Flash FinanceUS
Pre-market S&P 5007,549.94+2.35% Nasdaq25,253.14+2.74% Dow 3052,389.75+2.15% Russell 20002,840.81+3.15% Nasdaq-10027,907.62+3.40% MidCap 4003,715.23+3.13% SmallCap 6001,722.37+2.89% VIX19.92-22.31% 10Y Yield4.86+0.10% Close of Nov 09, 2026
AI brief of an SEC Form 8-K · Denali Therapeutics Inc. (DNLI)

Denali Therapeutics Q2 2026 AVLAYAH sales $3.6 million; net loss $127.6 million

Mixed Impact 3 of 5 earnings Written later

Denali Therapeutics reported second-quarter 2026 results, its first full quarter selling AVLAYAH, the Hunter syndrome therapy approved in March 2026. Net product revenue was $3.6 million, but the net loss widened to $127.6 million from $124.1 million a year earlier. The company projects third-quarter AVLAYAH net product revenue of $10.0 million to $12.0 million and said pro forma cash, cash equivalents and marketable securities exceeded $1.1 billion after a $195 million priority review voucher sale.

Key points

  • AVLAYAH generated $3.6 million in net product revenue in the quarter ended June 30, 2026, following FDA approval in March 2026.
  • Net loss was $127.6 million for the quarter, compared with $124.1 million a year earlier; research and development expenses fell to $97.0 million from $102.7 million.
  • Projected third-quarter 2026 AVLAYAH net product revenue is $10.0 million to $12.0 million.
  • Cash, cash equivalents and marketable securities were about $940.0 million on June 30, 2026; the $195.0 million priority review voucher sale closed in July 2026.

The filing

CompanyDenali Therapeutics Inc. (DNLI)
Form8-K, current report
Filed with the SECAug 6, 2026, 4:03 PM ET
Accession number0001714899-26-000096

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 August 06, 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.