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...
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. - 69.9% and 60.9% of participants lost at least 150mL and 200mL of abdominal subcutaneous fat in the treated area after CBL-514 treatment. - Compared with placebo, an average of 312.1mL of subcutaneous fat was reduced in...
Caliway Announces the Completion of Subject Recruitment in the CBL-0201EFP Phase 2-stage 2 Study Evaluating the CBL-514 in Cellulite Treatment
TAIPEI, Sept. 18, 2023 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway), a biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics, announced the completion of subject recruitment in the CBL-0201EFP Phase 2-stage...
Caliway Announces Positive Data from CBL-0201EFP Phase 2-Stage 1 Study of CBL-514 in Treating Moderate to Severe Cellulite
* CBL-514 is the only non-invasive product that can improve 1-level of cellulite severity two weeks after a single treatment. * 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...
Caliway Biopharmaceuticals Announces Initiation of Subject Recruitment in CBL-0204 Phase 2b Study Evaluating the Efficacy of CBL-514 in Abdominal Subcutaneous Fat Reduction
- Caliway has initiated the subject recruitment in CBL-0204 Phase 2b study. - The study is expected to be completed in Q2 2024, and the topline results are anticipated in Q3 2024. TAIPEI, May 31, 2023 /PRNewswire/ -- Caliway Biopharmaceuticals, a biopharmaceutical company focusing on breakthroug...
