FDA Grants Orphan Drug Designation to NBM-BMX for Uveal Melanoma
SAN DIEGO, CA, UNITED STATES — November 23, 2025 — NovelWise Pharmaceutical Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its selective HDAC8 inhibitor, NBM-BMX, for the treatment of uveal melanoma (UM).
This designation follows the recent Fast Track status and further accelerates the development of NBM-BMX.
NBM-BMX is a next-generation HDAC8-selective inhibitor designed to modulate tumor DNA repair and survival pathways, with the potential to delay resistance and improve clinical outcomes in patients with this aggressive rare cancer.
Key Benefits of Orphan Drug Designation
- 7 years of U.S. market exclusivity upon approval (independent of patents)
- Waiver of FDA PDUFA filing fee
- 25% federal tax credit on U.S. clinical trial expenses
- Enhanced FDA regulatory guidance and more frequent scientific interactions
- Eligibility for Accelerated Approval and Rolling Review, strengthened by existing Fast Track status
Advancing Clinical Development Across the United States
NovelWise is conducting its ongoing clinical program in collaboration with ten leading cancer centers across the U.S.
Three sites have completed Site Initiation Visits (SIVs), and the study is progressing toward expanded activation and enrollment.
John Soong, MD, Chief Executive Officer of NovelWise, commented:
“Receiving both Fast Track Designation and now Orphan Drug Designation underscores NBM-BMX’s promise in addressing a high unmet medical need for patients with uveal melanoma. These regulatory milestones will accelerate the development pathway for NBM-BMX and support our mission of delivering innovative therapy options to patients suffering from rare and aggressive cancers.”
Contact:
NWP-US-info.tw@novelwisepharma.comDisclaimer: NBM-BMX is an investigational drug that has not been approved for marketing in any country or region. Development timelines and plans are subject to change based on clinical and regulatory progress.
Media & Investor Contact
Annie Pai
Project Leader / Director of Clinical Operations
NovelWise Pharmaceutical Corporation USA
annie.pai@novelwisepharma.com | +1 (910) 297-9045