Novelwise Pharmaceuticals Announces FDA “May Proceed” Clearance for Phase Ib/II Trial of NBM-BMX in Metastatic Uveal Melanoma

Taipei, July 30, 2025 —— Novelwise Pharmaceuticals today announced that its investigational cancer therapy NBM-BMX has been deemed safe to proceed by the United States Food and Drug Administration (US FDA). The company has received the official Study May Proceed letter, authorizing the initiation of a Phase Ib/II multicenter clinical trial in the United States for patients with metastatic uveal melanoma (mUM). The study will evaluate the safety, efficacy, and pharmacokinetics of NBM-BMX in this rare cancer population.

Metastatic uveal melanoma is a rare disease with no approved effective therapies. NBM-BMX, a small-molecule specific HDAC8 inhibitor, has been designed for this indication and, if successful, could significantly improve treatment options for patients worldwide. Novelwise also plans to pursue Orphan Drug Designation, subsequent clinical development, and eventual New Drug Application (NDA).

According to the April 2025 report from Smart Insights Market Research, the global market for uveal melanoma therapies was valued at USD 650 million in 2022 and is projected to reach USD 1.25 billion by 2030, representing a compound annual growth rate (CAGR) of 8.5%. With the advancement of clinical studies and potential regulatory advantages, NBM-BMX may represent a significant value driver for the company.

The company cautions that drug discovery and development is a long, costly, and high-risk process with no guarantee of success. Investors are advised to exercise prudent judgment and make careful investment decisions.