Every material Form 8-K Denali Therapeutics Inc. has filed with the SEC since July 27, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
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.
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.
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.
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.
Denali Therapeutics completed the sale of its Rare Pediatric Disease Priority Review Voucher to a large pharmaceutical company on July 27, 2026, receiving gross proceeds of $195.0 million at closing. The voucher was received when the FDA approved AVLAYAH (tividenofusp alfa) for Hunter syndrome in March 2026, and the sale was made under an asset purchase agreement dated June 12, 2026.
Gross proceeds of $195.0 million received from the buyer at closing on July 27, 2026
Voucher received when FDA approved AVLAYAH (tividenofusp alfa) for Hunter syndrome (MPS II) in March 2026
Sale made under asset purchase agreement dated June 12, 2026; buyer not named in the filing
Full agreement to be filed as an exhibit to a later SEC filing
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