Denali pipeline update: DNL952 on clinical hold; PDUFA date Apr 2026 for Hunter syndrome

Denali Therapeutics Inc.

BLA for tividenofusp alfa (Hunter syndrome) under FDA review; PDUFA target action date April 5, 2026. Enrollment in Cohort A expected to complete Dec 2025.
DNL126 (MPS IIIA) Phase 1/2 on track for completion 2026; potential accelerated approval and commercial launch by end of 2027. Initial data at 2026 WORLD Symposium.
IND for DNL952 (Pompe) placed on clinical hold; FDA requested protocol amendments (lower starting dose, revised inclusion criteria). Denali has responded, minimal delays expected.
Phase 1b study of DNL628 (Alzheimer's) expected to begin 1H 2026; CTA submitted. Regulatory submission for DNL921 planned 1H 2026.
BIIB122 (Parkinson's) Phase 2b readout expected 2026. Eclitasertib (ulcerative colitis) Phase 2 data expected 1H 2026.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.