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Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

DNLI
  • FDA granted accelerated approval to AVLAYAH™ (tividenofusp alfa-eknm) for treating neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients weighing at least 5 kg, marking the first medicine to utilize the transferrin receptor to cross the blood-brain barrier
  • AVLAYAH launched commercially in the U.S. in April 2026 with the first patients treated within one month of approval, supported by an established distribution channel, patient support hub, and engagement with major health systems and payers
  • Denali Therapeutics received a Rare Pediatric Disease Priority Review Voucher from the FDA in conjunction with the AVLAYAH approval
  • The first patient was dosed in the Phase 1b study of DNL628 (OTV:MAPT) targeting tau for Alzheimer's disease in March 2026, with data expected in the first half of 2027
  • Denali advanced DNL593 (PTV:PGRN) for GRN-related frontotemporal dementia in a Phase 1/2 study after regaining full rights following a collaboration termination with Takeda, with results expected by the end of 2026
  • Phase 1/2 trial of DNL126 (ETV:SGSH) for Sanfilippo syndrome type A is ongoing with global Phase 3 start-up activities underway, targeting a BLA submission and potential accelerated approval in 2027
  • Phase 1 study start-up activities are underway for DNL952 (ETV:GAA) for Pompe disease
  • A clinical data readout for the Phase 2b LUMA study of BIIB122 (small molecule LRRK2 inhibitor) for Parkinson's disease is expected in mid-2026
  • Denali expects to submit a regulatory filing for DNL921 (ATV:Abeta) for Alzheimer's disease in the first half of 2026
  • Denali raised $200 million in gross proceeds in March 2026 from a synthetic royalty funding agreement with Royalty Pharma
  • Net loss for the first quarter ended March 31, 2026, was $128.4 million, a decrease from $133.0 million in the same period in 2025
  • Research and development expenses totaled $103.8 million for the quarter, while general and administrative expenses increased to $33.5 million due to higher personnel costs supporting AVLAYAH launch activities
  • As of March 31, 2026, Denali held approximately $1.05 billion in cash, cash equivalents, and marketable securities