Denali reports Q1 2026 net loss $128.4M; AVLAYAH approved and launched for Hunter syndrome

Denali Therapeutics Inc.

2026-Q1 EPS reported -$0.69

Net loss of $128.4M for Q1 2026 vs $133.0M in Q1 2025; R&D expenses down $12.4M to $103.8M.
FDA granted accelerated approval for AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome on March 25, 2026; first commercial patients dosed in April.
Cash and marketable securities at $1.05B as of March 31, 2026; $200M gross proceeds received from Royalty Pharma synthetic royalty agreement.
Takeda terminated DNL593 (FTD-GRN) collaboration; Denali retains full rights, Phase 1/2 data expected by end of 2026.
First patient dosed in Phase 1b study of DNL628 (OTV:MAPT) for Alzheimer's disease; data expected in 1H 2027.

item 2.02 item 9.01

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Denali Therapeutics Inc. reported financial results for the first quarter ended March 31, 2026.

Period: the first quarter ended March 31, 2026
Result: reported results

Exact text from the filing

On May 7, 2026, Denali Therapeutics Inc. (the "Company") issued a press release announcing its financial results for the first quarter ended March 31, 2026.

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Denali Therapeutics Inc. filing history →

Source: SEC EDGAR

accession 0001714899-26-000062

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