Denali's AVLAYAH revenue climbs to $17.8 million as zafinofusp alfa BLA stays on track for 2027

Denali Therapeutics reported financial results for the third quarter ended September 30, 2026 on November 3, 2026. AVLAYAH net product revenue accelerated to $17.8 million in its second full commercial quarter, with Q4 2026 net product revenue guidance set at $30.0 million to $32.0 million.¹

AVLAYAH's U.S. launch gained momentum, with commercial coverage now exceeding 70% of U.S. lives, up from more than 50% in the prior quarter, 20 state Medicaid programs publishing coverage, and a permanent J-code becoming effective October 1, 2026.¹ Denali also completed enrollment of Cohort B in the global Phase 2/3 COMPASS study, for a total of 65 participants across Cohorts A and B, with data expected in the first half of 2028.¹

On the pipeline, the Phase 1/2 study of zafinofusp alfa completed the prespecified treatment duration for its primary endpoint after enrolling 20 participants across the pediatric age range, with a BLA submission in 2027 seeking accelerated approval still on track.¹ Enrollment in the Phase 1/2 study of DNL593 for FTD-GRN is complete with 40 participants, and data are expected in the first half of 2027.¹ The Phase 2a BEACON study of DNL151 in LRRK2-positive Parkinson's disease is ongoing, with data expected in the first half of 2027.¹

On financials, net income was $70.1 million for the quarter, compared to a net loss of $126.9 million a year earlier, including a one-time $194.0 million net gain on the sale of a Priority Review Voucher.¹ Cash, cash equivalents and marketable securities totaled approximately $1.0 billion as of September 30, 2026.¹