Denali Therapeutics

DNLI

Market cap $3.44B

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.

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.

Denali Therapeutics solved a major challenge in Hunter syndrome treatment. Now it's ready to take its technology further.

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

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