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AI brief of an SEC Form 8-K · Denali Therapeutics Inc. (DNLI)

Denali Therapeutics Q3 net income $70.1 million on $17.8 million AVLAYAH sales

Positive Impact 3 of 5 earnings Written later

Denali Therapeutics reported third-quarter 2026 results with $17.8 million in net product revenue from AVLAYAH, its first approved medicine, and guided fourth-quarter net product revenue to $30.0 million to $32.0 million. Net income of $70.1 million was driven by a one-time $194.0 million gain on the sale of a Priority Review Voucher, while the operating loss stayed large at $126.8 million.

Key points

  • Net product revenue was $17.8 million for the quarter ended September 30, 2026, the second full quarter of AVLAYAH sales; the prior-year quarter had no product revenue.
  • Net income was $70.1 million, or $0.37 per diluted share, compared with a net loss of $126.9 million a year earlier, including a one-time $194.0 million gain on a Priority Review Voucher sale.
  • Loss from operations was $126.8 million, with research and development expenses of $106.1 million and selling, general and administrative expenses of $37.5 million.
  • Fourth-quarter 2026 net product revenue is expected to be $30.0 million to $32.0 million; cash, cash equivalents and marketable securities were about $1.0 billion as of September 30, 2026.

The filing

CompanyDenali Therapeutics Inc. (DNLI)
Form8-K, current report
Filed with the SECNov 3, 2026, 4:03 PM ET
Accession number0001714899-26-000107

Items reported: 2.02 Results of Operations

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on November 03, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.