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Denali Therapeutics Inc.

DNLI
$1.90B
Small Cap
NASDAQBiological Products, (No Diagnostic Substances)🇺🇸North AmericaSOUTH SAN FRANCISCO517 employees

Drugs in Pipeline

5

Phase 3 Programs

2

Upcoming Catalysts

5

Next Catalyst

Apr 30, 2026

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Data is aggregated from public sources (FDA, SEC, ClinicalTrials.gov). While we strive for accuracy, information may be incomplete, delayed, or contain errors. Terms apply

Market Overview

Stock performance and market intelligence

Catalyst Timeline

5 upcoming, 0 past

Phase 2Next

BIIB122 225 mg Phase 2 Results Expected

Apr 30, 2026BIIB122 225 mg50

Primary completion for BIIB122 225 mg trial (NCT06602193) in Parkinson Disease

Source
🎯PDUFA

FDA PDUFA Date DNLI-7001 (priority)

5/1/2026

For Alzheimer's disease. NDA filing. Extracted from SEC filing: 8-K

Source
🎯PDUFA

FDA PDUFA Date DNL310 (standard)

June 2026~

For Hunter syndrome. BLA filing. Extracted from SEC filing: 8-K

Source
🎯PDUFA

FDA PDUFA Date NEDD4-L inhibitor DNL310 (priority)

7/7/2026

For Mucopolysaccharidosis Type II (MPS II). BLA filing. Extracted from SEC filing: 8-K

Source
Phase 2

DNL593 Phase 2 Results Expected

December 2026~DNL59385

Primary completion for DNL593 trial (NCT05262023) in Frontotemporal Dementia

Source

AI Predictions & Institutional Flow

Machine learning insights and smart money movement

FDA Submissions

Pending NDA/BLA submissions with predicted PDUFA dates

Drug Pipeline

Clinical development programs and drug candidates

Drug Pipeline

idursulfase

Phase 3

Mucopolysaccharidosis II

tividenofusp alfa

Phase 3

Mucopolysaccharidosis II

DNL126

Phase 2

Mucopolysaccharidosis Type IIIA

DNL593

Phase 2

Frontotemporal Dementia

BIIB122 225 mg

Phase 2

Parkinson Disease

Regulatory & News

Approvals, filings, and latest developments

Regulatory Approvals
DNLI News