Caliway Biopharmaceuticals C, TW0006919004

Caliway Biopharmaceuticals stock advances as Phase 3 expands

Published on 11/05/2026 at 11:01 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Caliway Biopharmaceuticals stock enters a new clinical phase as SUPREME-02 enrollment begins. A second study continues in Asia-Pacific.

Clinical program moves into next phase

SUPREME-02 is designed to expand Caliway's global clinical evidence for CBL-514.
CBL-0206 continues enrollment in Taiwan and Australia for the Asia-Pacific program.
Preclinical combination data are scheduled for presentation at ObesityWeek on November 15.

Caliway Biopharmaceuticals C, TW0006919004, Illustration mit AI erstellt.

Caliway Biopharmaceuticals said on October 29 that enrollment had begun in SUPREME-02, its second global pivotal Phase 3 trial for investigational drug candidate CBL-514. The announcement expands the company's late-stage development program for abdominal subcutaneous fat reduction.

Second pivotal trial begins enrollment

According to a Caliway Biopharmaceuticals release, SUPREME-02 is a randomized, double-blind and placebo-controlled multinational study. The trial is expected to enroll approximately 320 participants at 30 to 35 sites in the United States and Canada.

The study will evaluate the efficacy, safety and tolerability of CBL-514 in reducing abdominal subcutaneous fat. Patient and clinician assessments will be supplemented by imaging measures, including magnetic resonance imaging. Caliway said SUPREME-02 will complement the ongoing SUPREME-01 trial and help build evidence for potential future regulatory submissions.

Asia-Pacific program also advances

Alongside the global Phase 3 program, Caliway continues enrollment in the Phase 2 CBL-0206 study in Taiwan and Australia. The company said the regional trial is intended to broaden clinical data in Asian populations and support future regulatory, commercial and partnering plans.

For investors, the enrollment milestone extends Caliway's clinical timetable but does not provide efficacy or safety results from SUPREME-02. CBL-514 remains an investigational drug candidate, so the next major development risk lies in recruitment, trial execution and the eventual clinical readout.

Combination data due in November

Caliway plans to present preclinical combination-therapy findings at ObesityWeek 2026 in Washington, D.C., on November 15. The presentation will examine CBL-514 with semaglutide and eloralintide, focusing on weight reduction and the mitigation of weight regain after treatment discontinuation. These findings are preclinical and do not establish clinical benefit in humans.