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11
2026
2026.11.06 -
Caliway's CBL-514 Receives Early IND Clearance in China, Accelerating Development in the World's Fastest-Growing Body Contouring Market
announced that its China clinical trial (CBL-0102) for CBL-514, the Company's first-in-class injectable drug candidate for large-area localized fat reduction, has officially received authorization to proceed from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The program was independently developed and submitted by the Company, an achievement rarely accomplished by Taiwan biotechnology companies. Moreover, the earlier-than-expected regulatory clearance not only reflects regulatory confidence in the study design, but also accelerates the Company's clinical development strategy in China.
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10
2026
2026.10.30 -
Caliway Biopharmaceuticals Clarifies Unauthorized Online Claims Regarding CBL-514
The Company has recently identified information on certain online platforms and third-party websites claiming to offer, supply, market, or sell products related to CBL-514, the Company's investigational drug candidate currently under development. Such information may create confusion among investors, healthcare professionals, and the general public. The Company therefore issues the following clarification:
CBL-514 remains an investigational drug candidate in clinical development and has not received marketing approval in any country or jurisdiction. It is not commercially available in any market. The Company has not authorized any third party to supply, distribute, market, or sell CBL-514, nor has it authorized any third party to act on its behalf or imply any affiliation, partnership, licensing, agency, distribution, or other relationship with the Company. Any claim regarding the availability or sale of CBL-514 is unauthorized and is not associated with the Company. -
10
2026
2026.10.29 -
Caliway Advances Dual Global Phase 3 Program as SUPREME-02 Enrollment Begins
Caliway announced the initiation of enrollment in SUPREME-02 (CBL-0302), the Company's second global, multicenter Phase 3 pivotal trial evaluating CBL-514, its first-in-class investigational drug for the reduction of abdominal subcutaneous fat. The launch of SUPREME-02 marks another key milestone in Caliway's global development program and will complement the ongoing SUPREME-01 (CBL-0301) study. Together, the two pivotal Phase 3 trials are expected to generate the clinical evidence required to support future regulatory submissions for CBL-514.
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10
2026
2026.10.02 -
EASD Press Room Features New Data on CBL-514 for Reducing Subcutaneous and Visceral Fat
Studies show that the new drug, CBL-514, reduces levels of subcutaneous and visceral fat. The data also suggest that it helps attenuate weight regain on stopping GLP-1 receptor agonist drugs (GLP1-RAs), says Dr W. Timothy Garvey, of the University of Alabama at Birmingham, Birmingham, USA.
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09
2026
2026.09.23 -
Caliway Announces First Patient Dosed in Global Phase 3 SUPREME-01 Trial of CBL-514; New Preclinical Data Accepted for Presentation at ObesityWeek 2026
Caliway announced that SUPREME-01 (CBL-0301), its global pivotal Phase 3 clinical trial evaluating CBL-514 for large-area abdominal fat reduction, has successfully dosed its first participant (First Patient In, FPI). The trial has now formally entered the treatment phase and continues to enroll participants across North America.
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09
2026
2026.09.21 -
Caliway Announces Positive Phase 2 Results of CBL-514 in Dercum's Disease, Achieving Primary Endpoint with Statistically Significant and Sustained Pain Reduction
Caliway announced final statistical results from its randomized, single-blind, placebo-controlled Phase 2 clinical trial (CBL-0202DD) evaluating CBL-514 for the treatment of Dercum’s Disease (DD), a rare and debilitating disorder characterized by painful lipomas. The study successfully achieved its primary efficacy endpoint, with CBL-514 demonstrating clinically meaningful and statistically significant pain reduction in both the Full Analysis Set (FAS) and Per-Protocol (PP) populations. The results showed robust and durable efficacy, with treatment benefits consistently observed across multiple assessment time points and increasing over all treatment courses.
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08
2026
2026.08.31 -
Caliway Biopharmaceuticals Highlights Global Phase 3 Progress and GLP-1 Combination Strategy at 2026 Second-Half Online Investor Conference
Caliway hosted its 2026 Second-Half Online Investor Conference, highlighting the significant momentum of its global pivotal Phase 3 program for CBL-514. The Company also detailed the strategic expansion of its GLP-1 combination program and the steady progression of its international clinical development pipeline.
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08
2026
2026.08.25 -
Caliway's CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment
Caliway announced two major clinical milestones in its new drug development program. The Investigational New Drug application for CBL-0201WR, a Phase 2 clinical trial combining its first-in-class local fat-reducing new drug CBL-514 with Eli Lilly's Zepbound® (Tirzepatide), has been cleared by the U.S. FDA. In addition, the pivotal Phase 3 clinical trial SUPREME-01, evaluating large-area abdominal fat reduction, has received approval from the IRB and has officially initiated enrollment.
