Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $13.7552W HIGH $27.30
Volume
2.37 M
Value Traded
38.76 M
Short % Float
11.45%
-6.65%Week
-13.44%1 Month
-27.3%3 Month
-2.91%6 Month
-68.78%5 Year
-13.5%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
2.98 B
EPS (TTM)
-3.20
P/E Ratio
-
Ent. Value
2.04 B
Total Shares
159.83 M
Float Shares
149.71 M
Insiders
6.34%
Institutions
97.94%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
PoA blends historical approval base rates, trial design score and FDA review track record.
DNLI Catalyst Timeline
Dated clinical, regulatory and corporate events for Denali Therapeutics Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Denali Therapeutics Inc.
715Total events
20Upcoming
156Tier-1 (high impact)
2017 to 2029Coverage
Upcoming catalysts 2
Event history 50
▲Enrollment CompleteDNL593Trial
Enrollment in Phase 1/2 study of DNL593 complete with 40 participants
FTD-GRNsource ↗
●Trial InitiationTrial
Start-up activities underway for global Phase 3 confirmatory study of zafinofusp alfa
Sanfilippo syndrome type Asource ↗
▲Trial InitiationDNL593Trial
Enrollment in Phase 1/2 study of DNL593 completed with 40 participants
FTD-GRNsource ↗
▲Orphan Drug DesignationDNL593Designation
FDA granted Orphan Drug Designation to DNL593 for FTD-GRN
FTD-GRNsource ↗
▲PRV SoldDesignation
Denali sold Rare Pediatric Disease Priority Review Voucher for $195 million
●Oral PresentationPresentation
Dr. Watts delivered opening plenary at Alzheimer's Association International Conference
▲Timing GuidanceAVLAYAHPresentation
Projected Q3 2026 AVLAYAH net product revenue of $10.0M-$12.0M
Hunter syndrome (MPS II)source ↗
▲Product LaunchAVLAYAHPost-Market
AVLAYAH generated $3.6 million in net product revenue in first full quarter of launch
Hunter syndrome (MPS II)source ↗
▲PRV SoldDesignation
Denali sells Rare Pediatric Disease Priority Review Voucher for $195 million
◆FDA Approvaltividenofusp alfaApprovedFDA Decision
US accelerated approval expected in 1H 2026
Hunter syndrome (MPS II)source ↗
◆Product Launchtividenofusp alfaApprovedPost-Market
Commercial launch of tividenofusp alfa in anticipation of FDA approval
Hunter syndrome (MPS II)source ↗
◆Topline ReadoutDNL126Clinical Data
Phase 1/2 data expected in 1H 2026
Sanfilippo syndrome Type A (MPS IIIA)source ↗
◆Trial InitiationDNL628Trial
Phase 1b study initiation expected in 1H 2026
Alzheimer's diseasesource ↗
▲Trial InitiationDNL952Trial
Dosing of participants with late-onset Pompe disease began in Phase 1 study of DNL952
Pompe diseasesource ↗
◆Topline ReadoutBIIB122Clinical Data
Phase 2b LUMA data expected in 1H 2026
Parkinson's diseasesource ↗
◆Topline ReadoutSAR443122Clinical Data
Phase 2 results expected in first half of 2026
ulcerative colitissource ↗
◆Trial InitiationDNL921Trial
Phase 1/1b study initiation expected in 1H 2026
Alzheimer's diseasesource ↗
▼Topline ReadoutBIIB122Clinical Data
Phase 2b LUMA study topline results: did not meet primary or secondary endpoints
Early-stage Parkinson's diseasesource ↗
▼Program DiscontinuationBIIB122Corporate
Biogen and Denali discontinue development of BIIB122 in idiopathic Parkinson's disease
Idiopathic Parkinson's diseasesource ↗
▲Enrollment CompleteDNL593Trial
Enrollment completed in Phase 1/2 study of DNL593 with 40 participants
GRN-related frontotemporal dementia (FTD-GRN)source ↗
▼Trial DiscontinuedDNL151Trial
Discontinued further development of DNL151 in idiopathic Parkinson's disease after LUMA missed endpoints
Parkinson's disease (idiopathic)source ↗
▼Primary Endpoint MissedDNL151Clinical Data
LUMA study of DNL151 did not meet primary or secondary endpoints
Parkinson's diseasesource ↗
▼Program DiscontinuationDNL151Corporate
Denali and Biogen decided to discontinue further development of DNL151 in idiopathic Parkinson's disease
Parkinson's diseasesource ↗
▼Trial Stopped FutilityDNL151Trial
Phase 2b LUMA study of DNL151 did not meet primary or secondary endpoints
Parkinson's diseasesource ↗
◆PDUFA Datetividenofusp alfaApprovedRegulatory Filing
PDUFA target action date for tividenofusp alfa BLA under Priority Review
Hunter syndrome (MPS II)source ↗
◆PDUFA Extensiontividenofusp alfaApprovedRegulatory Filing
FDA extends PDUFA date for tividenofusp alfa BLA from January 5, 2026 to April 5, 2026
Mucopolysaccharidosis type II (Hunter syndrome)source ↗
▲Partnership / LicenseDNL593Corporate
Takeda terminates collaboration on DNL593; Denali regains full rights
frontotemporal dementia-granulin (FTD-GRN)source ↗
▲Enrollment CompleteDNL593Trial
Enrollment completed with 40 participants in Phase 1/2 study
frontotemporal dementia-granulin (FTD-GRN)source ↗
◆Topline ReadoutBIIB122Clinical Data
Topline data expected from LUMA study
Parkinson's diseasesource ↗
▲Product Launchtividenofusp alfaApprovedPost-Market
U.S. commercial launch of AVLAYAH with first patients treated
Hunter syndrome (MPS II)source ↗
◆Topline ReadoutBIIB122Clinical Data
Clinical data readout from Phase 2b LUMA study of BIIB122 expected in mid-2026
Parkinson's diseasesource ↗
▼Partnership / LicenseDNL593Corporate
Takeda terminated collaboration agreement for DNL593
FTD-GRNsource ↗
▲First Patient DosedDNL952Trial
Dosing of participants with late-onset Pompe disease began in Phase 1 study of DNL952
Pompe diseasesource ↗
●Debt Royalty FinancingCorporate
Denali received $200 million gross proceeds from Royalty Pharma synthetic royalty funding agreement
▲FDA Approvaltividenofusp alfaApprovedFDA Decision
FDA accelerated approval of AVLAYAH for Hunter syndrome
Hunter syndrome (MPS II)source ↗
▲PRV Grantedtividenofusp alfaApprovedDesignation
Rare Pediatric Disease Priority Review Voucher granted
Hunter syndrome (MPS II)source ↗
▲PRV GrantedDesignation
FDA granted Rare Pediatric Disease PRV to Denali in connection with AVLAYAH approval
▲FDA Approvaltividenofusp alfaApprovedFDA Decision
FDA accelerated approval of AVLAYAH for Hunter syndrome
Hunter syndrome (MPS II)source ↗
▲First Patient DosedDNL628Trial
First patient dosed in Phase 1b study of DNL628 for Alzheimer's disease
Alzheimer's diseasesource ↗
Past FDA Catalysts and PDUFA Decisions
How DNLI actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-30 | BIIB122 / DNL151 (small molecule LRRK2 inhibitor) | Phase 2b data readout | Phase 2b |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
C50 / 100
Pipeline Score
$703M
Pipeline Value
$15M
Commercial Value
Richly Valued
Valuation Signal
9
Drugs Scored
0.2x
rNPV / MCap
Top 18%
Small Cap(rank 119 of 658)
Percentile Rank
Denali Therapeutics Inc. carries a moderate pipeline score (50/100), with $1.1B risk-adjusted pipeline value, led by BIIB122 in Parkinson Disease (Phase 2).
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines: last four quarters to Jun 2026 (10-K and 10-Q)) Revenue $3.6M x 4.2 = $15M
| Product | Revenue | Prior period | Change |
|---|---|---|---|
| AVLAYAH | $4M | - | - |
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| BIIB122 Small moleculeNCT06602193 | Parkinson Disease | Phase 2 | ACTIVE NOT_RECRUITING | 50 | Feb 28, 2028 |
Clinical Trial Results
Readouts, endpoints and source filings for every DNLI program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| BIIB122 | early-stage Parkinson's disease | Phase 2b | 2026-05-21 | 90% kinase inhibition of peripheral LRRK2 (phosphoserine 935); up to approximately 30% reduction observed in a biomarker of LRRK2 activity (phosphorylated Rab10)Read More | Biogen and Denali Therapeutics Provide Update on Phase 2b LUMA Study of BIIB122 (DNL151) in Early-Stage Parkinson's Disease The Phase 2b LUMA study of BIIB122 in early-stage Parkinson's disease did not meet its primary oRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Chin Peter ScottOfficer (Chief Medical Officer) | Sell | -1,654 204,538 held | $22.29 | 09/04/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in DNLI
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| BAKER BROS. ADVISORS | 0.5 % (25 %) | 96.05 M | 3.73 M | 0.07% ( 2.64 K) |
DNLI Institutional Ownership Trends
Options Data
Option Volume
Open Interest
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Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
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Put Vol
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Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
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| Last | Vol | OI | Last | Vol | OI | |
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Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How DNLI ranks across every disease it competes in
Competitive Position is a premium feature
See how DNLI ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialDNLI News
DNLIDenali Therapeutics Reports Second Quarter 2026 Financial Results and Business Highlights
Denali Therapeutics reported its second quarter 2026 financial results, highlighting a successful launch of AVLAYAH, which generated $3.6 million in revenue. The company also advanced two Alzheimer's disease programs into clinical development and received $195 million from a Priority Review Voucher sale, boosting its cash reserves to over $1.1 billion. However, Denali faced a net loss of $127.6 million during the quarter.
Read more →DNLIDenali Therapeutics to Report Second Quarter 2026 Financial Results and Business Highlights on August 6, 2026
Denali Therapeutics Inc. will report its second quarter 2026 financial results on August 6, 2026. Following the announcement, a conference call and webcast will be held to discuss the results and provide a business update. The company is known for its innovative biotherapeutics aimed at treating neurodegenerative diseases.
Read more →DNLI▼ -5.6%on this news
Denali Therapeutics to Give Opening Plenary Address at Alzheimer’s Association International Conference (AAIC) 2026 and Highlight Breakthroughs in Delivering Biologic Therapies Across Blood-Brain Barrier
Denali Therapeutics will present at the Alzheimer's Association International Conference 2026, focusing on breakthroughs in delivering therapies across the blood-brain barrier. CEO Ryan Watts will discuss advancements in neurodegenerative disease treatments, including investigational therapies DNL628 and DNL921. Denali's proprietary TransportVehicle™ technology aims to enhance drug delivery to the brain.
Read more →DNLIDenali Therapeutics Enters Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $195 Million
Denali Therapeutics has announced a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for $195 million. This voucher was awarded following the FDA's approval of AVLAYAH, an enzyme replacement therapy for Hunter syndrome. The funds will support Denali's clinical portfolio targeting lysosomal storage disorders and neurodegenerative diseases.
Read more →DNLIBiogen and Denali Therapeutics Provide Update on Phase 2b LUMA Study of BIIB122 (DNL151) in Early-Stage Parkinson's Disease
Biogen and Denali Therapeutics announced that the Phase 2b LUMA study of BIIB122 (DNL151) for early-stage Parkinson's disease failed to meet its primary and secondary endpoints, prompting the discontinuation of the drug's development for idiopathic Parkinson's disease. Despite this setback, exploratory biomarker data showed promising kinase inhibition, and Denali plans to continue the Phase 2a BEACON study focused on patients with a specific LRRK2 variant. Findings from the LUMA study will be presented at an upcoming scientific conference for greater understanding of Parkinson's disease.
Read more →DNLIDenali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights
Denali Therapeutics reported its Q1 2026 financial results, highlighting the FDA approval of AVLAYAH for Hunter syndrome. The company launched AVLAYAH in the U.S. with strong momentum, and its clinical pipeline is advancing, including therapies for Alzheimer's and frontotemporal dementia. Despite a net loss of $128.4 million, Denali remains focused on its innovative TransportVehicle platform and upcoming studies.
Read more →DNLI▼ -6.2%on this news
Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)
Denali Therapeutics has regained full rights to DNL593 after Takeda terminated their collaboration. The investigational therapy aims to deliver progranulin to the brain for treating frontotemporal dementia (FTD-GRN). Denali plans to continue its clinical development independently and expects results from the ongoing Phase 1/2 study by the end of 2026.
Read more →DNLIDenali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
Denali Therapeutics has received FDA approval for AVLAYAH (tividenofusp alfa-eknm), the first enzyme replacement therapy specifically targeting Hunter syndrome, a rare genetic disorder. This marks a significant advancement as it is the first FDA-approved treatment in nearly two decades designed to penetrate the blood-brain barrier. The approval is based on promising results from a Phase 1/2 trial, with ongoing studies to confirm clinical benefits.
Read more →DNLIDenali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
Denali Therapeutics has reported its fourth quarter and full year 2025 financial results, highlighting significant advancements in its clinical programs. The company is preparing for the launch of tividenofusp alfa for Hunter syndrome, with a PDUFA date set for April 5, 2026. Preliminary data presented for DNL126 indicate potential for accelerated approval in Sanfilippo syndrome type A. Additionally, Denali is advancing studies for treatments targeting Alzheimer's disease and Pompe disease, while managing fiscal challenges reflected in increased net losses.
Read more →DNLI▼ -5.9%on this news
Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™
Denali Therapeutics presented updates on its Enzyme TransportVehicle™ (ETV) programs targeting lysosomal storage disorders at the WORLDSymposium. Notable findings include substantial reductions in disease biomarkers for DNL310 in Hunter syndrome and DNL126 in Sanfilippo syndrome type A, suggesting their efficacy. The company is preparing for a potential commercial launch of tividenofusp alfa by April 5, 2026, alongside ongoing studies for DNL952 in Pompe disease. The data reinforce the potential of Denali's therapies to address significant unmet needs in patients with these debilitating conditions.
Read more →DNLIDenali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™
Denali Therapeutics announced a live webcast to discuss its Enzyme TransportVehicle™ programs at the 22nd Annual WORLDSymposium™. The event will take place from February 2-6, 2026, in San Diego, California. The webcast aims to highlight the potential of enzyme replacement therapies to deliver treatment throughout the body, including the brain.
Read more →DNLIDenali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™
Denali Therapeutics announced that it will present data on its Enzyme TransportVehicle™ programs at the 2026 WORLDSymposium™. The presentations will include follow-up data from ongoing Phase 1/2 studies for Hunter syndrome and Sanfilippo syndrome type A, as well as details on a Phase 1 study for Pompe disease. The FDA is reviewing the Biologics License Application for tividenofusp alfa, with a decision expected by April 2026.
Read more →DNLI▲ +7.4%on this news
Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome
Denali Therapeutics has announced key milestones and priorities for 2026, including the anticipated commercial launch of tividenofusp alfa for Hunter syndrome. The company is preparing for an FDA decision on the drug's accelerated approval, with a projected action date of April 5, 2026. Additionally, Denali plans to initiate clinical trials for new therapies targeting Alzheimer's disease and Pompe disease while also expecting multiple clinical data readouts that could enhance their portfolio's value in neurodegenerative and lysosomal storage diseases.
Read more →DNLIThe New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics’ Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II)
Denali Therapeutics announced the publication of Phase 1/2 trial results for tividenofusp alfa, an enzyme replacement therapy for Hunter syndrome, in The New England Journal of Medicine. The FDA is reviewing the Biologics License Application for accelerated approval, with a decision expected by April 2026. The therapy aims to address both cognitive and physical symptoms of the disease, which currently lacks effective treatment options.
Read more →DNLI▼ -10.6%on this news
Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants
Denali Therapeutics has announced the pricing of its public offering, aiming to sell over 9 million shares of common stock at $17.50 each, alongside pre-funded warrants. The company anticipates total gross proceeds of around $200 million before expenses related to the offering. Notably, underwriters have a 30-day option to purchase additional shares, showcasing confidence in demand. The offering is expected to close on or about December 11, 2025, pending customary closing conditions.
Read more →DNLIDenali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants
Denali Therapeutics announced a proposed offering of $200 million in common stock and pre-funded warrants, subject to market conditions. The underwriters include major banks such as Goldman Sachs and J.P. Morgan. This move is part of their strategy to secure funding for their biotherapeutics aimed at addressing neurodegenerative diseases. However, the uncertainty of market conditions may impact the actual outcome of the offering.
Read more →DNLI▲ +5.8%on this newsshared move
Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement
Denali Therapeutics has entered into a $275 million royalty funding agreement with Royalty Pharma focusing on future sales of its investigational enzyme replacement therapy, tividenofusp alfa, for Hunter syndrome. The agreement is pending U.S. FDA accelerated approval due in April 2026, which is crucial for the transaction's activation. This funding will assist Denali in further development programs, promising advancements in the treatment of cognitive and physical challenges associated with Hunter syndrome.
Read more →DNLIDenali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights
Denali Therapeutics reported its Q3 2025 financial results, highlighting a net loss of $126.9 million. The company is gearing up for the launch of tividenofusp alfa and has submitted regulatory applications for clinical studies in Alzheimer's and Pompe diseases. Additionally, Denali's pipeline continues to expand with multiple promising therapies under development.
Read more →DNLIDenali Therapeutics Announces Board and Executive Leadership Updates
Denali Therapeutics has announced significant updates to its leadership team, including the appointment of Tim Van Hauwermeiren to the Board of Directors and the transition of Peter Chin to Acting Chief Medical Officer. Carole Ho will be leaving to join Eli Lilly as Executive Vice President. The changes come as Denali prepares for the potential commercialization of its first product, tividenofusp alfa.
Read more →DNLIDenali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)
Denali Therapeutics announced an extension of the FDA review timeline for its Biologics License Application for tividenofusp alfa, aimed at treating Hunter syndrome. The new Prescription Drug User Fee Act target date is now April 5, 2026. This extension follows the submission of updated clinical pharmacology information but does not relate to efficacy or safety concerns. Denali remains optimistic about the approval process and its commitment to the MPS community.
Read more →About Denali Therapeutics Inc.
Headquarters161 OYSTER POINT BLVD., SOUTH SAN FRANCISCO, CA, 94080
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