Denali Therapeutics (DNLI) Company Report

Denali Therapeutics is preparing for the April 5th PDUFA date for tividenofusp alfa (TIVI), its treatment for Hunter syndrome, following Phase 1/2 study results that demonstrated sustained reductions in CNS and peripheral biomarkers, along with improvements in cognition, behavior, and hearing, and a manageable safety profile.
Preliminary Phase 1/2 data for DNL126 in Sanfilippo syndrome showed an 80% mean reduction in CSF heparan sulfate at week 49 and substantial reductions in other biomarkers, with the company expecting to file for accelerated approval in 2027.
Preclinical data for ETV-GAA (DNL952) in Pompe disease demonstrated enhanced correction of skeletal muscle and brain pathology, with a Phase 1 clinical study ongoing and biomarker proof-of-concept data expected in 2027.

3 hours ago

Transcript

Denali Therapeutics Presents Clinical Program Updates for Lysosomal Storage Disorders

DNLI

New Projects/Investments

Product Launch

Guidance Update

Denali Therapeutics announced progress for tividenofusp alfa (DNL310) for Hunter syndrome (MPS II), with a Prescription Drug User Fee Act (PDUFA) date of April 5, 2026, and established launch readiness.
Preliminary Phase 1/2 data for DNL126 (ETV:SGSH) in Sanfilippo syndrome type A (MPS IIIA) demonstrated an 80% mean reduction in CSF heparan sulfate, with a Biologics License Application (BLA) submission and potential approval anticipated in 2027.
The company also presented the Phase 1 clinical study design and preclinical data for DNL952 (ETV:GAA) for Pompe disease, highlighting its therapeutic potential.

7 hours ago

Press Release

Denali Nears First Approval for Hunter Syndrome Treatment and Advances Pipeline

DNLI

Product Launch

New Projects/Investments

Guidance Update

Denali is on the cusp of its first approval for its TransportVehicle (TV) technology in Hunter syndrome, with a PDUFA date of April 5th. The company anticipates minimal revenues in 2026 but projects a strong inflection point in 2027.
The company is advancing its pipeline with the Sanfilippo program (DNL126) targeting BLA submission and approval by 2027, and has filed for OTV:MAPT and plans to file for ATV:Abeta in early 2026 for Alzheimer's disease, with data expected in 2027 for both.
Denali estimates that the Hunter syndrome and Sanfilippo rare disease launches could capture a $1 billion+ market , and its strategic goals for the next three years include delivering two growing brands and achieving five clinical proof of concepts.

Jan 13, 2026, 9:30 PM

Transcript

Denali Therapeutics Outlines Near-Term Product Launches and Pipeline Milestones

DNLI

Product Launch

New Projects/Investments

Guidance Update

Denali Therapeutics is preparing for two near-term product launches: tividenofusp alfa (DNL310) in 2026 and DNL126 in 2027, targeting a $1B+ market opportunity in Lysosomal Storage Disorders.
Key milestones expected in 1H 2026 include the tividenofusp alfa approval decision with a PDUFA Target Action Date of April 5, 2026, and ETV:SGSH Phase 1/2 data at the WORLD Symposium.
The company plans IND/CTA submission for DNL921 (ATV:Abeta) in 1H 2026 and Phase 1b initiation for DNL628 (OTV:MAPT) in 1H 2026, with clinical proof of concept and biomarker data for these Alzheimer's programs anticipated in 2027.
Denali reported a strong financial foundation with approximately $873 million in cash and investments as of Q3 2025, supplemented by an additional $488 million from royalty financing and an equity capital raise in December 2025.

Jan 13, 2026, 9:30 PM

Presentation

Denali Therapeutics provides updates on pipeline, regulatory milestones, and commercial strategy

DNLI

Product Launch

New Projects/Investments

Guidance Update

Denali is on the cusp of its first approval for TIVI in Hunter syndrome, with a PDUFA date of April 5th. The company anticipates minimal revenues in 2026 for TIVI, with a strong inflection point in 2027 as payer coverage expands.
The company projects a $1 billion-plus market for its rare disease launches, including TIVI for Hunter syndrome and SGSH for Sanfilippo, with a goal to submit the BLA for SGSH and achieve approval by 2027.
Denali is expanding its portfolio into Alzheimer's disease, having filed for OTV MAPT and planning to file for ATV A beta at the beginning of this year to initiate clinical studies.
Strategic goals for the next three years (D3x3) include delivering two growing brands (Hunter and Sanfilippo), achieving five clinical proof of concepts, and advancing four to six additional programs into the clinic.

Jan 13, 2026, 9:30 PM

Transcript

Denali Therapeutics Nears First Approval and Outlines Strategic Pipeline Expansion

DNLI

Product Launch

New Projects/Investments

Guidance Update

Denali is on the cusp of its first approval for TIVI in Hunter syndrome, with expectations to capture a $1 billion-plus market through rare disease launches including Sanfilippo.
The company is expanding its pipeline into Alzheimer's disease, with plans to file for OTV MAPT and ATV A beta clinical studies at the beginning of this year.
For the TIVI launch in Hunter syndrome, Denali projects minimal revenues in 2026 due to initial access challenges, but anticipates a strong inflection point in 2027 as coverage expands, with pricing set at a premium.
Over the next three years, Denali aims to deliver two growing brands, achieve five clinical proof of concepts, and advance an additional four to six programs into the clinic, supported by a strong financial position.

Jan 13, 2026, 9:30 PM

Transcript

Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026

DNLI

Product Launch

New Projects/Investments

Guidance Update

Denali Therapeutics Inc. is preparing for the commercial launch of tividenofusp alfa for Hunter syndrome, with an FDA PDUFA target action date of April 5, 2026.
The company anticipates multiple clinical data readouts in 2026 for pipeline programs, including DNL126 for Sanfilippo syndrome Type A, TAK-594/DNL593 for FTD-GRN, and BIIB122/DNL151 for Parkinson's disease.
Denali plans to initiate first-in-human clinical studies for DNL628 (Alzheimer's disease) and DNL952 (Pompe disease) in the first half of 2026.
As of September 30, 2025, Denali reported approximately $872.9 million in cash, cash equivalents, and marketable securities, supplemented by a $200 million equity financing and up to $275 million royalty funding in December 2025.

Jan 6, 2026, 1:02 PM

8-K

Denali Therapeutics Publishes Positive Phase 1/2 Results for Tividenofusp Alfa and Awaits FDA Decision

DNLI

Product Launch

New Projects/Investments

Denali Therapeutics announced the publication of positive Phase 1/2 clinical trial results for its investigational enzyme replacement therapy, tividenofusp alfa (DNL310), for Hunter syndrome (MPS II) in The New England Journal of Medicine.
The trial data demonstrated reduction and normalization in key disease biomarkers and stabilization or improvement in clinical endpoints including adaptive behavior, cognition, hearing, and liver volume. The most common treatment-related adverse events were infusion-related reactions, which decreased with continued use.
Tividenofusp alfa is engineered to cross the blood-brain barrier, aiming to treat neurological manifestations of MPS II in addition to physical symptoms.
The Biologics License Application for tividenofusp alfa is under FDA Priority Review, with a Prescription Drug User Fee Act (PDUFA) date of April 5, 2026.

Dec 30, 2025, 1:00 PM

Press Release

Denali Therapeutics Prices Public Offering of Common Stock and Warrants

DNLI

Denali Therapeutics Inc. announced the pricing of an underwritten public offering, which includes 9,142,857 shares of common stock at $17.50 per share and 2,285,714 pre-funded warrants at $17.49 per pre-funded warrant.
The pre-funded warrants are exercisable at $0.01 per share.
The company granted the underwriters a 30-day option to purchase up to an additional 1,714,285 shares of common stock.
The offering is expected to generate approximately $200 million in gross proceeds, or $230 million if the underwriters' option is fully exercised, and is anticipated to close on or about December 11, 2025.

Dec 10, 2025, 10:21 PM

8-K

Denali Therapeutics Prices Public Offering

DNLI

Denali Therapeutics Inc. priced an underwritten public offering of 9,142,857 shares of common stock at $17.50 per share and 2,285,714 pre-funded warrants at $17.49 per pre-funded warrant.
The company expects to receive approximately $200 million in total gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, and excluding any exercise of the underwriters’ option.
Denali Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,714,285 shares of its common stock.
The offering is anticipated to close on or about December 11, 2025, subject to customary closing conditions.