Denali Therapeutics (DNLI +17.5%) announces positive early-stage data on lead candidate DNL201 in Parkinson’s disease (PD) as part of its pipeline update. Highlights:
DNL201: Phase 1b data met all biomarker goals for both doses tested while being generally well-tolerated at the lower dose. At the higher dose, most subjects experienced mild or moderate adverse events (AEs). One participant experienced a severe AE (headache) that led to dose reduction and there was one discontinuation (headache and nausea). All treatment-emergent AEs were manageable and reversible.
DNL151: Phase 1 results in healthy volunteers met all safety and biomarker goals.
The company will select either DNL201 or DNL151 to advance into Phase 2/3 for PD.
DNL310: IND filed in U.S. for Hunter syndrome (mucopolysaccharidosis type II). Assuming FDA sign-off, a Phase 1/2 study is next up.
DNL343: A Phase 1 study in healthy volunteers should launch soon.
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