BioCentury
ARTICLE | Product Development

July 26 Quick Takes: Denali dips on Hunter syndrome readout

Plus: GSK, BMS, PerkinElmer-BioLegend and more

July 27, 2021 2:09 AM UTC

Denali Therapeutics Inc. (NASDAQ:DNLI) shed 15% to $54.14 Monday, losing about $1.2 billion in market cap, after reporting interim data from a Phase I/II trial of ETV:IDS (DNL310) showing that patients with Hunter syndrome receiving the brain-penetrant enzyme replacement therapy had increases in serum neurofilament levels, rather than reductions; those patients typically have elevated levels of the exploratory biomarker. Despite the lack of clarity, Denali plans to start a pivotal Phase II/III study of the candidate in 1H22. 

An expanded label for Shingrix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to include immunocompromised adults gives the shingles vaccine another avenue for growth. First approved by FDA in 2017 to prevent shingles in adults ages 50 and up, the vaccine had 2020 sales of £2 billion ($2.7 billion). That’s up 11% at a constant exchange rate, with growth driven by a strong performance in Europe and a launch in China...