8-K current report · filed Jun 18, 2026

Denali Therapeutics Inc. (DNLI) 8-K Current Report: June 18, 2026

Item 1.01Item 7.01DNLI overview

Short answer

Denali Therapeutics Inc. (DNLI) filed an 8-K current report with the SEC on June 18, 2026 reporting Item 1.01 (Entry into a Material Definitive Agreement), Item 7.01 (Regulation FD Disclosure). $195 million cash proceeds upon closing from sale of FDA Rare Pediatric Disease Priority Review Voucher.

Denali Therapeutics Inc. 8-K event analysis

AI summary of each reported item and its exhibits

Item 1.01 · Entry into a Material Definitive Agreement

  • $195 million cash proceeds upon closing from sale of FDA Rare Pediatric Disease Priority Review Voucher
  • Voucher awarded after AVLAYAH approval for Hunter syndrome in March 2026
  • Closing subject to customary conditions, including Hart-Scott-Rodino antitrust waiting-period clearance
  • Agreement includes customary representations, covenants, and indemnification provisions with limitations

Item 7.01 · Regulation FD Disclosure

  • Denali issued a June 18, 2026 press release under Regulation FD, making material information broadly available
  • Full disclosure details appear in Exhibit 99.1, which investors should review for the event’s financial or clinical implications

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