Denali stock up as it begins rolling BLA submission with the FDA for accelerated approval of tividenofusp alfa for the ...

Key to 400-employee Denali's submission is the FDA allowing measurement of a type of GAG, called heparan sulfate, in ...

for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II) has been received by the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug ...

The lead asset is DNL310, a recombinant, brain penetrating IDS enzyme molecule targeting Hunter syndrome (MPS II), a rare neurodegenerative lysosomal storage disorder. The company is planning a ...

Denali Therapeutics (DNLI) announced that the company’s initiation of a rolling submission of a biologics license application, BLA, for ...

Regenxbio is ranked Strong Buy due to low EV, strong partnerships, royalty income, bullish trends, and buyout potential. Click to read why RGNX is a Strong Buy.

Our teams are planning for potential approval of RGX-121 for MPS II in Q4 2025 and are working ... exciting time for ...