FDA Grants Orphan Drug Designation to NBM-BMX for Uveal Melanoma

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.”

Share:

More News

“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.