Denali Stock Dips as Biogen-Partnered Parkinson's Disease Study Fails
DNLI sinks after BIIB122 failed a mid-stage Parkinson's study, prompting Denali and Biogen to halt development in idiopathic cases.
DNLI - Denali Therapeutics Inc.
DNLI sinks after BIIB122 failed a mid-stage Parkinson's study, prompting Denali and Biogen to halt development in idiopathic cases.
This biotech develops therapies for neurodegenerative diseases, advancing a broad pipeline through strategic pharmaceutical partnerships.
Denali Therapeutics NASDAQ: DNLI is seeing early commercial interest for its first approved drug, AVLAYAH, following its March 24 accelerated approval for Hunter syndrome, Chief Operating Officer and Chief Financial Officer Alexander Schuth said at a Bank of America Securities conference.
Denali Therapeutics Inc. (DNLI) Presents at Bank of America Global Healthcare Conference 2026 Transcript
Denali narrows its Q1 loss and gains FDA approval for Avlayah, the first new Hunter syndrome treatment option in nearly 20 years.
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).
This biotech company develops therapies for neurodegenerative and rare diseases, supported by clinical assets and pharma collaborations.
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.
DNLI secures FDA nod for Avlayah, a first-in-decades Hunter syndrome therapy, but pipeline risks and Takedas exit complicate the outlook.
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.
Takeda on Friday notified Denali Therapeutics regarding the termination of their collaboration agreement to co-develop DNL593, a progranulin replacement therapy for frontotemporal dementia.
Capricorn Fund Managers Ltd acquired a new stake in Denali Therapeutics Inc. (NASDAQ: DNLI) in the fourth quarter, according to the company in its most recent filing with the Securities and Exchange Commission. The institutional investor acquired 62,197 shares of the company's stock, valued at approximately $1,027,000. Other institutional investors and hedge funds
SG Americas Securities LLC boosted its holdings in Denali Therapeutics Inc. (NASDAQ: DNLI) by 291.6% in the fourth quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The institutional investor owned 149,592 shares of the company's stock after buying an additional 111,391 shares during the period. SG Americas
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
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.
DNLI surges after FDA approves Avlayah, its first commercial drug and a breakthrough Hunter syndrome therapy targeting the brain.
Denali Therapeutics Inc. (DNLI) Discusses FDA Approval and Commercial Launch Plans for AVLAYAH for Hunter Syndrome Transcript
Denali Therapeutics won FDA approval Wednesday for the first new drug in 20 years to treat a rare genetic disease.
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.
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