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NASDAQ: DNLI Denali Therapeutics Inc. 10-Q

revenue $3.6M, net income -$127.6M. PRV sold

Filed August 6, 2026 · Period ending June 30, 2026 · Compared to 10-Q Aug 11, 2025 · ~1 min read

Key Changes

  • high

    AVLAYAH launched April 2026 following March FDA accelerated approval, generating $3.6M in first-quarter product revenue. Approval triggered $200M Royalty Pharma funding (9.25% royalty on net sales, capped at 2.5x–3.0x) and a $36M milestone payment to F-star Gamma.

    MD&A: AVLAYAH commercialization; Notes: Revenue recognition verify on EDGAR →
  • high

    Company sold Priority Review Voucher received with AVLAYAH approval for $195M gross proceeds in July 2026 (subsequent event). Proceeds and gain will appear in Q3 2026 results.

    Notes: Subsequent events view on EDGAR →
  • high

    Takeda terminated DNL593 (PTV:PGRN) collaboration in June 2026, returning all rights to Denali. Termination driven by Takeda's strategic considerations, not efficacy or safety. Denali continues Phase 1/2 study independently.

    MD&A: Takeda collaboration; Notes: Collaboration termination verify on EDGAR →

2 more material changes behind this preview — plus the full narrative summary, section-by-section diffs against the prior filing, and verbatim quotes with EDGAR citations.

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Figures/quotes linked to EDGAR · Narrative written by AI · Aug 26, 2026 · How we verify