Quarterly ResultMay 7, 2026, 04:10 PM
Denali's AVLAYAH FDA Approved & Launched; Q1 Net Loss $128.4M
AI Summary
Denali Therapeutics announced the FDA approval and U.S. commercial launch of AVLAYAH™ (tividenofusp alfa-eknm) for Hunter syndrome, marking the first medicine to leverage the transferrin receptor to cross the blood-brain barrier. The company reported a Q1 2026 net loss of $128.4 million, an improvement from $133.0 million in Q1 2025. Denali also highlighted progress in its clinical pipeline, including dosing the first patient with OTV-enabled DNL628 for Alzheimer's disease and advancing DNL593 for FTD-GRN after regaining full rights from Takeda.
Key Highlights
- FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for Hunter syndrome on March 25, 2026.
- AVLAYAH™ launched in the U.S. with first patients treated commercially in April.
- Net loss for Q1 2026 was $128.4 million, an improvement from $133.0 million in Q1 2025.
- Research and development expenses decreased to $103.8 million from $116.2 million year-over-year.
- General and administrative expenses increased to $33.5 million from $29.4 million year-over-year.
- First patient dosed with OTV-enabled DNL628 for Alzheimer's disease in March 2026.
- Regained full rights to DNL593 for FTD-GRN after Takeda terminated collaboration.
- Cash, cash equivalents, and marketable securities totaled $1.05 billion as of March 31, 2026.