Denali Therapeutics Inc.
1 products tracked · names used in filings: Denali Therapeutics Inc.
Upcoming milestones
No upcoming milestones listed.
Recent milestones
Sun 05 Apr 2026🇺🇸 PDUFA datecompany-announced
tividenofusp alfa (DNL310; ETV:IDS): PDUFA target action date (Hunter syndrome (MPS II))
Denali Therapeutics Inc. (DNLI); tividenofusp alfa; BLA; status: set; "…Tividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndrome • DNL126 (ETV:SGSH) Phase 1/2 preliminary"; filed 2026-02-26 · source
Tue 24 Mar 2026🇺🇸 FDA approval
FDA approves Avlayah (tividenofusp alfa-eknm), a new medicine
Denali Therapeutics Inc.; BLA761485; New biologic, Priority review; injection · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇺🇸 | Avlayah tividenofusp alfa-eknm | Approved | 2026-03-24 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.