Denali reports first full AVLAYAH quarter, advances Alzheimer's pipeline, sells PRV for $195 million

Denali Therapeutics reported second quarter 2026 results on August 6, 2026, covering the period ended June 30, 2026.

AVLAYAH (tividenofusp alfa-eknm), approved in March 2026 for neurologic manifestations of Hunter syndrome, had its first full quarter of commercial availability, generating $3.6 million in net product revenue.¹ The company projected third-quarter 2026 net product revenue of $10.0 million to $12.0 million.¹ Denali said roughly 80% of healthcare organizations treating eligible MPS II patients have been reached through launch webinars and field team engagement,¹ and that published commercial policies now cover more than half of covered lives, with 14 state Medicaid programs having published coverage.¹

On the pipeline, Denali said it expects to submit a BLA and seek potential accelerated approval for zafinofusp alfa in Sanfilippo syndrome type A in 2027,¹ with start-up activities underway for a global Phase 3 confirmatory study.¹ For DNL593 in FTD-GRN, enrollment in the Phase 1/2 study is complete with 40 participants, and Denali now expects results in 2027, pushed back from its prior end-of-2026 target,¹ to allow more time to observe biomarker changes. Separately, the FDA granted Orphan Drug Designation to DNL593 for FTD-GRN in August 2026.¹ Dosing began in the Phase 1 study of DNL952 for Pompe disease during the quarter, with initial clinical data expected in 2027.¹ Two Alzheimer's programs, DNL628 and DNL921, remain in early clinical stages, with initial biomarker data from DNL628 expected in the first half of 2027¹ and safety and proof-of-concept data from DNL921 expected in 2027.¹

In Parkinson's disease, the Phase 2b LUMA study of DNL151 did not meet its primary or secondary endpoints, and Denali and partner Biogen discontinued development in idiopathic Parkinson's disease,¹ though the Phase 2a BEACON study in LRRK2 variant carriers continues, with data expected in the first half of 2027. Takeda also terminated its DNL593 collaboration in April 2026, a decision Denali said was driven by strategic considerations and not related to efficacy or safety data.¹

On cash, Denali reported approximately $940.0 million in cash, equivalents and marketable securities as of June 30, 2026, rising to more than $1.1 billion on a pro forma basis after $195.0 million in gross proceeds from a Priority Review Voucher sale that closed in July 2026.¹