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...
