Novelwise Pharmaceutical Receives US FDA Fast Track Designation for NBM-BMX in Metastatic Uveal Melanoma
October 14, 2025
Taipei and San Diego, CA — NovelWise Pharmaceutical Corporation (“NovelWise”) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for NBM-BMX, a selective HDAC8 inhibitor, for the treatment of metastatic uveal melanoma (mUM).
The designation was granted based on preclinical data in uveal melanoma models, as well as safety and dose information from previous Phase I clinical studies. Under the FDA’s Fast Track program, NBM-BMX will be eligible for frequent FDA communications, rolling review, and potential Priority Review if the applicable criteria are met—helping to accelerate both clinical development and regulatory review timelines.
Fast Track Designation is one of the FDA’s expedited pathways designed to encourage the development of new therapies for serious diseases with high unmet medical needs. NovelWise noted that this designation will facilitate more efficient regulatory interactions and clinical planning, helping shorten the time needed to bring new treatment options to patients in need.
Clinical Development Progress
NovelWise plans to initiate site initiation visits (SIVs) by late 2025, followed by a Phase Ib/II clinical trial evaluating NBM-BMX as monotherapy in patients with metastatic uveal melanoma. The study will assess safety, pharmacokinetics (PK), and preliminary antitumor activity, with full protocol details to be posted on ClinicalTrials.gov prior to first-patient-in (FPI).
NBM-BMX is also being evaluated in an ongoing Phase Ib/II glioblastoma (GBM) trial in combination with temozolomide (TMZ). Insights from that program are expected to further optimize the development strategy for metastatic uveal melanoma.
About NBM-BMX
NBM-BMX is a next-generation, selective histone deacetylase 8 (HDAC8) inhibitor designed to modulate epigenetic mechanisms in solid tumors. In uveal melanoma, BAP1-related epigenetic dysregulation is recognized as a key driver of tumor progression.
NBM-BMX remains an investigational compound and has not been approved by the FDA or any other regulatory authority.
About Metastatic Uveal Melanoma (mUM)
Uveal melanoma is the most common primary intraocular malignancy in adults. Approximately half of patients eventually develop metastatic disease—most commonly in the liver. Available treatment options remain limited, and prognosis is poor, highlighting the urgent need for novel mechanisms and accelerated development pathways.
NovelWise stated that the FDA’s Fast Track Designation underscores the therapeutic potential of NBM-BMX and reaffirms the company’s commitment to advancing innovative cancer therapies. The NovelWise team will continue working closely with regulators to advance the program efficiently and responsibly, aiming to bring new treatment options to patients as soon as possible.
Contact:
NWP-US-info.tw@novelwisepharma.com
Disclaimer: 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