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

Denali’s wholly owned program, DNL310 or tividenofusp alfa, is an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome).

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 ...

Shire’s attempts to develop a drug for cognitive impairment from the rare inherited disease Hunter Syndrome has failed ... and families living with MPS II.” “We are grateful to the children ...

The UK regulatory authorities have approved the first ever trial of a revolutionary gene therapy for young children diagnosed with Hunter syndrome ... also known as mucopolysaccharidosis type II (MPS ...

The University of Manchester has announced today a groundbreaking gene therapy partnership to ease the lifelong suffering of people with Hunter syndrome. The University has agreed to a worldwide ...

MPS II (Hunter Syndrome), MPS IV (Morquio Syndrome), and Osteogenesis Imperfecta preventive oral health services to complement the PhilHealth Konsulta package improved coverage for Peritoneal ...

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