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	Saved 2026-07-15 19:59 10d ago Published 2026-07-15 14:06 10d ago	Denali ukončila BIIB122 po neúspěšné studii Denali ukončila BIIB122 poté, co středně pokročilá studie nesplnila primární ani sekundární cíle. Firma ale dál rozvíjí další programy a data z BEACON čeká v 1. pololetí 2027. DNLI Denali Therapeutics	FMP Stock News	78
Original source text Key Takeaways DNLI won FDA approval for Avlayah, the first new Hunter syndrome therapy option in nearly 20 years.DNLI discontinued BIIB122 after a mid-stage trial missed primary and secondary goals.Denali continues advancing multiple pipeline programs, with BEACON data expected in the first half of 2027. Denali Therapeutics, Inc. (DNLI - Free Report) is developing innovative therapies for neurodegenerative diseases using its proprietary TransportVehicle platform, which is designed to help medicines cross the blood-brain barrier. The company is currently developing drugs for neurodegenerative diseases, lysosomal storage disorders and other serious diseases. It received a significant boost earlier this year with the FDA approval of its lead drug, Avlayah, for the treatment of Hunter syndrome. Avlayah is an enzyme replacement therapy indicated for pediatric patients with Hunter syndrome (MPS II), targeting neurological symptoms when initiated early. This accelerated approval is particularly noteworthy as it introduces the first new therapeutic option for this rare disorder in nearly two decades. Denali is also advancing several other pipeline candidates either alone or in collaboration with other partners. The company’s clinical-stage portfolio includes DNL126 for Sanfilippo syndrome type A (MPS IIIA), DNL593 for GRN-related frontotemporal dementia, DNL952 for Pompe disease and DNL628 for Alzheimer's disease. Denali is also advancing several early-stage pipeline candidates, including DNL921 for Alzheimer's disease, DNL111 for Parkinson’s and Gaucher diseases, DNL622 for Hurler syndrome (MPS I), and DNL422 (OTV) for Parkinson’s disease. Denali has also collaborated with other pharma and biotech giants like Sanofi, Biogen (BIIB - Free Report) and Takeda (TAK - Free Report) to develop other candidates. However, recent pipeline setbacks are concerning. In May 2026, Denali and partner Biogen reported disappointing mid-stage results for BIIB122 (DNL151) in early-stage Parkinson's disease, with the study missing both its primary and secondary endpoints. Biogen and Denali subsequently discontinued the development of BIIB122 in idiopathic Parkinson’s disease. Nonetheless, Denali will continue to independently advance the phase IIa BEACON study evaluating the small-molecule inhibitor in patients carrying pathogenic LRRK2 variants. The global BEACON study is designed to assess safety, pharmacokinetics and biomarkers of lysosomal pathway engagement. Data from the BEACON study is expected in the first half of 2027. The study is being led by Denali and funded through a Collaboration and Development Funding Agreement with a third party. Earlier, in April 2026, partner Takeda ended its collaboration on DNL593 for frontotemporal dementia associated with GRN mutations, returning full rights to Denali. While Takeda stated the decision reflected strategic priorities rather than safety or efficacy concerns, the loss of a major pharmaceutical partner reduces external validation and shifts the full development and financial burden to Denali. Competition for DNLI in Parkinson’s DiseasePharma giant Roche (RHHBY - Free Report) is developing prasinezumab, a potential first-in-class antibody for the treatment of Parkinson’s disease that is designed to target a key epitope within the C-terminus of alpha-synuclein, in partnership with Prothena. Roche is conducting the phase III PARAISO study in approximately 900 participants with early-stage Parkinson's disease, with the study's primary completion expected in 2029. Denali’s Price, Valuation and EstimatesShares of the company have surged 37.9% year to date compared with the industry’s growth of 1.1%. Image Source: Zacks Investment Research Going by the price/book ratio, DNLI’s shares currently trade at 3.88X, higher than its mean of 3.02X and the industry’s mean of 3.52X. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2026 loss per share is unchanged at $2.77 over the past 60 days, while that for 2027 loss has narrowed to $2.53 from $2.57 in the same time frame. Image Source: Zacks Investment Research
	Saved 2026-07-09 20:04 16d ago Published 2026-07-09 16:01 16d ago	Denali Therapeutics představí Ryan Watts na AAIC 2026 v Londýně Denali Therapeutics oznámila, že spoluzakladatel a generální ředitel Ryan Watts, Ph.D., vystoupí s úvodním plenárním projevem na Alzheimer’s Association International Conference (AAIC) 2026, která se uskuteční 12.–15. července v Londýně. Firma zároveň představí své kandidáty na léčbu Alzheimerovy choroby DNL628 a DNL921. DNLI Denali Therapeutics	FMP Stock News	78
Original source text July 09, 2026 16:01 ET \| Source: Denali Therapeutics Inc. 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]
	Saved 2026-07-08 20:05 17d ago Published 2026-07-08 15:05 17d ago	Denali rostla po schválení Avlayah a prodeji voucheru Denali Therapeutics letos posílila o 59,4 % díky schválení léčby Avlayah pro Hunterův syndrom, které z ní dělá komerční společnost. Firma navíc očekává 195 milionů USD z prodeje voucheru PRV. DNLI Denali Therapeutics	FMP Stock News	78
Original source text Key Takeaways Denali gained 59.4% YTD as Avlayah approval marked its shift to a commercial-stage company.DNLI will receive $195 million from selling its Rare Pediatric Disease Priority Review Voucher.DNLI regained full rights to DNL593 after Takeda ended the partnership for strategic reasons. Denali Therapeutics, Inc. (DNLI - Free Report) has put up a stupendous year-to-date performance. Shares of the company have surged 59.4% year to date compared with the industry’s growth of 5.9%. The stock has outperformed the sector and the S&P 500 Index during this time frame. The rally is largely attributed to investor optimism surrounding FDA approval of its lead drug, Avlayah, for the treatment of Hunter syndrome, as well as other regulatory updates. DNLI Outperforms Industry, Sector & S&P 500 Index Image Source: Zacks Investment Research While the approval serves as a major catalyst, a deeper assessment of the company's growth drivers and potential risks will be essential to determine whether current levels represent an attractive entry point. Avlayah Approval Positions DNLI for Long-Term UpsideAvlayah is an enzyme replacement therapy indicated for pediatric patients with Hunter syndrome (MPS II), targeting neurological symptoms when initiated early. Developed by Denali, Avlayah is enabled by its TransportVehicle platform, which facilitates delivery of biologics throughout the body, including the brain. Approval was based on strong biomarker data, showing a 91% reduction in cerebrospinal fluid heparan sulfate levels, a key disease marker. This accelerated approval is particularly noteworthy as it introduces the first new therapeutic option for this rare disorder in nearly two decades. The continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory study. Denali’s ongoing global phase II/III COMPASS study is expected to provide confirmatory data and support regulatory filings for tividenofusp alfa-eknm worldwide, including in young adult patients with Hunter syndrome. The approval came with a Rare Pediatric Disease Priority Review Voucher (“PRV”). Last month, DNLI entered into a definitive agreement to sell its PRV, which is expected to generate gross proceeds of $195 million. The added financial flexibility will help advance Denali’s broad TransportVehicle-enabled clinical portfolio for lysosomal storage disorders and neurodegenerative diseases. DNLI’s Other Pipeline CandidatesDenali's clinical-stage portfolio includes DNL126 for Sanfilippo syndrome type A (MPS IIIA), DNL593 for GRN-related frontotemporal dementia, DNL952 for Pompe disease and DNL628 for Alzheimer's disease. Denali is also advancing several early-stage pipeline candidates, including DNL921 for Alzheimer's disease, DNL111 for Parkinson’s and Gaucher diseases, DNL622 for Hurler syndrome (MPS I), and DNL422 (OTV) for Parkinson’s disease. Denali has also collaborated with other pharma and biotech giants like Sanofi (SNY - Free Report) , Biogen (BIIB - Free Report) and Takeda (TAK - Free Report) to develop other candidates. In May 2026, Denali and partner Biogen announced disappointing top-line results from a mid-stage study evaluating BIIB122 (DNL151) in individuals with early-stage Parkinson’s disease. The study did not meet its primary or secondary endpoints. Biogen and Denali have discontinued the development of BIIB122 in idiopathic Parkinson’s disease. Nonetheless, Denali will continue to independently advance the phase IIa BEACON study evaluating the small-molecule inhibitor in patients carrying pathogenic LRRK2 variants. Partner Sanofi is developing eclitasertib for moderate-to-severe ulcerative colitis. In April 2026, Denali announced that partner Takeda decided to terminate their collaboration for DNL593 (PTV:PGRN) in frontotemporal dementia associated with GRN mutations (FTD-GRN). The termination returns full rights to the program to Denali. According to DNLI, Takeda's decision was driven by strategic priorities rather than any efficacy or safety concerns. However, Takeda’s exit may raise concerns. Even though the decision was not tied to safety or efficacy, the loss of a large pharma partner removes external validation and shared financial burden. Denali’s Valuation and EstimatesGoing by the price/book ratio, DNLI’s shares currently trade at 4.51X, higher than its mean of 3.02X for the industry and the industry’s mean of 3.64X. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2026 loss per share has narrowed to $2.77 from $2.90 over the past 60 days, while that for 2027 loss has narrowed to $2.53 from $2.69 in the same time frame. Image Source: Zacks Investment Research Invest in DNLI Stock NowThe approval of Avlayah represents Denali’s transition into a commercial-stage company and a potential inflection point in its long-term growth trajectory. As its first marketed product, Avlayah introduces a new revenue stream, though the pace and scale of commercialization will be critical in determining its ultimate financial impact. Beyond near-term revenues, the approval also validates Denali’s proprietary TransportVehicle platform, which is designed to enable biologic therapies to cross the blood-brain barrier — an area that has historically posed significant challenges. On the financial front, Denali appears well capitalized, ending the first quarter with approximately $1.05 billion in cash and investments. This provides sufficient runway to support ongoing clinical development and strategic initiatives. Narrowing loss estimates indicate improving investor sentiment and a clearer path toward operational leverage. The sale of PRV provides a significant non-dilutive capital infusion, strengthening the company’s balance sheet without requiring an equity raise. We remain bullish on the stock's prospects and believe it offers additional upside potential. Accordingly, we view the shares favorably for prospective investors, while existing shareholders may consider maintaining their positions to capitalize on further growth opportunities.