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DNLI

D

Denali Therapeutics Inc. (DNLI)

NMS – Real Time Price. Currency in USD

18.16

-1.57 (-7.98%)

At close: Mar 27, 2026, 4:00 PM EDT

18.28

+0.12 (0.66%)

After-hours: Mar 27, 2026, 6:55 PM EDT

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Denali Wins FDA Nod for Hunter Syndrome Drug, Stock Up

Denali Wins FDA Nod for Hunter Syndrome Drug, Stock Up

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 Inc. (DNLI) Discusses FDA Approval and Commercial Launch Plans for AVLAYAH for Hunter Syndrome Transcript

Denali Therapeutics Inc. (DNLI) Discusses FDA Approval and Commercial Launch Plans for AVLAYAH for Hunter Syndrome Transcript

Denali Jumps, Pulling Regenxbio Higher, On Early FDA Approval

Denali Jumps, Pulling Regenxbio Higher, On Early FDA Approval

Denali Therapeutics won FDA approval Wednesday for the first new drug in 20 years to treat a rare genetic disease.

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.

Denali Therapeutics Inc. (DNLI) Presents at Stifel 2026 Virtual CNS Forum Transcript

Denali Therapeutics Inc. (DNLI) Presents at Stifel 2026 Virtual CNS Forum Transcript

Denali Therapeutics Inc. (DNLI) Presents at Stifel 2026 Virtual CNS Forum Transcript

Denali Gains 11.8% in a Month: Buy, Sell or Hold the Stock?

Denali Gains 11.8% in a Month: Buy, Sell or Hold the Stock?

DNLI stock jumps as investors eye an April 5, 2026, FDA decision on tividenofusp alfa for Hunter syndrome, a key catalyst for growth.

Denali Therapeutics Inc. (DNLI) Presents at TD Cowen 46th Annual Health Care Conference Transcript

Denali Therapeutics Inc. (DNLI) Presents at TD Cowen 46th Annual Health Care Conference Transcript

Denali Therapeutics Inc. (DNLI) Presents at TD Cowen 46th Annual Health Care Conference Transcript

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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.

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

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.

Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™

Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™

SOUTH SAN FRANCISCO, Calif., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced data from programs in Hunter syndrome (mucopolysaccharidosis type II, MPS II), Sanfilippo syndrome type A (MPS IIIA) and Pompe disease that highlight the potential of its Enzyme TransportVehicle™ (ETV) to enable the delivery of enzyme replacement therapies (ERT) to the whole body, including the brain. Data were presented this week at the 22nd Annual WORLDSymposium™ in San Diego, California.

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 Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™

SOUTH SAN FRANCISCO, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the presentation of clinical and preclinical data from its Enzyme TransportVehicle™ (ETV) programs at the upcoming 22nd Annual WORLDSymposium™ to be held February 2-6, 2026, in San Diego, California. These presentations will demonstrate the broad potential of the ETV to enable the delivery of enzyme replacement therapies to the whole body, including the brain.