Over 49 weeks of DNL310 (ETV:IDS) treatment in the Phase 1/2 study, positive changes across measures of exploratory clinical outcomes including VABS-II (adaptive behavior) and BSID-III (cognitive ...

Interim results demonstrate average reduction of 64% (p <0.001) from baseline in serum NfL after 2 years of dosing with DNL310 in Phase 1/2 study FDA has recommended assessment of NfL, a marker of ...

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to ...

Regenxbio Inc., a leading clinical-stage biotechnology company, announced positive results from the phase I/II/III CAMPSIITE trial of RGX-121 for the treatment of patients with Mucopolysaccharidosis ...

Long-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in hearing, cognition and adaptive behavior ...

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The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for tividenofusp alfa for the treatment of Hunter syndrome, also known as ...

All but one participant has neuronopathic MPS II, and the median age at enrollment was 5 years (range 2 to 12). Participants received weekly intravenous doses of DNL310 starting on day 1 of the study, ...

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All but one participant has neuronopathic MPS II, and the median age at enrollment was 5 years (range 2 to 12). Participants received weekly intravenous doses of DNL310 starting on day 1 of the study, ...