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NEW TAIPEI CITY - Caliway Biopharmaceuticals (TWSE:6919) will be added to the Taiwan component of the MSCI Global Standard Index effective August 26, 2025, the company announced Tuesday.
The upgrade from the MSCI Global Small Cap Index reflects the company’s market capitalization, liquidity, and financial transparency, potentially increasing investment from international passive and index-tracking funds.
Simultaneously, Caliway reported that Health Canada has approved its global pivotal Phase 3 study SUPREME-01 for CBL-514, an injectable drug candidate for site-specific fat reduction. The study previously received U.S. FDA clearance and is expected to begin recruitment in the third quarter of 2025 across 29 clinical sites in the U.S. and Canada.
The randomized, double-blind, placebo-controlled study will enroll 300 participants to evaluate CBL-514’s efficacy in reducing abdominal subcutaneous fat. The primary endpoints include abdominal fat volume change measured by MRI and patient-reported assessments.
CBL-514 is being developed as a 505(b)(1) investigational drug for the proposed indication of "Reduction of Abdominal Subcutaneous Fat." According to the company, it works by inducing adipocyte apoptosis to reduce fat in targeted areas without causing systemic side effects.
"Being included in the MSCI Global Standard Index is a strong recognition by the international capital market of our fundamentals," said CEO Vivian Ling in the press release statement.
The company has completed 10 clinical trials involving 520 subjects for CBL-514 as of May 2025, with additional indications under investigation including cellulite treatment and weight management.
In other recent news, Caliway Biopharmaceuticals announced that the U.S. Food and Drug Administration has cleared its investigational drug CBL-514 to proceed with a pivotal Phase 3 clinical trial. This trial, named SUPREME-01, focuses on the reduction of abdominal subcutaneous fat. The clearance marks a significant step for CBL-514, as it is the first 505(b)(1) investigational drug to receive FDA clearance for Phase 3 trials specifically for fat reduction rather than aesthetic improvement. This development highlights Caliway’s progress in advancing its clinical pipeline. The company’s focus on fat reduction sets it apart from more common aesthetic indications. Investors and stakeholders will be closely watching the outcomes of this trial.
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