Novelwise Pharma Secures FDA Clearance to Launch Phase Ib/II Trial of NBM-BMX in Metastatic Uveal Melanoma

Novelwise Pharmaceutical Corporation announced that the U.S. Food and Drug Administration (FDA) has approved its investigational drug NBM-BMX to proceed with a Phase Ib/II clinical trial in metastatic uveal melanoma (mUM). The company submitted its IND on June 30, 2025, and the trial is set to begin in October 2025, marking a significant milestone in the program's progress.

Metastatic uveal melanoma is a rare and aggressive cancer with no currently available effective treatments. NBM-BMX is designed to address this urgent unmet medical need, providing a new therapeutic option for patients. The company also plans to seek Orphan Drug Designation to accelerate development and enhance future commercialization prospects.

With this milestone, Novelwise Pharma is strengthening its oncology pipeline, expanding international collaborations, and promoting clinical innovation to create sustainable value for patients, investors, and partners.