In 2021, the FDA granted Fast Track designation to tividenofusp alfa for the treatment of patients with Hunter syndrome. In 2022, the European Medicines Agency granted Priority Medicines ...

With an FDA approval submission for RegenXBio’s Hunter syndrome gene therapy already underway, the biopharma has now ...

Hunter syndrome results from the absence of an enzyme needed to break down cellular waste. Without it, waste builds up in the body, causing progressive damage to various systems.

Hunter syndrome can be diagnosed using the physical symptoms of children at the age of 18 months and 4 years. Treatments can help manage condition, no known cure Diagnosed by medical professional ...

That's because it recently received FDA Breakthrough Therapy Designation [BTD] for tividenofusp alfa [DNL310] for the treatment of patients with Hunter Syndrome [also known as MPS II]. Even better ...

Japan’s Nippon Shinyaku is continuing to scoop up the international rights to some intriguing drugs, this time penning a $686 ...

Nippon Shinyaku will pay Regenxbio $110 million upfront for U.S. and Asia rights to treatments for Hunter and Hurler syndromes.

Jeffrey Hung, an analyst from Morgan Stanley, maintained the Buy rating on Denali Therapeutics (DNLI – Research Report). The associated price ...

In a deal potentially worth $810 million for Regenxbio Inc., Nippon Shinyaku Co. Ltd. is partnering on the U.S. and Asian development and commercialization of iduronate-2-sulfatase enzyme RGX-121 for ...

Despite having gone through this before with her first son, Yusof, and despite the doctors explaining that this was a gene ...

Detailed price information for Denali Therapeutics Inc (DNLI-Q) from The Globe and Mail including charting and trades.

Regenxbio (RGNX) and Nippon Shinyaku announced a strategic partnership for the development and commercialization of RGX-121 for the treatment ...