzepatide.
Caliway Biopharmaceuticals (TWSE: 6919) announced that, the Company was added to the MSCI Global Standard Index, effective after the Taiwan market close on August 26, 2025. Caliway also announced that its first-in-class injectable drug candidate for large-area fat reduction, CBL-514, has now received approval from Health Canada for its global pivotal Phase 3 study SUPREME-01.
CBL-514 has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study.
Caliway has submitted the CTA to Health Canada for SUPREME-01, a global, multicenter, pivotal Phase 3 study of CBL-514 for subcutaneous fat reduction, following the IND submission to the FDA.
Caliway has submitted the IND application to the U.S. FDA for SUPREME-01 (CBL-0301), the first global, multicenter, pivotal Phase 3 study of CBL-514 for subcutaneous fat reduction, with a planned enrollment of 300 subjects.
Caliway to Present First Preclinical Data on CBL-514 for GLP-1 Weight Rebound Management at BIO 2025
Caliway Biopharmaceuticals will deliver an oral presentation at the 2025 BIO International Convention on June 17, highlighting the company’s latest progress in R&D and pipeline development.
Caliway has completed the EOP2 meeting with the U.S. FDA for CBL-514, confirming the primary endpoints and pivotal study design for the Approval in Reduction of Abdominal Subcutaneous Fat.
CBL-514, Caliway’s novel small molecule drug, was selected for data presentation at the World Orphan Drug Congress USA 2025, highlighting its promising Phase 2 study results for Dercum’s Disease Treatment.
Caliway Selected to Present CBL-514 Phase 2b Study Results at AMWC 2025 in Monaco
Caliway’s localized fat reduction drug, CBL-514, has been selected for presentation at the globally renowned AMWC Aesthetic & Anti-Aging Medicine World Congress under the "Body & Fat Treatment" session, highlighting CBL-0204 Phase 2b study results.
Caliway’s CBL-514 Phase 2 Study (CBL-0202) Accepted for Publication in the Aesthetic Surgery Journal
CBL-514 Phase 2 study (CBL-0202) has been accepted for publication in Aesthetic Surgery Journal (ASJ).
Caliway Biopharmaceuticals Added to MSCI World Small Cap Index, Reinforcing Global Standing
Caliway has been added to the MSCI World Small Cap Index, as announced today by MSCI (Morgan Stanley Capital International) in its latest quarterly review.
Caliway Announces CBL-514 Second Phase 2b Study Results (CBL-0205) Met Endpoints
Caliway announced today that CBL-514’s second Phase 2b clinical study (CBL-0205) successfully met its primary and all critical secondary efficacy endpoints.
Caliway Presented CBL-0204 Phase 2b Study Results of CBL-514 at IMCAS 2025 in Paris
Innovative Non-Surgical Fat Reduction Treatment Gains International Attention
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 Body Contouring session through an oral presentation.
CBL-514 Phase 2b study for subcutaneous fat reduction (CBL-0204 Phase 2b study) met all the primary and secondary efficacy endpoints in the FAS (Full analysis set) and PP (Per-protocol) population analysis.
Caliway Biopharmaceuticals Included in FTSE TWSE Taiwan Eight Industries and Mid-Cap 100 Indices
Caliway is proud to announce its inclusion in the FTSE TWSE Taiwan Mid-Cap 100 Index and the FTSE TWSE Taiwan Eight Industries Index.
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.
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 Phase 2b study has been completed
Caliway Successfully Lists on Taipei Exchange Following IPO
Caliway is pleased to announce the successful completion of its initial public offering (IPO) and up-listing from the Emerging Stock Market to the Taipei Exchange (TWSE-6919).
Caliway announced that the subject recruitment of CBL-514 Phase 2b study for Dercum’s disease has been initiated. The study results are anticipated in Q4 2025.
Caliway announces that the CBL-0204 Phase 2b study was completed successfully at the end of May. The topline results are anticipated in Q4 2024.
Caliway is pleased to announce that Dr. Peter Peng, Chair of the Taiwan Society for Dermatology and Aesthetic Surgery, presents the results of the Phase II clinical trial of CBL-514, the first-in-class candidate drug developed by Caliway, for localized fat reduction at the AMWC Asia-TDAC 2024.
Caliway Completes the Subject Recruitment in CBL-514 Phase 2b Study for Subcutaneous Fat Reduction
Caliway announces the completion of subject recruitment in the CBL-0205 Phase 2b study, enrolling a total of 173 subjects.
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.
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.
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.
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.
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.
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).
Caliway announced that it has closed an oversubscribed capital raise, securing over $100M by issuing 8 million new shares.
CBL-0202 Phase 2 study results met all the primary and secondary endpoints.
Caliway announced the completion of subject recruitment in the CBL-0201EFP Phase 2-stage 2 study.
CBL-0201DD Phase 2 study met the primary and all secondary endpoints.
Caliway announces that the U.S. FDA has approved the company’s IND application for CBL-514 injection’s CBL-0205 Phase 2b Study.
Caliway Has Been Added to S&P Global BMI Index
Caliway Biopharmaceuticals (TPEX: 6919)
The highest dose of CBL-514 treatment demonstrated the best efficacy, 87.5% of thighs achieved at least 1-level improvement in cellulite severity two weeks after CBL-514 treatment.
The study is expected to complete in Q2 2024, and the topline results are anticipated in Q3 2024.
Caliway Has Been Featured In Clinical Trial Arena Pipeline Moves
Clinical Trial Arena: May 2nd Pipeline Moves - Completion of Phase IIa non-malignant disorder trial
The subject recruitment and treatment in CBL-0201EFP Phase 2-Stage 1 is completed.
Caliway Announces Achievements in Revolutionary Fat Reduction Therapy
CBL-514 has demonstrated promising clinical effectiveness and safety in reducing local fat through a mechanism of adipocytes apoptosis.
FDA grants IND approval for phase II for treating rare diseases
CBL-514 injection is suitable for treating rare diseases- Dercum's disease. Applications for U.S. Phase II IND was approved. Upcoming IPO in 2022.
Caliway awarded patents for CBL-514 in the major market countries
CBL-514 has obtained more than 30 patents in major markets, including the United States, Europe, Canada, Australia, Taiwan, South Korea, Singapore, Russia and Mexico, etc.
The phase IIa of CBL-514 injection was completed
Caliway announced the innovative abdominal fat reduction drug CBL-514 to meet primary and secondary endpoints in Phase IIa study.