Denali Therapeutics Inc. (DNLI) has taken back full rights to its investigational therapy DNL593 (PTV: PGRN), a progranulin replacement candidate for, GRN-related Frontotemporal Dementia (FTD-GRN), following Takeda's decision to end the companies' co-development agreement for strategic-not safety or efficacy-reasons.
A Reset That Strengthens Denali's Hand
Frontotemporal Dementia (FTD) is one of the most common forms of dementia in people under 60, often leading to rapid decline in personality, behaviors, language, and motor function. For individuals with GRN mutations, progranulin levels drop sharply, and there are currently no approved treatments that slow or halt disease progression.
DNL593 is designed to address this gap by delivering progranulin directly to the brain using Denali's TransportVehicle (TV) platform, which CEO Ryan Watts, Ph.D., has described as "the first FDA-approved blood-brain barrier-crossing technology."
Clinical Progress Remains on Track
Denali emphasized that the program remains on track, with Phase 1/2 results in FTD-GRN patients expected by the end of 2026. Enrollment is complete at 40 participants.Interim data from healthy volunteers in Part A of the study previously showed a dose-dependent increase in cerebrospinal fluid progranulin, confirming robust brain delivery and favorable tolerability, with no significant safety signals reported to date.
CEO Ryan Watts, Ph.D., noted that regaining full ownership allows Denali to "advance DNL593 independently" while continuing to build on the scientific rationale and early data supporting the program.
Why the TransportVeicle Platform Matters
The blood-brain barrier has historically blocked most large-molecule drug from reaching the brain. Denali's TV platform uses engineered Fc domains that bind to the natural transport receptors- such as transferrin receptor and CD98 heavy chain-to shuttle therapeutic cargo into the brain via receptor-mediated transcytosis.
In preclinical models, TV-enabled molecules have shown:
•10-30x higher brain exposure for antibodies and enzymes
•Over 1,000x higher exposure for oligonucleotides in primates compared with non-TV versions
Five TV-enabled programs are now in clinical development, underscoring the platform's broad potential across neurodegenerative and lysosomal storage disorders.
What Comes NextWith Takeda Stepping aside, Denali now holds full control of DNL593's intellectual property and development path. The company's next major milestone will be the Phase 1/2 patient data readout at the end of 2026, including biomarker results that could validate strategy in FTD-GRN.
DNLI has traded between $10.57 and $23.77 over the past year. The company closed Thursday's (April 2, 2026) trading at $20.65, up 4.93%. During the overnight session the stock is down by $20.05, down 2.91%.
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