Cloudbreak Pharma Inc. (CLOUDBREAK-B) reported that the U.S. Food and Drug Administration completed its safety review of the investigational new drug (IND) application for CBT-358 on 14 July 2026 with no objections, allowing the proposed clinical investigation to proceed.

The IND for CBT-358—a combination of Semi-fluorinated Alkane (SFA+) and a transient receptor potential melastatin 8 (TRPM8) agonist—was originally submitted on 21 May 2026. According to prior company disclosures, the therapy is designed to treat dry eye disease caused by insufficient tear production and aims to improve patient comfort in a global market characterized as “multi-billion dollar” in scale.

Management described the FDA’s green light as a “critical milestone” in CBT-358’s clinical development and confirmed that the Group will continue to monitor subsequent evaluation stages. The company reiterated that there is no assurance the candidate, or any other in its pipeline, will ultimately achieve successful development, launch or commercialization.

Investors are advised to exercise caution when dealing in the company’s shares, as stated in the voluntary announcement dated 17 July 2026.