Denali Therapeutics Reports Third Quarter 2026 Financial Results and Business Highlights
Globe Newswire•03/11/2026•16:01 ET
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Key Highlights
- ➤AVLAYAH Q3 net product revenue reached $17.8 million in its second full commercial quarter
- ➤Q4 2026 net product revenue guidance set at $30.0 million to $32.0 million
- ➤U.S. commercial coverage exceeded 70% of lives, up from more than 50%
- ➤Zafinofusp alfa BLA submission remains on track for 2027 accelerated approval
- ➤Q3 net income $70.1 million included a one-time $194.0 million voucher-sale gain
Expert Statements
Ryan Watts, Chief Executive Officer of Denali Therapeutics
“Families and physicians are telling us that AVLAYAH is making a difference for children with Hunter syndrome, and the results this quarter reflect that”
Ryan Watts, Chief Executive Officer of Denali Therapeutics
“The positive responses to AVLAYAH across patients, physicians and payers, and our team’s strong commercial execution, show what is possible for our TransportVehicle portfolio.”
Ryan Watts, Chief Executive Officer of Denali Therapeutics
“We are applying what we have learned from developing and launching AVLAYAH as we work with urgency to bring zafinofusp alfa to families affected by Sanfilippo syndrome type A, who need treatment options designed to address disease in the brain and body.”
Ryan Watts, Chief Executive Officer of Denali Therapeutics
“We look forward to sharing the Phase 1/2 data, which will support a BLA submission in 2027 as planned.”
Ryan Watts, Chief Executive Officer of Denali Therapeutics
“Next year we also expect data from our TransportVehicle programs in Alzheimer’s disease, FTD-GRN and Pompe disease as we build on this momentum across our pipeline of blood-brain barrier therapeutics.”
* AVLAYAH® (tividenofusp alfa-eknm) net product revenue accelerated to $17.8 million in its second full commercial quarter
* Continued growth expectations drive Q4 2026 net product revenue guidance of $30.0 million to $32.0 million
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