CLOUDBREAK-B (02592) surged nearly 8% in the afternoon session, trading at HK$8.6 with a turnover of HK$7.6531 million by the time of writing, marking a 7.5% increase.

The company announced on December 8 that its wholly-owned U.S. subsidiary, Cloudbreak Therapeutics LLC (Cloudbreak USA), scheduled a post-Phase 2 clinical trial meeting with the U.S. Food and Drug Administration (FDA) on December 10, 2025. The meeting will focus on the clinical-stage candidate drug CBT-004.

As disclosed in the prospectus and interim report, CBT-004 is a potential first-in-class ophthalmic drug utilizing a multi-kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) for treating vascularized pterygium.

The group initiated Phase 2 clinical trials for CBT-004 in December 2023 and completed them in May 2025. Results indicated that CBT-004 was safe and well-tolerated in subjects, meeting both primary and several secondary efficacy endpoints. The group finalized the clinical trial report in July 2025 and planned the post-Phase 2 meeting with the FDA.

This meeting represents a critical milestone in CBT-004's development, aiming to discuss potential Phase 3 clinical trials and new drug application requirements. The company will provide further updates to ensure shareholders and potential investors stay informed about the latest progress.