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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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

Backed by International Authority — Caliway's latest preclinical data on its proprietary localized fat reduction candidate, CBL-514, in combination with GLP–1R–based weight–loss therapies, were presented at the American Diabetes Association 2026 Scientific Sessions (ADA 2026). The findings were delivered by Timothy Garvey, MD, an internationally renowned expert in obesity and metabolic medicine and a scientific advisor to Caliway, garnering significant interest from global experts and multinational pharmaceutical companies.

Attenuation of Post–Discontinuation Weight Regain — The newly disclosed OI25 animal study confirmed that CBL–514 combined with GLP–1R–based therapies achieved superior weight loss compared to monotherapy. Following treatment cessation,

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

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 Rega

Thu, 11 Jun 2026 00:54:00 -0400

Caliway receives FDA clearance for second phase 3 trial of fat reduction drug

Fri, 22 May 2026 03:09:59 -0400

Caliway Biopharmaceuticals (TWSE: 6919) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for CBL-0302, the company's second pivotal phase 3 study of CBL-514, a drug candidate for abdominal subcutaneous fat reduction.

The IND application passed the FDA's 30-day review period on May 18. CBL-0302 is designed as a randomized, double-blind, placebo-controlled study expected to enroll approximately 320 participants across the United States, Canada, and Australia.

Caliway plans to initiate both of its global pivotal phase 3 studies, CBL-0301 and CBL-0302, in the near term, with clinical results anticipated in 2027. The company has submitted clinical

Caliway receives FDA clearance for second phase 3 trial of fat reduction drug

Fri, 22 May 2026 03:09:59 -0400

Caliway plans to initiate both of its global pivotal phase 3 studies, CBL-0301 and CBL-0302, in the near term, with clinical results anticipated in 2027. The company has submitted clinical

Caliway receives FDA clearance for second phase 3 trial of fat reduction drug

Fri, 22 May 2026 03:09:59 -0400

Caliway plans to initiate both of its global pivotal phase 3 studies, CBL-0301 and CBL-0302, in the near term, with clinical results anticipated in 2027. The company has submitted clinical

Caliway receives FDA clearance for second phase 3 trial of fat reduction drug

Fri, 22 May 2026 03:09:59 -0400

Caliway plans to initiate both of its global pivotal phase 3 studies, CBL-0301 and CBL-0302, in the near term, with clinical results anticipated in 2027. The company has submitted clinical

Caliway receives FDA clearance for second phase 3 trial of fat reduction drug

Fri, 22 May 2026 03:09:59 -0400

Caliway plans to initiate both of its global pivotal phase 3 studies, CBL-0301 and CBL-0302, in the near term, with clinical results anticipated in 2027. The company has submitted clinical

Caliway receives FDA clearance for second phase 3 trial of fat reduction drug

Fri, 22 May 2026 03:09:59 -0400

Caliway plans to initiate both of its global pivotal phase 3 studies, CBL-0301 and CBL-0302, in the near term, with clinical results anticipated in 2027. The company has submitted clinical

Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514

Fri, 22 May 2026 03:09:00 -0400

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy

U.S. FDA Clearance: 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.
Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC

Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514

Fri, 22 May 2026 03:09:00 -0400

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy

U.S. FDA Clearance: 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.
Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC

Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514

Fri, 22 May 2026 03:09:00 -0400

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy

U.S. FDA Clearance: 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.
Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC

Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514

Fri, 22 May 2026 03:09:00 -0400

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy

U.S. FDA Clearance: 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.
Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC

Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514

Fri, 22 May 2026 03:09:00 -0400

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy

U.S. FDA Clearance: 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.
Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC

Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514

Fri, 22 May 2026 03:09:00 -0400

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy

U.S. FDA Clearance: 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.
Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC

Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514

Fri, 22 May 2026 03:09:00 -0400

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy

U.S. FDA Clearance: 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.
Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC