Denali Therapeutics Q2 2026 Results: AVLAYAH Launch Progress and Pipeline Updates

Denali Therapeutics reported second quarter 2026 financial results, highlighted by the first full quarter of sales for AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome, which generated $3.6 million in net product revenue. The company projected Q3 2026 AVLAYAH revenue between $10.0 million and $12.0 million. In July 2026, Denali received $195 million from the sale of a Priority Review Voucher, bringing its pro forma cash position to over $1.1 billion. Clinical updates include the expected BLA submission for zafinofusp alfa (MPS IIIA) in 2027. However, the company revised the timeline for DNL593 (FTD-GRN) results to 2027 (previously late 2026) to allow for longer biomarker observation. Additionally, Takeda terminated its collaboration on DNL593 for strategic reasons. Following the failure of the Phase 2b LUMA study, Denali and Biogen discontinued DNL151 in idiopathic Parkinson’s disease, though Denali continues the BEACON study in LRRK2 carriers. Net loss for the quarter was $127.6 million.