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Denali Therapeutics Inc.

$25.68

-1.4 (-5.15%)

C 47Pipeline Score Overvalued Biotech · Commercial
Market Cap
2.96 B
EPS
-2.88
P/E Ratio
-
Value Trade
19.98 M
SEC Financials
Q1 2026
  • Dilution Risk

    15%
  • R&D Expenses

    103.85 M

  • Operating CF

    -131.20 M


  • Total Assets

    1.27 B

  • Total Liabilities

    339.93 M

  • Equity

    926.10 M

  • D/E Ratio

    12,345

-1.95 %
Week
-8.09 %
1 Month
-6.8 %
3 Month
10.1 %
6 Month
-68.78 %
5 Year
-13.5 %
All Time
Cash Data
Stable
  • Cash Position

    987.68 M

  • Monthly Burn

    43.73 M

  • Runway

    20.7 mo

  • Burn Trend

    Accelerating
  • SEC Filing

    May 7, 2026
Overview
Volume
1.40 M
52 Week Range
12.58 - 23.77
% held by Insiders
6.3 %
% held by Institutions
100.86 %
Enterprise Value
2.01 B
Total Shares
146.70 M
Short %
10.36 %
Float Shares
128.21 M
Company Description
HQ: 161 OYSTER POINT BLVD., SOUTH ...
Employees:507

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
BIIB122 / DNL151 LRRK2-associated Parkinson's disease (biomarker/safety PD population; participants previously in LUMA) — Phase 2a (DNLI-C-0009 / Beacon-type PD study)
Phase 2a

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Small Molecules
Nervous System
BIIB122 / DNL151 LRRK2-associated Parkinson's disease (biomarker/safety PD population; participants previously in LUMA) — Phase 2a (DNLI-C-0009 / Beacon-type PD study)
Phase 2a

Subscribe to access the data.

Small Molecules
Nervous System
BIIB122 / DNL151 LRRK2-associated Parkinson's disease (biomarker/safety PD population; participants previously in LUMA) — Phase 2a (DNLI-C-0009 / Beacon-type PD study)
Phase 2a

Subscribe to access the data.

Small Molecules
Nervous System
Unlock Upcoming Catalyst data

Catalyst Timeline

Dated clinical, regulatory & corporate events for Denali Therapeutics Inc.

694Total events
18Upcoming
150Tier-1 (high impact)
2017 – 2029Coverage

Upcoming catalysts 18

Jul 12, 2026
T2Oral Presentation
Opening plenary address at AAIC 2026
Alzheimer's disease
Jul 28, 2026
T2Oral Presentation
BTIG Virtual Biotechnology Conference
Dec 2026
T1Topline Readout
Topline results from ongoing Phase 1/2 study expected by end of 2026
DNL593frontotemporal dementia-granulin (FTD-GRN)Phase 1/2
2026
T2Trial Initiation
Phase 3 study initiation expected in 2H 2026
DNL126Sanfilippo syndrome Type A (MPS IIIA)Phase 3
2026
T1Topline Readout
Initial FTD-GRN patient data expected in 2026
DNL593GRN-related frontotemporal dementia (FTD-GRN)Phase 1/2
Q1 2027
T1Topline Readout
Phase 2a BEACON study data anticipated in first half of 2027
BIIB122Parkinson's disease in LRRK2 pathogenic variant carriersPhase 2a
2027
T1BLA Submission
BLA submission and potential accelerated approval for DNL126 expected in 2027
DNL126Sanfilippo syndrome type A (MPS IIIA)Phase 1/2
2027
T1FDA Approval
Potential accelerated approval for DNL126 in 2027
DNL126Sanfilippo syndrome type A (MPS IIIA)
2027
T1Topline Readout
Clinical safety and biomarker proof-of-concept data expected
DNL628Alzheimer's diseasePhase 1b
2027
T1Topline Readout
Clinical safety and biomarker proof-of-concept data expected
DNL921Alzheimer's diseasePhase 1/1b
Dec 31, 2029
T1EU Approval
EMA approval milestone for additional payment
tividenofusp alfaApprovedmucopolysaccharidosis type II (Hunter syndrome)
TBD
T2Oral Presentation
Detailed findings from LUMA study to be presented at upcoming scientific conference
BIIB122Parkinson's diseasePhase 2b
TBD
T2Trial Initiation
Phase 2/3 COMPASS study ongoing for tividenofusp alfa
tividenofusp alfaApprovedHunter syndrome (MPS II)Phase 2/3
TBD
T3Enrollment Update
Cohort B of COMPASS study currently enrolling
tividenofusp alfaApprovedHunter syndrome (MPS II)Phase 2/3
2026-H1
T1Topline Readout
Phase 2 results expected for eclitasertib
SAR443122Ulcerative colitisPhase 2
2027-H1
T1Topline Readout
Data from Phase 1b study of DNL628 expected in 1H 2027
DNL628Alzheimer's diseasePhase 1b
2026-H1
T2IND Submission
Regulatory filing for DNL921 expected in first half of 2026
DNL921Alzheimer's diseaseIND-enabling
TBD
T2Trial Initiation
Initiation of Phase 1/1b clinical trial expected pending CTA approval
DNL921Alzheimer's diseasePhase 1/1b

Event history 676

Jun 18, 2026
PRV SoldDesignation
Denali sells Rare Pediatric Disease Priority Review Voucher for $195 million
Jun 8, 2026
Oral PresentationPresentation
Goldman Sachs 47th Annual Global Healthcare Conference
Jun 2, 2026
Oral PresentationPresentation
Jefferies Global Healthcare Conference
Jun 2026
FDA Approvaltividenofusp alfaApprovedFDA Decision
US accelerated approval expected in 1H 2026
Hunter syndrome (MPS II)source ↗
Jun 2026
Product Launchtividenofusp alfaApprovedPost-Market
Commercial launch of tividenofusp alfa in anticipation of FDA approval
Hunter syndrome (MPS II)source ↗
Jun 2026
Topline ReadoutDNL126Clinical Data
Phase 1/2 data expected in 1H 2026
Sanfilippo syndrome Type A (MPS IIIA)source ↗
Jun 2026
Trial InitiationDNL628Trial
Phase 1b study initiation expected in 1H 2026
Alzheimer's diseasesource ↗
Jun 2026
Trial InitiationDNL952Trial
Phase 1 study initiation expected in 1H 2026
Pompe diseasesource ↗
Jun 2026
Topline ReadoutBIIB122Clinical Data
Phase 2b LUMA data expected in 1H 2026
Parkinson's diseasesource ↗
Jun 2026
Topline ReadoutSAR443122Clinical Data
Phase 2 results expected in first half of 2026
ulcerative colitissource ↗
Jun 2026
Trial InitiationDNL921Trial
Phase 1/1b study initiation expected in 1H 2026
Alzheimer's diseasesource ↗
May 21, 2026
Topline ReadoutBIIB122Clinical Data
Phase 2b LUMA study topline results: did not meet primary or secondary endpoints
Early-stage Parkinson's diseasesource ↗
Drug Pipeline Intelligence
C47
Pipeline Score
$461M
Pipeline Value
Overvalued
Valuation Signal
11
Drugs Scored
0.2x
rNPV / MCap
Top 71%
Small Cap
(rank 265 of 911)
Percentile Rank
Denali Therapeutics Inc. carries a moderate pipeline score (47/100), with $712M risk-adjusted pipeline value, led by DNL919 in Healthy Participant (Phase 1).
Showing 1 of 1 assets
DrugIndicationPhaseNCT IDPTRSrNPVStatusEnrollmentVelocityDesignCompletionML SignalLast Change
DNL919
Small molecule
Healthy ParticipantPhase 1NCT054505497% $157M COMPLETED 47 - -Jun 8, 2023 -Aug 16, 2023
Unlock Drug Pipeline Intelligence
Clinical Trial Results
Drug Name Indications 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 o

Read More
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 o

Read More
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 o

Read More
Unlock Clinical Trial Results data
Inside Trades
TREND
CORPORATE INSIDERS BOUGHT SHARES WORTH 1.8M IN THE LAST 3 MONTHS
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLD
INSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Unlock Inside Trades data
Hedge Funds
TREND
HEDGE FUNDS INCREASED HOLDINGS BY 200.0K SHARES IN THE LAST QUARTER
Shares Held
2040.00B1530.00B1020.00B510.00B0
Q3
2024
Q4
2024
Q1
2025
Q2
2025
HEDGE FUNDS
SOLD
HEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Fund Count
60%
Share Volume
25%
Conviction
15%
HedgeFund Name
( 3 )
% of Portfolio Current MV
-
Shares Owned
-
Activity
Avg Price $0

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K
Unlock Hedge Funds table data
DNLI Institutional Ownership Trends
Current Insider %
5.20%
+0.00%
Current Institutional %
62.40%
+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
ExpirationVolumeOpen InterestImplied Volatility CallsImplied Volatility Puts
CallsPutsPut-Call RatioCallsPutsPut-Call RatioIVOiWaIvVWaIvIVOiWaIvVWaIv
2026-07-170 0.00 0 0 - - - - - -
2026-07-170 0.00 0 0 - - - - - -
2026-07-170 0.00 0 0 - - - - - -
Unlock Option Chain Statistics data
Option Chain
CallsStrikePuts
Last PriceVolumeOpen InterestLast PriceVolumeOpen Interest
No data available
Unlock Option Chain data
Unlock Options Chart data
Open interest
0 600K 1.2M 1.8M Avg OI 1.00 M Open Interest
0 1 2 3 1.1 Put-Call Ratio
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
0 450K 900K 1.4M Avg OV 750.00 K Option Volume
0 1 2 3 0.95 Put-Call Ratio
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
DNLI
Jul 9, 2026
DNLIConferences/Events
▼ -5.1%today

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 →
DNLI
Jun 18, 2026
DNLIFDA Updates

Denali 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 →
DNLI
May 21, 2026
DNLIPhases

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 o

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 →
DNLI
May 7, 2026
DNLIFDA Updates

Denali 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
Apr 3, 2026
DNLIPhases
▼ -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 →
DNLI
Mar 25, 2026
DNLIFDA Updates

Denali 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 →
DNLI
Feb 26, 2026
DNLIGeneral

Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights Tividenofusp alfa (DNL310 ETV IDS) launch readiness established ahead of

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
Feb 5, 2026
DNLIPhases
▼ -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 →
DNLI
Feb 2, 2026
DNLIConferences/Events

Denali 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 →
DNLI
Jan 30, 2026
DNLIConferences/Events

Denali 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
Jan 6, 2026
DNLIFDA Updates
▲ +7.4%on this news

Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome Preparing for FDA approval and commercial launch of tividenofusp alfa,

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 →
DNLI
Dec 30, 2025
DNLIPhases

The 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
Dec 10, 2025
DNLIGeneral
▼ -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.

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DNLI
Dec 9, 2025
DNLIGeneral

Denali 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.

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DNLI
Dec 4, 2025
DNLIGeneral
▲ +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 →
DNLI
Nov 6, 2025
DNLIGeneral

Denali 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 →
DNLI
Nov 6, 2025
DNLIGeneral

Denali 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.

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DNLI
Oct 13, 2025
DNLIFDA Updates

Denali 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 →
DNLI
Aug 11, 2025
DNLIFDA Updates

Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of

Denali Therapeutics reported its second-quarter 2025 financial results and highlighted key business developments. The FDA accepted the Biologics License Application for tividenofusp alfa for Hunter syndrome for priority review, with a PDUFA action date set for January 5, 2026. Denali is also preparing for the commercial launch of this investigational therapy. Furthermore, the company is advancing its DNL126 program for Sanfilippo syndrome Type A with a favorable path toward accelerated approval.

Read more →
DNLI
Jul 7, 2025
DNLIFDA Updates

Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II) FDA assigns PDUFA target action date of

Denali Therapeutics has announced that the FDA has accepted its Biologics License Application for tividenofusp alfa, aimed at treating Hunter syndrome. The application has been granted Priority Review, with a PDUFA target action date set for January 5, 2026. This investigational therapy is designed to deliver the missing enzyme directly into the brain and body, which current treatments do not do. Apart from its potential role in treating Hunter syndrome, this approval marks a pivotal moment for Denali's TransportVehicle platform, indicating a broader ambition to tackle more lysosomal storage diseases.

Read more →
DNLI
May 6, 2025
DNLIFDA Updates

Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome

Denali Therapeutics reported its Q1 2025 financial results, highlighting the completion of the BLA submission for tividenofusp alfa, a potential treatment for Hunter syndrome. The company is preparing for a commercial launch in late 2025 or early 2026. Despite a net loss increase, Denali continues to advance its clinical programs and expand its manufacturing capabilities.

Read more →
DNLI
Apr 2, 2025
DNLIFDA Updates
▲ +11.8%on this news

Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FDA on DNL126 Through START Progra

Denali Therapeutics has initiated the rolling submission of a Biologics License Application (BLA) for accelerated approval of its therapy, tividenofusp alfa, aimed at treating Hunter syndrome. The company is working closely with the FDA’s Center for Drug Evaluation and Research to ensure alignment on necessary data and potential approval timelines. A commercial launch is anticipated as early as late 2025. In addition, ongoing collaboration under the START program is facilitating a promising development pathway for DNL126, which targets Sanfilippo syndrome.

Read more →
DNLI
Feb 27, 2025
DNLIGeneral

Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.

Denali Therapeutics has reported its financial results for the fourth quarter and full year of 2024, highlighting substantial advancements in its Enzyme Transport Vehicle (ETV) programs. The company is preparing for the potential launch of tividenofusp alfa, targeted for Hunters syndrome, with an application for accelerated approval due in early 2025. However, Denali faced increased net losses and a significant drop in collaboration revenue compared to the previous year. The firm aims to enhance its portfolio by advancing one to two programs into the clinic annually over the next three years.

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DNLI
Feb 6, 2025
DNLIPhases

Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa

Denali Therapeutics announced positive results from its Phase 1/2 study of tividenofusp alfa for Hunter syndrome, showing significant improvements in key biomarkers and clinical outcomes. The company plans to submit a biologics license application in early 2025, aiming for accelerated approval. The treatment was generally well tolerated, with manageable adverse events reported.

Read more →
DNLI
Jan 30, 2025
DNLIConferences/Events

Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™

Denali Therapeutics announced its participation in the 2025 WORLDSymposium, where it will present clinical results for its investigational therapy, tividenofusp alfa, aimed at treating Hunter syndrome (MPS II). The presentations will include an oral session on efficacy and safety, as well as several poster sessions. Denali's TransportVehicle platform is designed to enhance therapeutic delivery across the blood-brain barrier.

Read more →
DNLI
Jan 13, 2025
DNLIFDA Updates

Denali Therapeutics Announces Key Anticipated 2025 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases FDA Breakthrough Therapy Designation receive

Denali Therapeutics has announced significant milestones anticipated for 2025, including the submission of a biologics license application for tividenofusp alfa for Hunter syndrome, which has received FDA Breakthrough Therapy Designation. The company is also preparing for its commercial launch, slated for late 2025 or early 2026. Additionally, Denali plans to seek FDA alignment for accelerated approval of its DNL126 program for Sanfilippo syndrome and to advance its platform of TransportVehicleTM enabled therapies. Their portfolio expansion aims to provide treatment options for both neurodegenerative and lysosomal storage diseases.

Read more →
DNLI
Jan 8, 2025
DNLIFDA Updates

Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)

Denali Therapeutics announced that the U.S. FDA granted Breakthrough Therapy Designation to its investigational drug tividenofusp alfa (DNL310) for treating Hunter syndrome (MPS II). This designation adds to previous recognitions including Fast Track and Orphan Drug designations. The drug has shown promising results in early clinical studies, and Denali plans to submit a Biologics License Application in early 2025. The designation is aimed at expediting the development of therapies that have shown substantial improvement over existing treatments.

Read more →
DNLI
Jan 6, 2025
DNLIPhases
▼ -6.8%on this newsshared move

Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2 3 HEALEY ALS Platform Trial Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpo

Denali Therapeutics has announced topline results from the Phase 2 3 HEALEY ALS Platform Trial evaluating its eIF2B agonist DNL343. Unfortunately, the trial did not meet the primary endpoint of efficacy in slowing ALS disease progression, nor did it show statistical differences in key secondary measures such as muscle strength and respiratory function. Nonetheless, the drug was reported as safe and well tolerated, with further analyses on biomarkers and treatment extension forthcoming in 2025. This outcome highlights ongoing challenges in developing effective therapies for ALS.

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DNLI
Dec 5, 2024
DNLIPhases

Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson’s Disease

Denali Therapeutics has announced the commencement of dosing in its Phase 2a clinical study, named BEACON, which evaluates the safety and biomarkers of the LRRK2 inhibitor BIIB122 in participants with LRRK2-associated Parkinson's disease. This study aims to enroll approximately 50 participants and involves a double-blind treatment period followed by an open-label extension. Denali is leading the study's design and execution, with financial support from a third-party agreement. The findings from this study could provide important insights into the therapeutic potential of LRRK2 inhibition for Parkinson's disease.

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DNLI
Nov 6, 2024
DNLIGeneral
▲ +6.9%on this news

Denali Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.

Denali Therapeutics reported its third quarter 2024 financial results, highlighting significant progress in its clinical portfolio. The company is on track to submit a biologics license application for tividenofusp alfa in MPS II, aiming for accelerated approval in early 2025. Preliminary data from the DNL126 study in MPS IIIA has shown promising outcomes with reduced CSF heparan sulfate levels. However, the company also faced challenges, including increased net losses and the discontinuation of the K2 Phase 2 study for SAR443820 due to unmet efficacy endpoints.

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DNLI
Sep 3, 2024
DNLIFDA Updates

Denali Therapeutics Announces Successful Meeting with the FDA and Plans to File for Accelerated Approval of Tividenofusp Alfa (DNL310) for the Treatment of MPS II (Hunter Syndrome)

Denali Therapeutics announced a successful meeting with the FDA that paves the way for filing a biologics license application (BLA) for accelerated approval of tividenofusp alfa (DNL310) for the treatment of MPS II. The company plans to submit the BLA in early 2025, supported by preclinical and clinical data demonstrating favorable biomarkers. New Phase 1/2 data will be presented at the SSIEM conference, showcasing significant reductions in disease biomarkers and improvements in clinical outcomes. Tividenofusp alfa's safety profile appears robust, indicating its potential as a therapy for this rare genetic condition.

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DNLI
Aug 14, 2024
DNLIGeneral

Denali Therapeutics Announces Publication in Science Translational Medicine Demonstrating the Potential of the Oligonucleotide Transport Vehicle Platform to Achieve Broad Biodistribution of Antisense Oligonucleotides in the CNS and Muscle Following Intravenous Administration

Denali Therapeutics announced the publication of nonclinical data in 'Science Translational Medicine' that highlights the effectiveness of their Oligonucleotide Transport Vehicle (OTV) platform. The study reveals that OTV can deliver antisense oligonucleotides to achieve broad biodistribution in the central nervous system and muscle following intravenous administration. This represents a significant advancement in addressing the challenges posed by the blood-brain barrier in drug delivery, supporting future development of treatments for Alzheimer's and Parkinson's diseases.

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DNLI
Aug 1, 2024
DNLIGeneral

Denali Therapeutics Reports Second Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.

Denali Therapeutics reported its financial results for the second quarter of 2024, highlighting key business developments in neurodegenerative disease treatments. The company is engaged with the FDA on accelerated approval pathways for several product candidates and regained rights to its ATV Abeta program from Biogen. However, it faced a net loss of $99 million in the quarter, a sharp decline in revenue compared to the previous year due to the absence of collaboration revenue. The ongoing engagement in clinical trials and strong pipeline activity indicates potential future growth despite current financial challenges.

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DNLI
Jun 3, 2024
DNLIFDA Updates
▲ +9.8%on this news

Denali Therapeutics Announces FDA Has Selected DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo Syndrome Type A) for START Pilot Program Intended to Accelerate Development of Rare Disease Therapies

Denali Therapeutics has announced that the FDA has selected its investigational enzyme replacement therapy, DNL126, for the START Pilot Program aimed at accelerating the development of therapies for rare diseases like MPS IIIA. This selection is significant as it allows for more rapid communication with FDA staff and is intended to streamline development processes. Denali is actively conducting a Phase 1/2 study of DNL126, addressing the urgent needs of patients with Sanfilippo syndrome Type A, a condition currently lacking approved treatments.

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DNLI
May 7, 2024
DNLIGeneral

Denali Therapeutics Reports First Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.

Denali Therapeutics reported its financial results for the first quarter of 2024, showcasing advancements in its clinical portfolio. The company highlighted positive two-year clinical data for its enzyme replacement therapy tividenofusp alfa in MPS II and announced the initiation of a clinical trial for another therapy, DNL126, aimed at MPS IIIA. However, the financial data revealed a net loss of $101.8 million and a lack of collaboration revenue, combined with the discontinuation of specific treatment programs. Despite these challenges, Denali remains optimistic about future opportunities in neurodegenerative disease therapeutics.

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DNLI
May 1, 2024
DNLIPhases

Denali Therapeutics Announces Completion of Enrollment for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial

Denali Therapeutics has announced the successful completion of enrollment for Regimen G in the Phase 2/3 HEALEY ALS Platform Trial, which evaluates its investigational therapy DNL343. The trial seeks to assess the therapeutic effects of this eIF2B agonist, a candidate designed to address mechanisms of neurodegeneration in ALS. While the completion of enrollment is a crucial milestone, the company acknowledges ongoing risks associated with clinical trials and the potential for adverse effects. This latest advancement signifies potential progress in developing effective ALS treatments.

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DNLI
Feb 27, 2024
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▲ +38.2%on this news

Denali Therapeutics Announces $500 million Private Placement Equity Financing

Denali Therapeutics announced a $500 million private placement equity financing aimed at enhancing its product development efforts. This funding will support the research and expansion of its proprietary technology designed to facilitate drug delivery across the blood-brain barrier. The transaction is scheduled to close by February 29, 2024, pending customary conditions. Proceeds from this financing are intended for ongoing research activities and general corporate needs, with expectations of reaching approximately $1.5 billion in cash reserves thereafter.

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DNLI
Feb 27, 2024
DNLIGeneral
▲ +38.2%on this news

Denali Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.

Denali Therapeutics announced its financial results for Q4 and the full year 2023, highlighting significant progress in its portfolio, particularly in late-stage trials for MPS II and ALS. They reported net losses of $119.5 million for the quarter, up from $98.7 million a year earlier. A PIPE financing effort has raised around $500 million, expected to sustain operations through 2028. Despite challenges such as the underperformance of the HIMALAYA study, Denali continues to advance its innovative therapies targeting neurodegenerative diseases.

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DNLI
Feb 7, 2024
DNLIPhases

Denali Therapeutics Announces New Data and Expansion of Its Blood-Brain Barrier (BBB)-Crossing Enzyme Replacement Therapy Programs at WORLDSymposium™

Denali Therapeutics announced promising new data at the WORLDSymposium™ regarding their enzyme replacement therapies targeting mucopolysaccharidoses. Notable findings include substantial clinical improvements in patients with MPS II after 104 weeks of tividenofusp alfa treatment and progress in the initiation of Phase 1/2 dosing for DNL126 targeting MPS IIIA. The data highlighted sustained reductions in biomarkers and suggestions of cognitive improvements in mouse models, showcasing the potential impacts of Denali’s therapies on both brain and physical symptoms. The company aims for rapid development and collaboration with the MPS community to expedite treatment access.

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DNLI
Feb 1, 2024
DNLIConferences/Events

Denali Therapeutics Announces Presentations on Its Investigational Blood-Brain Barrier (BBB)-Crossing Enzyme Replacement Therapies at the Upcoming 2024 WORLDSymposium™

Denali Therapeutics announced it will present data on its investigational enzyme replacement therapies, DNL310 and DNL126, at the upcoming 2024 WORLDSymposium™. The presentations will showcase new two-year clinical outcomes for DNL310 and preclinical studies for DNL126. These therapies are designed to cross the blood-brain barrier, addressing symptoms of neurodegenerative diseases and lysosomal storage disorders. The symposium will take place from February 4-9, 2024, in San Diego, California.

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DNLI
Jan 8, 2024
DNLIPhases
▲ +5.3%on this news

Denali Therapeutics Announces Key Anticipated 2024 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases Complete enrollment in Denali-led, late-stag

Denali Therapeutics has announced significant progress and anticipated milestones for 2024, focusing on their therapeutic portfolio targeting neurodegenerative and lysosomal storage diseases. Key developments include the completion of enrollment in late-stage clinical trials for MPS II and ALS, as well as the initiation of several new programs utilizing their Enzyme Transport Vehicle technology. Despite positive clinical outcomes, there has been a temporary pause in the DNL593 study due to infusion-related reactions in participants. Overall, Denali aims to maintain momentum in advancing its innovative therapies.

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DNLI
Nov 7, 2023
DNLIGeneral

Denali Therapeutics Reports Third Quarter 2023 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.

Denali Therapeutics reported its third quarter financial results, highlighting advancements in its therapeutic portfolio for neurodegenerative and lysosomal storage diseases. The company noted promising interim data for DNL310 in MPS II, showing positive biomarker outcomes and good tolerability. Despite these advancements, Denali faced a net loss of $99.4 million, with collaboration revenues decreasing from the previous year. The company is also adjusting its 2023 operating expense guidance downward amid ongoing clinical developments.

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DNLI
Aug 30, 2023
DNLIPhases

Denali Therapeutics Announces New Interim Data from Phase 1/2 Study of DNL310 (ETV:IDS) in MPS II (Hunter Syndrome) at SSIEM 2023

Denali Therapeutics revealed promising interim data from its Phase 1/2 study of DNL310 for MPS II (Hunter syndrome) at the SSIEM Annual Symposium 2023. The data showcased normalization of key biomarkers and improvements in cognitive functions over a two-year period. DNL310 is a novel enzyme replacement therapy engineered to penetrate the blood-brain barrier, addressing both physical and neurocognitive symptoms of MPS II. The ongoing recruitment for the Phase 2/3 COMPASS study aims to further assess DNL310's efficacy and potential in treating this genetic disorder.

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DNLI
Aug 8, 2023
DNLIGeneral

Denali Therapeutics Reports Second Quarter 2023 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.

Denali Therapeutics reported its financial results for Q2 2023, highlighting significant advancements in several clinical programs, particularly DNL310 for MPS II. The company demonstrated promising data with a considerable decline in neurofilament light levels, supporting ongoing studies. Additionally, Denali and Biogen progressed in their partnership, though they decided to discontinue the development of TAK-920 DNL919 for Alzheimer's disease. Despite the setbacks in certain areas, Denali aims to optimize its resources and focus on late-stage programs.

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DNLI
Jun 20, 2023
DNLIPhases

Denali Therapeutics Announces Robust Reduction in Neurofilament Light (NfL) with DNL310 (ETV IDS) Treatment in MPS II (Hunter Syndrome) Interim results demonstrate average reduction of 64% (p 0.001) from baseline in seru

Denali Therapeutics has released promising interim results from its Phase 1/2 study of DNL310, showing a 64% reduction in neurofilament light (NfL) levels in participants with MPS II after two years of dosing. The FDA has endorsed the assessment of NfL as a potential biomarker for understanding the disease's progression and treatment response. Additional data is expected to be presented at the upcoming SSIEM symposium. DNL310 is an investigational therapy aimed at addressing both cognitive and physical symptoms linked to MPS II.

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DNLI
May 8, 2023
DNLIGeneral

Denali Therapeutics Reports First Quarter 2023 Financial Results and Business Highlights

Denali Therapeutics Inc. reported its financial results for Q1 2023 and provided updates on its clinical programs. The company highlighted advancements in several late-stage therapies, including positive interim data for DNL310 in treating MPS II, which showed beneficial changes in cognitive and behavioral outcomes. Furthermore, Denali presented promising safety and biomarker data for the DNL343 study in ALS and highlighted ongoing recruitment for various other clinical trials. Overall, the updates reflect a strong momentum in Denali's efforts to address neurodegenerative diseases.

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DNLI
Apr 10, 2023
DNLIPhases

Denali Therapeutics Announces New DNL343 (eIF2B Agonist) Phase 1b Data in ALS To Be Presented at the Upcoming AAN Annual Meeting

Data show that DNL343 is generally well-tolerated at doses that demonstrate robust inhibition of biomarkers associated with the integrated stress response (ISR) Clinical pharmacokinetic and ISR pharmacodynamic data, along with preclinical data, are consistent with extensive CNS

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DNLI
Feb 27, 2023
DNLIGeneral

Denali Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights

Denali Therapeutics Inc. reported its fourth quarter and full year 2022 financial results, highlighting significant progress in late-stage clinical development for various neurodegenerative and lysosomal storage diseases. The company's Therapeutic portfolio has expanded, with promising interim data from studies on investigational therapies like DNL310 for MPS II and DNL593 for FTD-GRN. Denali’s financial position remains strong, with $1.34 billion in cash and equivalents at the end of 2022, supporting its ongoing research efforts and clinical trials.

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DNLI
Feb 22, 2023
DNLIPhases

Denali Therapeutics Announces New Interim Data from DNL310 Phase 1/2 Study for MPS II and DNL126 Preclinical Data for MPS IIIA at WORLDSymposium™

Over 49 weeks of DNL310 (ETV:IDS) treatment in the Phase 1/2 study, positive changes across measures of exploratory clinical outcomes including VABS-II (adaptive behavior) and BSID-III (cognitive capabilities) scores and global impression scales were observed Interim Phase 1/2 d

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DNLI
Feb 15, 2023
DNLIConferences/Events

Denali Therapeutics Announces Presentations on Enzyme Transport Vehicle (ETV) Development Programs for MPS Diseases at the Upcoming WORLDSymposium™

SOUTH SAN FRANCISCO, Calif., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and l

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DNLI
Jan 25, 2023
DNLIPhases

Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in Multiple Sclerosis by Sanofi

Partner Sanofi has commenced dosing in a Phase 2 clinical trial of SAR443820 (DNL788) in individuals with multiple sclerosis Denali to receive a milestone payment of $25 million from Sanofi for Phase 2 clinical trial initiation Development of RIPK1 inhibitor program continues i

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DNLI
Jan 9, 2023
DNLIPhases

Denali Therapeutics Announces Key Anticipated 2023 Milestones for Its Therapeutic Portfolio for Neurodegeneration and Lysosomal Storage Diseases Four programs expected to progress in late-stage clinical studies for MPS I

Denali Therapeutics has outlined its key milestones for 2023, highlighting the anticipated progression of four therapeutic programs into late-stage clinical studies, targeting MPS II, ALS, and Parkinson's disease. The company is leveraging its proprietary Transport Vehicle technology to enhance drug delivery across the blood-brain barrier. Additional developments in Denali's early-stage pipeline are also underway, with expected interim data readouts from ongoing studies planned throughout the year. CEO Ryan Watts emphasized the company's commitment to address significant unmet needs in neurodegenerative and lysosomal storage diseases with their innovative programs.

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DNLI
Dec 5, 2022
DNLIPhases
▼ -5.2%on this news

Denali Therapeutics Announces DNL343 Interim Phase 1b Data in ALS and Entry into the HEALEY ALS Platform Trial

DNL343 demonstrated extensive blood-brain barrier penetration and robustly inhibited the integrated stress response pathway implicated in ALS Once-daily oral dosing with DNL343 for 28 days was generally well tolerated in participants with ALS The design phase for entry of DNL34

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DNLI
Nov 3, 2022
DNLIGeneral

Denali Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights

Denali Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights SOUTH SAN FRANCISCO - November 3, 2022 - Denali Therapeutics Inc. (Nasdaq DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-

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DNLI
Nov 1, 2022
DNLIPhases

Denali Therapeutics Announces Phase 1/2 Study Single Dose Healthy Volunteer Data with TAK-594/DNL593 (PTV:PGRN) and Progression to Enrolling Participants with FTD-GRN

Interim results from Part A in healthy volunteers demonstrated dose-dependent increases in CSF progranulin levels, consistent with robust brain delivery of DNL593 Single doses of DNL593 were generally well tolerated Data support progression to enrolling participants with FTD-GR

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DNLI
Oct 24, 2022
DNLIGeneral

Denali Therapeutics Announces Closing of a $316 Million Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

SOUTH SAN FRANCISCO, Calif., Oct. 24, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the closing of its upsized underwritten public offering of 11,933,962 shares of its common stock at a price to the public of $26.50 per share, which includes the

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DNLI
Oct 19, 2022
DNLIGeneral
▼ -15.1%on this newsshared move

Denali Therapeutics Announces Pricing of $275 Million Public Offering of Common Stock

Denali Therapeutics Announces Pricing of $275 Million Public Offering of Common Stock SOUTH SAN FRANCISCO, CA - Oct. 19, 2022 - Denali Therapeutics Inc. (NASDAQ DNLI) today announced the pricing of its underwritten public offering of 10,377,359 shares of its common stock at a pr

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DNLI
Oct 18, 2022
DNLIGeneral

Denali Therapeutics Announces Proposed Offering of Common Stock

Denali Therapeutics Announces Proposed Offering of Common Stock SOUTH SAN FRANCISCO, Calif. - Oct. 18, 2022 - Denali Therapeutics Inc. (NASDAQ DNLI) today announced that it intends to offer and sell $250 million of shares of its common stock in an underwritten public offering. I

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DNLI
Aug 31, 2022
DNLIPhases

Denali Therapeutics Announces New Interim Data from Phase 1/2 Study of DNL310 (ETV:IDS) in MPS II (Hunter Syndrome) at SSIEM 2022

Additional one-year data continue to show rapid and sustained normalization to healthy levels of CSF heparan sulfate and improvements in biomarkers of lysosomal function consistent with durable central nervous system activity Safety profile, now with up to 85 weeks of dosing, co

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DNLI
Aug 8, 2022
DNLIGeneral

Denali Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights

Denali Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights SOUTH SAN FRANCISCO - August 8, 2022 - Denali Therapeutics Inc. (Nasdaq DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-b

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DNLI
May 31, 2022
DNLIPhases

Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease

BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s disease Phase 2b LUMA to enroll approximately 640 participants with early-stage Parkinson’s disease; most advanced clinical study of a LRR

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DNLI
May 5, 2022
DNLIGeneral
▼ -10.3%on this news

Denali Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights

Denali Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights SOUTH SAN FRANCISCO - May 5, 2022 - Denali Therapeutics Inc. (Nasdaq DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain

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DNLI
May 2, 2022
DNLIPhases
▲ +5.7%on this newsshared move

Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in ALS by Sanofi

Partner Sanofi has commenced dosing in a Phase 2 clinical trial of SAR443820 (DNL788) in individuals with amyotrophic lateral sclerosis (ALS) Denali to receive a milestone payment of $40 million from Sanofi for Phase 2 clinical trial initiation Development of RIPK1 inhibitor pr

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DNLI
Mar 15, 2022
DNLIGeneral

Denali Therapeutics Appoints Alexander Schuth as Chief Operating and Financial Officer as Steve Krognes Transitions to Denali Board of Directors

Denali Therapeutics Appoints Alexander Schuth as Chief Operating and Financial Officer as Steve Krognes Transitions to Denali Board of Directors SOUTH SAN FRANCISCO, Calif., March 15, 2022 Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad

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DNLI
Mar 9, 2022
DNLIPhases
▲ +8.2%on this news

Denali Therapeutics Announces Initiation of Phase 1/2 Clinical Trial of DNL593 (PTV:PGRN) for Frontotemporal Dementia-Granulin (FTD-GRN)

SOUTH SAN FRANCISCO, Calif., March 09, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announce

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DNLI
Feb 28, 2022
DNLIGeneral

Denali Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights

Denali Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights SOUTH SAN FRANCISCO - February 28, 2022 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to

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DNLI
Feb 10, 2022
DNLIPhases
▼ -5.4%on this news

Denali Therapeutics Announces Continued Progress in DNL310 (ETV IDS) Program for MPS II (Hunter Syndrome) Supporting Planned Initiation of Phase 2 3 Clinical Trial Longer-term data in 20 patients show sustained normaliza

Denali Therapeutics Announces Continued Progress in DNL310 (ETV IDS) Program for MPS II (Hunter Syndrome) Supporting Planned Initiation of Phase 2 3 Clinical Trial Longer-term data in 20 patients show sustained normalization to healthy levels of CSF heparan sulfate and improveme

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DNLI
Feb 7, 2022
DNLIGeneral
▲ +6.2%on this newsshared move

Denali Therapeutics Announces Appointment of Erik Harris to Board of Directors

Denali Therapeutics Announces Appointment of Erik Harris to Board of Directors SOUTH SAN FRANCISCO, Calif., February 7, 2022 -- Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-br

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DNLI
Feb 1, 2022
DNLIConferences/Events

Denali Therapeutics Announces Presentations on DNL310 (ETV:IDS) Development Program in MPS II (Hunter Syndrome) at the Upcoming WORLDSymposium™

SOUTH SAN FRANCISCO, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced

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DNLI
Jan 13, 2022
DNLIFDA Updates
▼ -12.2%on this news

Denali Therapeutics Announces FDA Clinical Hold on DNL919 Investigational New Drug (IND) Application

SOUTH SAN FRANCISCO, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced

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DNLI
Jan 10, 2022
DNLIPhases

Denali Therapeutics Announces Progression and Expansion of Broad Therapeutic Portfolio for Neurodegeneration and Expected Key Milestones in 2022 Key data readouts to include additional Phase 1 2 data on DNL310 (ETV IDS)

Denali Therapeutics Announces Progression and Expansion of Broad Therapeutic Portfolio for Neurodegeneration and Expected Key Milestones in 2022 Key data readouts to include additional Phase 1 2 data on DNL310 (ETV IDS) in MPS II (Hunter syndrome) and the first clinical data on

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DNLI
Nov 17, 2021
DNLIGeneral

Denali Therapeutics Announces Strategic Partner Takeda Exercises Option to Co-Develop and Co-Commercialize DNL593 (PTV PGRN) - Companies to advance clinical development of DNL593 as a brain-penetrant progranulin replacem

Denali Therapeutics Announces Strategic Partner Takeda Exercises Option to Co-Develop and Co-Commercialize DNL593 (PTV PGRN) - Companies to advance clinical development of DNL593 as a brain-penetrant progranulin replacement therapy for frontotemporal dementia-granulin (FTD-GRN)

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DNLI
Nov 4, 2021
DNLIGeneral

Denali Therapeutics Reports Third Quarter 2021 Financial Results and Business Highlights

Denali Therapeutics Reports Third Quarter 2021 Financial Results and Business Highlights SOUTH SAN FRANCISCO - November 4, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-

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DNLI
Oct 6, 2021
DNLIGeneral

Denali Therapeutics Announces Positive Clinical Results and Regulatory Progress for Development Programs in Amyotrophic Lateral Sclerosis (ALS)

eIF2B activator DNL343 achieved safety and biomarker goals in a Phase 1 study in healthy volunteers; a Phase 1b study began in individuals with ALS in Q3 2021 Fast Track designation granted by the U.S. Food and Drug Administration (FDA) to SAR443820/DNL788, a RIPK1 inhibitor, fo

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DNLI
Sep 29, 2021
DNLIConferences/Events

Denali Therapeutics Announces Upcoming Presentations on EIF2B Activator DNL343 and RIPK1 Inhibitor SAR443820/DNL788 at the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting

Denali to present results from Phase 1 healthy volunteer study of EIF2B activator DNL343 Sanofi to present Phase 2 study plans in ALS for RIPK1 inhibitor SAR443820 Denali to host analyst and investor webinar on October 6, at 4:30 p.m. Eastern Time SOUTH SAN FRANCISCO, Calif.,

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DNLI
Sep 27, 2021
DNLIGeneral

Denali Therapeutics Appoints Katie Peng as Chief Commercial Officer

SOUTH SAN FRANCISCO, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announce

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DNLI
Sep 9, 2021
DNLIPhases

Denali Therapeutics Announces Initiation of Phase 1b Study of EIF2B Activator DNL343 in ALS

SOUTH SAN FRANCISCO, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announce

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DNLI
Aug 26, 2021
DNLIGeneral

Denali Therapeutics Announces Publication in Cell on New Approach to Treat FTD-GRN

SOUTH SAN FRANCISCO, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced

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DNLI
Aug 4, 2021
DNLIGeneral

Denali Therapeutics Reports Second Quarter 2021 Financial Results and Business Highlights

Denali Therapeutics Reports Second Quarter 2021 Financial Results and Business Highlights SOUTH SAN FRANCISCO - August 4, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-b

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DNLI
Jul 25, 2021
DNLIPhases
▼ -15.3%on this news

Denali Therapeutics Announces Positive Interim Data from Phase 1 2 Study with ETV IDS (DNL310) in Patients with the Lysosomal Storage Disease Hunter Syndrome (MPS II) Rapid reduction and sustained normalization of hepara

Denali Therapeutics Announces Positive Interim Data from Phase 1 2 Study with ETV IDS (DNL310) in Patients with the Lysosomal Storage Disease Hunter Syndrome (MPS II) Rapid reduction and sustained normalization of heparan sulfate in CSF demonstrated robust and durable CNS activi

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DNLI
Jul 15, 2021
DNLIPhases

Denali Therapeutics to Present Interim Data from Phase 1/2 Study of ETV:IDS (DNL310) for the Potential Treatment of Hunter Syndrome at MPS 2021

SOUTH SAN FRANCISCO, Calif., July 15, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced

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DNLI
Jun 28, 2021
DNLIPhases

Denali Therapeutics Announces Initiation of Phase 2 Study by Partner Sanofi of RIPK1-Inhibitor DNL758 (SAR443122) in Cutaneous Lupus Erythematosus (CLE) Patients

SOUTH SAN FRANCISCO, Calif., June 28, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced

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DNLI
May 3, 2021
DNLIGeneral

Denali Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights

Denali Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights SOUTH SAN FRANCISCO - May 3, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain

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DNLI
May 1, 2021
DNLIPhases

Denali Therapeutics Presents Positive Results from Phase 1 and Phase 1b Studies of Its LRRK2 Inhibitor, BIIB122/DNL151, Supporting Late-Stage Development Plans in Parkinson’s Disease

Treatment with BIIB122/DNL151 achieved robust reductions in biomarkers of target engagement and pathway engagement in healthy volunteers and patients with Parkinson’s disease BIIB122/DNL151 demonstrated a safety profile supporting continued development in patients with Parkinson

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DNLI
Mar 11, 2021
DNLIFDA Updates

Denali Therapeutics Announces Fast Track Designation Granted by the U.S. FDA to ETV:IDS (DNL310) for the Treatment of Patients with Hunter Syndrome (MPS II)

SOUTH SAN FRANCISCO, Calif., March 11, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announce

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DNLI
Feb 25, 2021
DNLIGeneral

Denali Therapeutics Reports Full Year 2020 Financial Results and Business Highlights

Denali Therapeutics Reports Full Year 2020 Financial Results and Business Highlights SOUTH SAN FRANCISCO - February 25, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-bra

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DNLI
Feb 12, 2021
DNLIPhases

Denali Therapeutics Reports Positive Three-Month Data from Phase 1 2 Study with ETV IDS (DNL310) in Patients with Hunter Syndrome (MPS II) Sustained normalization and further decreased levels of CSF glycosaminoglycan hep

Denali Therapeutics Reports Positive Three-Month Data from Phase 1 2 Study with ETV IDS (DNL310) in Patients with Hunter Syndrome (MPS II) Sustained normalization and further decreased levels of CSF glycosaminoglycan heparan sulfate, a key CNS disease biomarker, observed after t

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DNLI
Feb 5, 2021
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IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE JOHN SOLAK, derivatively on behalf of DENALI THERAPEUTICS, INC., Plaintiff, v. VICKI L. SATO, Ph.D., RYAN J. WATTS, Ph.D., DOUGLAS G. COLE, M.D., JENNIFER COOK, JAY FLATL

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE NOTICE OF PENDENCY OF SETTLEMENT OF ACTION TO: ALL CURRENT STOCKHOLDERS OF DENALI THERAPEUTICS INC. (TRADING SYMBOL: DNLI) THIS NOTICE CAREFULLY AND IN ITS ENTIRETY. YOUR RIGHTS WILL BE AFFECTED BY THE LEGAL PROCEEDINGS IN THI

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DNLI
Feb 5, 2021
DNLIConferences/Events

Denali Therapeutics to Present New Data on ETV:IDS (DNL310) for the Potential Treatment of Hunter Syndrome at WORLDSymposium™

SOUTH SAN FRANCISCO, Calif., Feb. 05, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced

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DNLI
Jan 11, 2021
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Denali Therapeutics Announces Appointment of Nancy Thornberry to Board of Directors

Denali Therapeutics Announces Appointment of Nancy Thornberry to Board of Directors SOUTH SAN FRANCISCO, Calif., January 11, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the bloo

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DNLI
Jan 8, 2021
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Denali Therapeutics Announces Significant Program Progress and Expected Key Milestones in 2021 for Its Broad Therapeutic Portfolio in Neurodegeneration

Late-breaker presentation on 12-week data from Cohort A in Phase 1/2 study of DNL310 (ETV:IDS) in Hunter syndrome (MPS II) to be held at WORLD Symposium on February 12th Following previously announced data on CSF GAG reduction with DNL310 and achievement of biomarker proof-of-co

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DNLI
Nov 10, 2020
DNLIPhases

Denali Therapeutics Announces First Human Biomarker Proof of Concept for Its Transport Vehicle (TV) Technology Achieved in Phase 1 2 Study of ETV IDS (DNL310) in Hunter Syndrome (MPS II) After four weekly intravenous dos

Denali Therapeutics Announces First Human Biomarker Proof of Concept for Its Transport Vehicle (TV) Technology Achieved in Phase 1 2 Study of ETV IDS (DNL310) in Hunter Syndrome (MPS II) After four weekly intravenous doses of DNL310, a 76% mean reduction in CSF GAG levels (hepar

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DNLI
Nov 5, 2020
DNLIGeneral

Denali Therapeutics Reports Third Quarter 2020 Financial Results and Business Highlights

Denali Therapeutics Reports Third Quarter 2020 Financial Results and Business Highlights SOUTH SAN FRANCISCO - November 5, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-

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DNLI
Oct 15, 2020
DNLIConferences/Events

Denali Therapeutics to Highlight Progress Across Broad Biotherapeutics Portfolio for Neurodegeneration Enabled by Its Blood-Brain Barrier (BBB) TV Platform at Virtual R&D Day Today

Proprietary and differentiated Transport Vehicle (TV) technology shows potential to solve the BBB challenge by delivering biotherapeutics to the brain New preclinical data support the potential for systemic administration of ETV:IDS (DNL310) to treat the neurological pathology o

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DNLI
Oct 7, 2020
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Denali Therapeutics Announces Closing of Collaboration and Share Purchase Agreements with Biogen

Denali Therapeutics Announces Closing of Collaboration and Share Purchase Agreements with Biogen SOUTH SAN FRANCISCO, Calif., Oct 7, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross

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DNLI
Sep 30, 2020
DNLIConferences/Events

Denali Therapeutics to Host Webinar on Transporting Biotherapeutics Across the Blood-Brain Barrier

— Webinar scheduled for Thursday, October 15th at 1:00 p.m. Eastern Time — SOUTH SAN FRANCISCO, Sept. 30, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the bloo

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DNLI
Aug 7, 2020
DNLIGeneral

Denali Therapeutics Reports Second Quarter 2020 Financial Results and Business Highlights

Denali Therapeutics Reports Second Quarter 2020 Financial Results and Business Highlights SOUTH SAN FRANCISCO - August 7, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-b

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DNLI
Aug 6, 2020
DNLIGeneral

Denali Therapeutics Announces Decision to Advance DNL151 into Late Stage Clinical Studies in Parkinson’s Patients

DNL151 selected to advance into two late stage studies in Parkinson’s disease in patients with a kinase activating mutation in LRRK2 and in patients with sporadic disease Denali and collaboration partner Biogen are finalizing DNL151 clinical development plans and intend to comme

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DNLI
Aug 6, 2020
DNLIGeneral

BIOGEN AND DENALI TO COLLABORATE ON LRRK2 PROGRAM FOR PARKINSON'S DISEASE AND CERTAIN TV PLATFORM-ENABLED PROGRAMS FOR NEURODEGENERATIVE DISEASES Biogen to receive license to co-develop and co-commercialize Denali's smal

BIOGEN AND DENALI TO COLLABORATE ON LRRK2 PROGRAM FOR PARKINSON'S DISEASE AND CERTAIN TV PLATFORM-ENABLED PROGRAMS FOR NEURODEGENERATIVE DISEASES Biogen to receive license to co-develop and co-commercialize Denali's small molecule LRRK2 inhibitor program, expanding pipeline of p

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DNLI
Jul 29, 2020
DNLIPhases

Denali Therapeutics Announces Phase 1b Study by Partner Sanofi of RIPK1-Inhibitor DNL758 (SAR443122) in COVID-19 Patients

Dosing of DNL758 (SAR443122) has commenced in a randomized, double-blind, placebo-controlled Phase 1b trial to evaluate safety and effect on the immune system in severe COVID-19 DNL758, discovered by Denali and partnered with Sanofi, is a small molecule inhibitor of RIPK1 that d

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DNLI
Jun 9, 2020
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Denali Therapeutics Provides Broad Update on Its RIPK1 Program Partnered With Sanofi

Denali and Sanofi pause DNL747(a) clinical activities based on the totality of DNL747 data and a superior profile of backup compound DNL788(b) Denali and Sanofi intend to accelerate DNL788 for development in neurological indications, with plans to initiate clinical testing by ea

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DNLI
May 27, 2020
DNLIGeneral

Denali Therapeutics Announces Publication of Two New Papers Describing Its Blood-Brain Barrier Delivery Technology in Science Translational Medicine

Denali’s “Transport Vehicle” technology enables broad distribution and improved exposure levels of therapeutic proteins throughout the brain Clinical proof of concept data with DNL310 (ETV:IDS), the first product candidate enabled by the transport vehicle technology, are expecte

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DNLI
May 7, 2020
DNLIGeneral

Denali Therapeutics Reports First Quarter 2020 Financial Results and Provides COVID-19 Response Update

Denali Therapeutics Reports First Quarter 2020 Financial Results and Provides COVID-19 Response Update SOUTH SAN FRANCISCO - May 7, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross t

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DNLI
Apr 2, 2020
DNLIGeneral

DENALI THERAPEUTICS PROVIDES PIPELINE AND BUSINESS UPDATE IN RESPONSE TO THE COVID-19 PANDEMIC SOUTH SAN FRANCISCO

DENALI THERAPEUTICS PROVIDES PIPELINE AND BUSINESS UPDATE IN RESPONSE TO THE COVID-19 PANDEMIC SOUTH SAN FRANCISCO -- April 2, 2020 -- Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the b

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DNLI
Feb 27, 2020
DNLIGeneral

Denali Therapeutics Reports Full Year 2019 Financial Results and Business Highlights

Denali Therapeutics Reports Full Year 2019 Financial Results and Business Highlights SOUTH SAN FRANCISCO - February 27, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-bra

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DNLI
Feb 1, 2020
DNLIGeneral

Denali Therapeutics Announces Closing of Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

SOUTH SAN FRANCISCO, Calif., Jan. 31, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the closing of its upsized underwritten public offering of 9,000,000 shares of its common stock at a price to the public of $23.00 per share, which includes the

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DNLI
Jan 28, 2020
DNLIGeneral

Denali Therapeutics Announces Pricing of Public Offering of Common Stock

Denali Therapeutics Announces Pricing of Public Offering of Common Stock SOUTH SAN FRANCISCO, CA - Jan. 28, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI) today announced the pricing of its underwritten public offering of 7,826,087 shares of its common stock at a price to the pub

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DNLI
Jan 14, 2020
DNLIPhases

DENALI THERAPEUTICS ANNOUNCES BROAD PIPELINE PROGRESS INCLUDING POSITIVE RESULTS FROM ITS LRRK2 PROGRAM FOR PARKINSON'S DISEASE LRRK2 inhibitor DNL201 Phase 1b demonstrated high levels of target and pathway engagement an

DENALI THERAPEUTICS ANNOUNCES BROAD PIPELINE PROGRESS INCLUDING POSITIVE RESULTS FROM ITS LRRK2 PROGRAM FOR PARKINSON'S DISEASE LRRK2 inhibitor DNL201 Phase 1b demonstrated high levels of target and pathway engagement and improvement of lysosomal biomarkers in patients with Park

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DNLI
Nov 6, 2019
DNLIGeneral

Denali Therapeutics Reports Third Quarter 2019 Financial Results and Business Highlights

Denali Therapeutics Reports Third Quarter 2019 Financial Results and Business Highlights SOUTH SAN FRANCISCO - November 6, 2019 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases

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DNLI
Sep 4, 2019
DNLIPhases

Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL151 for Parkinson’s Disease and Launch of Its Engage Parkinson’s Website

Phase 1b study of DNL151 includes Parkinson’s disease patients with and without a genetic LRRK2 mutation Either DNL151 or DNL201 anticipated to be selected for potential registrational clinical trials in 2020 The Engage Parkinson’s website provides patients, caregivers and othe

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DNLI
Aug 6, 2019
DNLIGeneral

Denali Therapeutics Reports Second Quarter 2019 Financial Results and Business Highlights

Denali Therapeutics Reports Second Quarter 2019 Financial Results and Business Highlights SOUTH SAN FRANCISCO - August 6, 2019 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases,

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DNLI
Aug 5, 2019
DNLIPhases

Denali Therapeutics Announces That Its Partner Sanofi has Commenced Dosing of DNL758 in a Phase 1 Study

Sanofi has commenced dosing of DNL758 in a Phase 1 healthy volunteer study. DNL758 is an investigational small molecule RIPK1 inhibitor that does not cross the blood-brain barrier, and is intended for peripheral diseases. Denali will receive a $10 million clinical milestone pay

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DNLI
Jun 11, 2019
DNLIFDA Updates

Denali Therapeutics Receives Orphan Drug and Rare Pediatric Disease Designation for DNL310, and Expands its Portfolio of Brain Penetrant Enzyme Replacement Programs

DNL310 on track to enter Phase 1/2 clinical study in Hunter Syndrome patients in 2020 DNL310 utilizes Denali’s proprietary blood-brain barrier crossing enzyme transport vehicle (“ETV”) technology Two additional ETV-enabled enzyme replacement programs were advanced to pre-clinic

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DNLI
May 8, 2019
DNLIGeneral

Denali Therapeutics Reports First Quarter 2019 Financial Results

Denali Therapeutics Reports First Quarter 2019 Financial Results SOUTH SAN FRANCISCO - May 8, 2019 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today reported financial re

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DNLI
Mar 12, 2019
DNLIGeneral

Denali Therapeutics Reports Full Year 2018 Financial Results and Business Highlights

Denali Therapeutics Reports Full Year 2018 Financial Results and Business Highlights SOUTH SAN FRANCISCO - March 12, 2019 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, toda

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DNLI
Feb 15, 2019
DNLIPhases

Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL747 for Alzheimer’s Disease

SOUTH SAN FRANCISCO, Calif., Feb. 15, 2019 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced initiation of dosing in a Phase 1b clinical s

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DNLI
Jan 8, 2019
DNLIPhases

Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL747 for ALS

SOUTH SAN FRANCISCO, Calif., Jan. 08, 2019 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced initiation of dosing in a Phase 1b clinical s

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DNLI
Dec 10, 2018
DNLIPhases

Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL201 for Parkinson’s Disease

Phase 1b study includes Parkinson’s disease patients with and without a genetic LRRK2 mutation SOUTH SAN FRANCISCO, Calif., Dec. 10, 2018 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates f

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DNLI
Nov 19, 2018
DNLIPhases

DENALI THERAPEUTICS ANNOUNCES POSITIVE CLINICAL RESULTS WITH ITS LEAD RIPK1 INHIBITOR MOLECULE AND INTENTION TO INITIATE PATIENT STUDIES IN MULTIPLE INDICATIONS IN COLLABORATION WITH SANOFI Phase 1 healthy volunteer stud

DENALI THERAPEUTICS ANNOUNCES POSITIVE CLINICAL RESULTS WITH ITS LEAD RIPK1 INHIBITOR MOLECULE AND INTENTION TO INITIATE PATIENT STUDIES IN MULTIPLE INDICATIONS IN COLLABORATION WITH SANOFI SOUTH SAN FRANCISCO-November 19, 2018-Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharm

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DNLI
Nov 8, 2018
DNLIGeneral

Denali Therapeutics Reports Third Quarter 2018 Financial Results and Business Highlights and Announces the Appointment of Jennifer Cook to Board of Directors

Denali Therapeutics Reports Third Quarter 2018 Financial Results and Business Highlights and Announces the Appointment of Jennifer Cook to Board of Directors SOUTH SAN FRANCISCO - November 8, 2018 - Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing

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DNLI
Nov 1, 2018
DNLIGeneral

Denali Therapeutics Announces Broad Collaboration with Sanofi to Develop RIPK1 Inhibitors for the Treatment of Neurological and Inflammatory Diseases Candidate RIPK1 inhibitor molecules have the potential to treat Alzhei

Denali Therapeutics Announces Broad Collaboration with Sanofi to Develop RIPK1 Inhibitors for the Treatment of Neurological and Inflammatory Diseases SOUTH SAN FRANCISCO--November 1, 2018-- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad p

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DNLI
Aug 9, 2018
DNLIGeneral

Denali Therapeutics Reports Second Quarter 2018 Financial Results

Denali Therapeutics Reports Second Quarter 2018 Financial Results SOUTH SAN FRANCISCO - August 9, 2018 - Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today reported financi

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DNLI
Aug 7, 2018
DNLIGeneral

Denali Therapeutics Appoints Dana Andersen, Ph.D., as Chief Technical and Manufacturing Officer

SOUTH SAN FRANCISCO, Calif., Aug. 07, 2018 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today announced that Dr. Dana Andersen has joined the company as

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DNLI
Aug 1, 2018
DNLIPhases

DENALI THERAPEUTICS ANNOUNCES POSITIVE CLINICAL RESULTS FROM LRRK2 INHIBITOR PROGRAM FOR PARKINSON'S DISEASE Healthy volunteer study of DNL201 meets all objectives in phase 1 clinical study, including CSF exposure levels

DENALI THERAPEUTICS ANNOUNCES POSITIVE CLINICAL RESULTS FROM LRRK2 INHIBITOR PROGRAM FOR PARKINSON'S DISEASE SOUTH SAN FRANCISCO - 1 August, 2018 - Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurode

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DNLI
May 30, 2018
DNLIGeneral

Denali Therapeutics Announces Early Exercise of Its Option to Acquire F-star Gamma

Denali Therapeutics Announces Early Exercise of Its Option to Acquire F-star Gamma SOUTH SAN FRANCISCO, May 30, 2018 (GLOBE NEWSWIRE) Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerativ

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DNLI
May 11, 2018
DNLIGeneral

Denali Therapeutics Reports First Quarter 2018 Financial Results

Denali Therapeutics Reports First Quarter 2018 Financial Results SOUTH SAN FRANCISCO, Calif., May 11, 2018 Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today reported

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DNLI
Mar 19, 2018
DNLIPhases

Denali Therapeutics Announces First-In-Human Dosing Of Its RIPK1 Inhibitor Clinical Program And The Appointment Of Peter Klein To Board Of Directors; Reports Fourth Quarter And Full Year 2017 Financial Results And Busine

Denali Therapeutics Announces First-In-Human Dosing Of Its RIPK1 Inhibitor Clinical Program And The Appointment Of Peter Klein To Board Of Directors; Reports Fourth Quarter And Full Year 2017 Financial Results And Business Highlights SOUTH SAN FRANCISCO March 19, 2018 Denali Th

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DNLI
Feb 8, 2018
DNLIGeneral

Denali Therapeutics and Lonza Pharma & Biotech Announce Exclusive Partnership to Develop and Produce Biologic Medicines

Partnership aims to develop drugs for neurodegenerative diseases Denali will draw on Lonza’s expertise in developing and manufacturing complex biologic molecules BASEL, Switzerland and SOUTH SAN FRANCISCO, Calif., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Lonza Pharma & Biotech and Den

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DNLI
Jan 5, 2018
DNLIGeneral

Takeda and Denali Therapeutics Collaborate to Develop and Commercialize Therapies for Neurodegenerative Diseases Collaboration includes three named programs for the treatment of Alzheimer s disease and other neurodegener

Takeda and Denali Therapeutics Collaborate to Develop and Commercialize Therapies for Neurodegenerative Diseases Collaboration includes three named programs for the treatment of Alzheimer s disease and other neurodegenerative diseases, utilizing Denali s Antibody Transport Veh

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DNLI
Dec 20, 2017
DNLIGeneral

Denali Therapeutics Announces Advancement and Expansion of Its LRRK2 Inhibitor Clinical Program for Parkinson’s Disease

SOUTH SAN FRANCISCO, Calif., Dec. 20, 2017 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced that its small molecule inhibitor of leucine-r

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DNLI
Dec 12, 2017
DNLIGeneral

Denali Therapeutics Announces Closing of Initial Public Offering, Including Full Exercise of Underwriters Option to Purchase Additional Shares

Denali Therapeutics Announces Closing of Initial Public Offering, Including Full Exercise of Underwriters Option to Purchase Additional Shares SOUTH SAN FRANCISCO, CA December 12, 2017 Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the closing of its initial public off

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DNLI
Dec 8, 2017
DNLIGeneral

Denali Therapeutics Inc. (Nasdaq: DNLI) to Ring The Nasdaq Stock Market Opening Bell in Celebration of Its IPO

ADVISORY, Dec. 08, 2017 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq:DNLI), a biotechnology company focused on the discovery and development of therapies for patients with neurodegenerative disease, will visit the Nasdaq MarketSite in Times Square in celebration of its i

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DNLI
Dec 8, 2017
DNLIGeneral

Denali Therapeutics Announces Pricing of Initial Public Offering

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2017 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced the pricing of its initial public offering of 13,888,888 shares of its common stock at a price to the public of $18.00 per share. In addition, the underwriters ha

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