Denali Therapeutics Inc. logo DNLI - Denali Therapeutics Inc.

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| PRICE TARGET: $30.80 DETAILS
HIGH: $40.00
LOW: $23.00
MEDIAN: $31.00
CONSENSUS: $30.80
UPSIDE: 65.24%

Stock News

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

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.

May 02, 2026 08:13 PM seekingalpha.com
Denali Therapeutics Inc. (NASDAQ:DNLI) Receives Average Rating of “Moderate Buy” from Analysts

Denali Therapeutics Inc. (NASDAQ:DNLI) Receives Average Rating of “Moderate Buy” from Analysts

Denali Therapeutics Inc. (NASDAQ: DNLI - Get Free Report) has been given a consensus recommendation of "Moderate Buy" by the sixteen ratings firms that are covering the stock, MarketBeat.com reports. One equities research analyst has rated the stock with a sell recommendation, one has given a hold recommendation, twelve have issued a buy recommendation and two

Apr 04, 2026 10:35 PM defenseworld.net
Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

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.

Apr 03, 2026 09:30 AM globenewswire.com
Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)

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.

Mar 25, 2026 07:50 AM globenewswire.com
Denali Therapeutics CEO: 2026 Pivotal With Hunter Syndrome FDA Decision and New TV Trial Readouts

Denali Therapeutics CEO: 2026 Pivotal With Hunter Syndrome FDA Decision and New TV Trial Readouts

Denali Therapeutics (NASDAQ: DNLI) founder and CEO Ryan Watts said 2026 is shaping up to be a pivotal year for the company as it approaches a potential first product approval and advances multiple transport vehicle-enabled programs across rare disease and neurodegeneration. Speaking in a moderated discussion, Watts highlighted the company's pending FDA decision for tividenofusp alfa

Mar 20, 2026 09:02 PM defenseworld.net

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