- Denali co-founder and CEO Ryan Watts, Ph.D., to deliver opening plenary address at 2026 AAIC in London on July 12, 2026
- Presentation will highlight recent scientific advances and future opportunities to accelerate discovery and development of medicines for neurodegenerative diseases
- Denali is advancing multiple investigational therapies designed to cross blood-brain barrier for Alzheimer’s disease, including DNL628 (OTV:MAPT) targeting tau and DNL921 (ATV:Abeta) targeting amyloid beta
SOUTH SAN FRANCISCO, Calif., July 09, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that co-founder and Chief Executive Officer Ryan Watts, Ph.D., will deliver the opening plenary address, titled “Accelerating the Discovery and Development of Medicines for Neurodegeneration,” at the Alzheimer’s Association International Conference® (AAIC), taking place July 12-15 in London. Dr. Watts will discuss recent scientific advances and future opportunities including new insights in the biology of disease, the use of biomarkers for diagnosis and assessment of treatment effect, and the potential for therapeutics to cross the blood-brain barrier for enhanced delivery to the brain.
“We are entering a new era of drug development for Alzheimer’s disease, driven by significant developments in biology, biomarkers and the blood-brain barrier, which has been a major hurdle for the treatment of neurodegenerative disease,” said Dr. Watts. “At Denali, our work has focused on solving the challenge of brain delivery so that people living with neurologic diseases such as Alzheimer’s can benefit from the power of biotherapeutics. We are excited to be part of the community working to transform the lives of millions of individuals and families worldwide by applying these scientific breakthroughs to deliver the next generation of therapies for Alzheimer’s disease.”
Denali Therapeutics has developed and clinically validated the TransportVehicle™, a proprietary technology designed to effectively deliver biologic therapeutics such as antibodies, enzymes and oligonucleotides across the blood-brain barrier by leveraging the body’s natural iron transport system (the transferrin receptor). In March 2026, Denali received accelerated approval from the U.S. Food and Drug Administration for the first and only FDA-approved biologic specifically designed to cross the blood-brain barrier: AVLAYAH™ (tividenofusp alfa-eknm), an enzyme replacement therapy for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.
Denali is developing a broad portfolio of investigational, TransportVehicle-enabled therapeutic candidates including DNL628 (OTV:MAPT) and DNL921 (ATV:Abeta) targeting tau and amyloid beta, respectively, the two hallmark pathologies of Alzheimer’s disease.
DNL628 (OTV:MAPT) is enabled by the Oligonucleotide TransportVehicle™ (OTV) and is designed to target the MAPT gene that encodes for tau, which has been shown to be closely associated with cognitive decline. Preclinical research (link) demonstrated that the OTV achieved broad and uniform central nervous system distribution of antisense oligonucleotides, including deeper brain structures, following intravenous administration as compared to intrathecally delivered therapy.1 The first patients in Denali’s Phase 1b clinical study of DNL628 were dosed in the first half of 2026, and Denali expects clinical safety and biomarker proof-of-concept data from the study in 2027.
DNL921 (ATV:Abeta) is enabled by the Antibody TransportVehicle™ (ATV) and is designed to reduce amyloid plaques. In preclinical research published in the journal Science (link), Denali demonstrated improved brain distribution of ATV:Abeta and reduced risk of swelling and small bleeds in the brain – effects collectively known as amyloid-related imaging abnormalities (ARIA) – compared to conventional antibody treatment. The findings suggest that TransportVehicle-enabled brain delivery of immunotherapy bypasses amyloid-laden large vessels by traveling through smaller capillaries, offering a potential strategy to mitigate ARIA risk seen with first-generation anti-amyloid therapies.2 Denali submitted a Clinical Trial Application (CTA) for DNL921 in the first half of 2026 and, pending regulatory approval of the CTA, expects to initiate a Phase 1/1b clinical trial, with potential for clinical safety and biomarker proof-of-concept data in 2027.
About the Denali TransportVehicle™ Platform
The blood-brain barrier (BBB) is essential in maintaining the brain’s microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for central nervous system diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali’s TransportVehicle™ (TV) platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes and oligonucleotides throughout the whole body, including the brain, by crossing the BBB after intravenous administration. The TV platform is based on engineered Fc domains that bind to specific natural transport receptors, such as transferrin receptor and CD98 heavy chain amino acid transporter, which are expressed at the BBB and deliver the TV and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered with the TV platform demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Oligonucleotides engineered with the TV platform demonstrate more than a 1,000-fold greater brain exposure in primates than systemically delivered oligonucleotides without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates. The TV platform has been clinically validated, with AVLAYAH™ (tividenofusp alfa-eknm) as the first FDA-approved medicine leveraging transferrin receptor to cross the BBB.
About Denali Therapeutics
Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform life for people with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. For more information, please visit www.denalitherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements by Denali’s Chief Executive Officer; statements regarding expectations for Denali’s TransportVehicle™ (TV) platform and its therapeutic and commercial potential; including the potential to deliver enzymes and the Enzyme TransportVehicle™ (ETV) franchise, antibodies and the Antibody TransportVehicle™ (ATV) franchise, and oligonucleotides and the Oligonucleotide TransportVehicle™ (OTV) franchise; statements regarding plans, timelines and expectations related to AVLAYAH™ (tividenofusp alfa-eknm); statements regarding plans, timelines and expectations related to the DNL628 clinical development program, including the ongoing Phase 1 study and timing of data readouts; and statements regarding plans, timelines and expectations related to the DNL921 clinical development program, including the planned Phase 1 study, the potential to mitigate amyloid-related imaging abnormalities (ARIA) and the timing of data readouts. Actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of risks and uncertainties. These include, but are not limited to, uncertainties related to the FDA’s policies and accelerated approval program; risks arising from adverse economic conditions and their impact on Denali’s business and operations; the possibility of events or changes that could lead to the termination of Denali’s collaboration agreements; challenges associated with Denali’s transition to a commercial company; the ability of Denali and its collaborators to complete the development and, if approved, the commercialization of product candidates; difficulties in patient enrollment for ongoing and future clinical trials; whether the current ongoing trials have been powered sufficiently to demonstrate approvability to regulatory agencies; reliance on third-party manufacturers and suppliers for clinical trial materials; dependence on the successful development of Denali’s blood-brain barrier platform technology and related programs; potential delays or failures in meeting expected clinical trial timelines; the risk that promising preclinical profiles may not be replicated in clinical settings; discrepancies between preclinical, early-stage or preliminary clinical results and outcomes from later-stage trials; the occurrence of significant adverse events or other undesirable side effects; the uncertainty surrounding regulatory approvals required for commercialization in the U.S., Europe or other international jurisdictions; Denali’s ability to advance a pipeline of product candidates or develop commercially successful products; developments relating to Denali's competitors and its industry, including competing product candidates and therapies; Denali’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; the implementation and success of Denali’s strategic plans for its business, product candidates and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future financial results in the current environment; and other risks and uncertainties, including those described in Denali's most recent Annual and Quarterly Reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 26, 2026 and May 7, 2026, respectively, and Denali’s future reports to be filed with the SEC. Except for AVLAYAH, Denali's product candidates are investigational, and their safety and efficacy profiles have not yet been established. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali’s expectations, except as required by law.
References
- Barker SJ, Thayer MB, Kim S, et al. Targeting the transferrin receptor to transport anti-sense oligonucleotides across the mammalian blood-brain barrier. Sci Transl Med 2024 Aug 14;16(760).
- Pizzo ME, Plowey ED, Khoury N, et al. Transferrin receptor-targeted anti-amyloid antibody enhances brain delivery and mitigates ARIA. Science 2025 Aug 7;389(6760).
Investor Contact:
Laura Hansen
[email protected]
Media Contact:
Erin Patton
[email protected]