Denali Therapeutics Inc. (DNLI)

NMS – Real Time Price. Currency in USD

19.46

-0.21 (-1.07%)

At close: May 12, 2026, 4:00 PM EDT

19.30

-0.16 (-0.82%)

After-hours: May 12, 2026, 7:14 PM EDT

08.05.2026

DNLI Q1 Loss Narrower Than Expected, Avlayah Approval Boosts Prospects

Denali narrows its Q1 loss and gains FDA approval for Avlayah, the first new Hunter syndrome treatment option in nearly 20 years.

07.05.2026

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

SOUTH SAN FRANCISCO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2026, and provided business highlights, including the recent U.S. Food and Drug Administration (FDA) approval of AVLAYAH™ (tividenofusp alfa-eknm).

03.05.2026

Denali: The First Commercial Validation Of The Blood-Brain Barrier Platform

Denali Therapeutics has transitioned from a speculative platform to a commercial-stage rare disease company with FDA approval of AVLAYAH for Hunter syndrome. DNLI's TransportVehicle technology enables delivery of biologics across the blood-brain barrier, providing significant differentiation and commercial potential in neurodegenerative and lysosomal storage diseases. With $1.17 billion in pro-forma liquidity and a focused initial launch, DNLI is positioned for 2.8 years of runway, reducing near-term capital risk.

17.04.2026

DNLI Gains 25.4% Year to Date: Should You Buy, Sell or Hold the Stock?

DNLI secures FDA nod for Avlayah, a first-in-decades Hunter syndrome therapy, but pipeline risks and Takedas exit complicate the outlook.

07.04.2026

Denali Stock Falls as Partner Takeda Ends Collaboration Deal

DNLI's shares decline after Takeda exits DNL593 partnership, leaving Denali to fully control and fund the therapy as it advances studies and plans 2026 data release.

06.04.2026

Takeda Exits Dementia Drug Partnership With Denali Therapeutics - Here's Why

Takeda on Friday notified Denali Therapeutics regarding the termination of their collaboration agreement to co-develop DNL593, a progranulin replacement therapy for frontotemporal dementia.

03.04.2026

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

SOUTH SAN FRANCISCO, Calif., April 03, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that it has received notification from Takeda of its decision to terminate the collaboration agreement between the two companies to co-develop and co-commercialize DNL593 (PTV:PGRN). The decision was driven by strategic considerations and is not related to efficacy or safety data. DNL593 is an investigational progranulin replacement therapy utilizing Denali's Protein TransportVehicle™ (PTV) to deliver progranulin across the blood-brain barrier to the brain for the treatment of frontotemporal dementia-granulin (FTD-GRN). Denali has led development activities and will regain full control of DNL593 and its intellectual property portfolio.

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07.05.2026

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

03.04.2026

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

25.03.2026

Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)

SOUTH SAN FRANCISCO, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for AVLAYAH™ (tividenofusp alfa-eknm), the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. AVLAYAH is an enzyme replacement therapy indicated for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

26.02.2026

Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

SOUTH SAN FRANCISCO, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business highlights.

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Denali Therapeutics Inc. (DNLI)

DNLI Q1 Loss Narrower Than Expected, Avlayah Approval Boosts Prospects

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

Denali: The First Commercial Validation Of The Blood-Brain Barrier Platform

DNLI Gains 25.4% Year to Date: Should You Buy, Sell or Hold the Stock?

Denali Stock Falls as Partner Takeda Ends Collaboration Deal

Takeda Exits Dementia Drug Partnership With Denali Therapeutics - Here's Why

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Videos

No Data

Press releases

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)

Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

DNLI Q1 Loss Narrower Than Expected, Avlayah Approval Boosts Prospects

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

Denali: The First Commercial Validation Of The Blood-Brain Barrier Platform

DNLI Gains 25.4% Year to Date: Should You Buy, Sell or Hold the Stock?

Denali Stock Falls as Partner Takeda Ends Collaboration Deal

Takeda Exits Dementia Drug Partnership With Denali Therapeutics - Here's Why

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Videos

No Data

Press releases

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)

Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

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Denali Therapeutics Inc. (DNLI)

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Denali Therapeutics Inc. (DNLI)

DNLI Q1 Loss Narrower Than Expected, Avlayah Approval Boosts Prospects

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

Denali: The First Commercial Validation Of The Blood-Brain Barrier Platform

DNLI Gains 25.4% Year to Date: Should You Buy, Sell or Hold the Stock?

Denali Stock Falls as Partner Takeda Ends Collaboration Deal

Takeda Exits Dementia Drug Partnership With Denali Therapeutics - Here's Why

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Videos

No Data

Press releases

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)

Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

DNLI Q1 Loss Narrower Than Expected, Avlayah Approval Boosts Prospects

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

Denali: The First Commercial Validation Of The Blood-Brain Barrier Platform

DNLI Gains 25.4% Year to Date: Should You Buy, Sell or Hold the Stock?

Denali Stock Falls as Partner Takeda Ends Collaboration Deal

Takeda Exits Dementia Drug Partnership With Denali Therapeutics - Here's Why

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Videos

No Data

Press releases

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)

Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights