Denali Therapeutics Faces Pipeline Setbacks Despite Avlayah Approval

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Denali Therapeutics has experienced recent pipeline setbacks that may impact its growth prospects, even as its lead drug Avlayah received FDA accelerated approval for Hunter syndrome earlier this year. In May 2026, partner Biogen reported that the mid-stage study of BIIB122 in early-stage Parkinson's disease missed primary and secondary endpoints, leading both companies to discontinue development in idiopathic Parkinson's disease, though Denali will independently continue a phase IIa BEACON study in patients with pathogenic LRRK2 variants, with data expected in the first half of 2027. Additionally, in April 2026, Takeda ended its collaboration on DNL593 for frontotemporal dementia, returning full rights to Denali and shifting the full development and financial burden to the company. Denali's shares have surged 37.9% year to date, and the Zacks Consensus Estimate for 2027 loss per share has narrowed to $2.53 from $2.57 over the past 60 days, with the stock currently carrying a Zacks Rank #3 (Hold).

Impact on stocks 3

Biotech & Genomic Medicine▼ · 3 stocks
Denali Therapeutics Inc
DNLI
▼ NegativeTechnologyrelevance

Pipeline setbacks: BIIB122 failed in Parkinson's and Takeda ended collaboration on DNL593.

Biogen Inc
BIIB
▼ NegativeTechnologyrelevance

Biogen's mid-stage study of BIIB122 in Parkinson's missed endpoints, leading to discontinuation.

Theme Impact 1

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