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08
2026
2026.08.03 -
Caliway Initiates CBL-514 Clinical Development in China to Maximize Global Licensing Value in the World's Second-Largest Aesthetics Market
Caliway announced that it has submitted an IND application to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the Phase 1 clinical study (CBL-0102) of its first-in-class, large-area localized fat reduction drug candidate, CBL-514. This submission marks the formal debut of the candidate's clinical development program in China.
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07
2026
2026.07.28 -
Caliway Targets First-in-Class FDA "2-Grade Improvement" Claim with Upgraded CBL-514 Phase 3 Trial Enrolling in August
Caliway announced that it has submitted trial design amendments for its first-in-class, large-volume, local fat-reducing new drug, CBL-514. The amendments for the pivotal Phase 3 clinical trial, CBL-0301 (SUPREME-01), have been filed with the U.S. FDA as an IND amendment and with Health Canada as a Clinical Trial Application (CTA) amendment, in accordance with FDA recommendations. The trial protocol is concurrently under review by central Institutional Review Boards (IRBs) in the U.S. and Canada, with the first patient expected to be enrolled in August upon IRB approval.
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07
2026
2026.07.27 -
Targeting the Pain Point of Weight Regain in GLP-1 Receptor Agonists: Caliway Submits Phase 2 IND to US FDA for CBL-514 Combination Therapy; Clinical Data on Visceral Fat Reduction Selected for Oral Presentation at the EASD 2026 Annual Meeting
Caliway announced the submission of an Investigational New Drug (IND) application to the U.S. FDA for CBL-0201WR. This randomized, placebo-controlled, multicenter Phase 2 clinical study will evaluate the company's novel fat-reducing candidate, CBL-514 injection, in combination with Zepbound® (tirzepatide, Eli Lilly). Also, CBL-514’s clinical data on visceral fat reduction has been selected for an oral presentation at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting.
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07
2026
2026.07.03 -
Caliway’s CBL-514 Follow-Up Study CBL-0303 Allowed by U.S. FDA to Proceed Following Completion of 30-Day IND Review; CBL-0206 Begins Subject Enrollment in Australia
Caliway announced that the U.S. FDA has completed the 30-day review period for the Investigational New Drug (IND) application of CBL-0303, a follow-up clinical study of CBL-514 for abdominal subcutaneous fat reduction. The Company will proceed with study initiation as planned. In addition, the Asia-Pacific Phase 2 clinical trial CBL-0206 has initiated subject enrollment in Australia, further expanding safety and efficacy data in an Asian population.
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06
2026
2026.06.24 -
Clarifying False Online Information
The Company has recently become aware that the website of RCPFARMA contains false statements purporting a partnership with the Company, which may mislead investors and the public.
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06
2026
2026.06.10 -
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
Caliway presented new OI25 preclinical data at ADA 2026 demonstrating that CBL-514, in combination with GLP-1R-based weight-loss therapies, enhanced weight-loss durability, attenuated post-discontinuation weight regain, and improved metabolic outcomes.
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06
2026
2026.06.08 -
Caliway Announces IND Submission to U.S. FDA for CBL-514 Long-Term Follow-Up Phase 3 Trial (CBL-0303)
Seamlessly Extension Twin Pivotal Phase 3 Studies to Support NDA Pathway and Target the Global Broad-Area Non-Surgical Local Fat Reduction Market
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05
2026
2026.05.22 -
Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514; Asia-Pacific Phase 2 Study CBL-0206 Also Approved by AU HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy
The Investigational New Drug (IND) application for CBL-0302 (SUPREME-02), Caliway’s second multi-country pivotal Phase 3 study for its localized fat reduction candidate CBL-514, has successfully passed the FDA's 30-day review period.
