Novelwise Pharmaceutical Corporation

FDA Grants Fast Track and Orphan Drug Designations to NBM-BMX for Metastatic Uveal Melanoma

- The FDA has granted both Fast Track and Orphan Drug Designation to NBM-BMX, a selective HDAC8 inhibitor developed by NovelWise Pharmaceutical Corporation for treating metastatic uveal melanoma. - NBM-BMX targets BAP1-associated epigenetic dysregulation in uveal melanoma and has demonstrated safety in prior phase 1 studies with advanced solid tumors. - The Orphan Drug Designation provides seven years of market exclusivity, waiver of FDA filing fees, and 25% federal tax credit on clinical trial expenses. - A phase 1/2 clinical trial is underway at ten leading U.S. cancer centers to evaluate NBM-BMX's safety, efficacy, and pharmacokinetics in metastatic uveal melanoma patients.