Denali Therapeutics reported third-quarter net product revenue of $17.8 million from AVLAYAH, its Hunter syndrome treatment. That beat August guidance of $10 million to $12 million, and the company expects $30 million to $32 million in the fourth quarter. Commercial coverage rose to more than 70% of covered lives from more than 50%. Denali warned that the sharp quarterly increase is not a continuing run rate. The company plans to seek accelerated approval in 2027 for zafinofusp alfa in Sanfilippo syndrome type A. Full results from 20 participants are due in the first quarter of 2027. Net income was $70.1 million, largely from $195 million in proceeds from selling a priority review voucher. Denali ended September with about $1.01 billion in cash and marketable securities.

Denali Therapeutics beat third-quarter earnings expectations, and its shares rose 9.8% in after-hours trading on Tuesday. Sales of its newly launched drug AVLAYAH drove the result. Revenue was $17.77 million, against an estimate of $12.22 million. Net income was $70.1 million, including a one-time $194.0 million net gain from selling a Priority Review Voucher. Adjusted earnings per share were $0.37, against a consensus of -$0.37. AVLAYAH treats neurologic symptoms of Hunter syndrome. The company expects fourth-quarter net product revenue of $30.0 million to $32.0 million. Denali plans to submit a Biologics License Application in 2027 for its second candidate, zafinofusp alfa, for Sanfilippo syndrome type A. It held about $1.0 billion in cash and securities as of September 30, 2026.

Denali Therapeutics soars on earnings beat. Investing.com - Denali Therapeutics Inc (NASDAQ:DNLI) reported third-quarter earnings that exceeded analyst expectations, driven by accelerating sales of its recently launched product AVLAYAH, sending shares up 9.8% in after-hours trading Tuesday. The company posted adjusted earnings per share of $0.37, beating the analyst consensus of -$0.37 by $0.74. Revenue reached $17.77 million, surpassing the $12.22 million estimate. The quarter's net income of $70.1 million included a one-time $194.0 million net gain from the sale of a Priority Review Voucher. AVLAYAH net product revenue totaled $17.8 million in its second full commercial quarter following FDA approval in March 2026. The company issued fourth-quarter 2026 net product revenue guidance of $30.0 million to $32.0 million. "Families and physicians are telling us that AVLAYAH is making a difference for children with Hunter syndrome, and the results this quarter reflect that," said Ryan Watts, Chief Executive Officer of Denali Therapeutics. AVLAYAH, the first FDA-approved medicine leveraging the transferrin receptor to cross the blood-brain barrier, is approved for treating neurologic manifestations of Hunter syndrome. Coverage now exceeds 70% of U.S. commercial lives, up from more than 50% in the prior quarter, and 20 state Medicaid programs have published coverage. A permanent J-code became effective October 1, 2026, streamlining billing and reimbursement. The company is advancing zafinofusp alfa as its second potential product, with a Biologics License Application submission on track for 2027 seeking accelerated approval for Sanfilippo syndrome type A. The Phase 1/2 study completed its prespecified treatment duration for the primary endpoint in the third quarter, enrolling 20 participants. Research and development expenses totaled $106.1 million, compared to $102.0 million in the third quarter of 2025. Selling, general and administrative expenses were $37.5 million, up from $35.5 million YoY. Cash, cash equivalents and marketable securities stood at approximately $1.0 billion as of September 30, 2026. Original Article