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Denali Therapeutics: Launch of Avlayah gains momentum and validates blood–brain barrier platform

Denali reports early commercial traction for Avlayah after FDA approval, with roughly $3.6 million in revenue in Q2 2024 and a revenue forecast of $10–12 million for Q3 2024. The approval validates the transferrin receptor platform and strengthens prospects for enzyme replacement therapies, antibodies and oligonucleotides. The Sanfilippo A program DNL593/XAFI shows strong biomarker effects and is targeting a BLA filing in 2027, while Alzheimer’s and FTD programs remain important but carry higher uncertainties. U.S. manufacturing, partnership decisions and potential label expansions for adults remain key operational challenges. » Mais em de.investing.com
Denali: market launch of AVLAYAH gains momentum

Denali reported AVLAYAH sales of $3.6m in the second quarter and forecasts $10–12m for the third quarter, indicating an accelerated commercial rollout. The company has about $1.1bn in cash, which management says should fund plans through 2029. The Phase III COMPASS study is fully recruited; study data are expected at the end of 2027 and are planned for publication by mid-2028. Several other clinical programs could deliver value‑enhancing data in 2027, while manufacturing and regulatory risks continue to determine execution. » Mais em de.investing.com
Denali stock falls after failed phase-2b Parkinson study

Denali shares fell after it was announced that the phase-2b LUMA study of the LRRK2 inhibitor BIIB122 (DNL151), developed with Biogen, failed to meet primary or secondary endpoints. The drug showed peripheral kinase inhibition >90% and reduced a biomarker in cerebrospinal fluid but produced no clinical benefit; BIIB122 will not be pursued for the treatment of idiopathic Parkinson’s. Denali will continue the independent phase-2a BEACON study in carriers of pathogenic LRRK2 variants; data are expected in H1 2027. In premarket trading, Denali stock dropped about 2.9% and Biogen about 1%. » Mais em de.investing.com

Dividendos históricos Dividendos

Todos os indicadores de dividendos Todos os indicadores

Em 2022, Denali Therapeutics já distribuiu € 0,28 em dividendos. A última distribuição ocorreu em abril de 2022.

Dados financeiros da empresa

No último trimestre, Denali Therapeutics registou receitas de € 3,16 mi e um ganho líquido de -€ 111,76 mi

(EUR)	junho de 2026	YoY
Receitas	3,16 mi	-
Ganho bruto	3,08 mi	-
Ganho líquido	-111,76 mi	6,13%
EBITDA	-108,64 mi	6,56%

Dados fundamentais

Métrica	Valor
Capitalização bolsista	€ 2,9 bi
Número de ações	158,71 mi
Máximo/mínimo de 52 semanas	€ 23,65 - € 10,90
Dividendos	Não
Beta	1,00
PER (PE Ratio)	-7,43
PEG (PEG Ratio)	4,34
P/VC (PB Ratio)	4,73
P/V (PS Ratio)	928,74

Perfil da empresa

Denali Therapeutics Inc. ist ein biopharmazeutisches Unternehmen, das in den Vereinigten Staaten therapeutische Kandidaten für neurodegenerative Krankheiten entdeckt und entwickelt. Es bietet Produktkandidaten zur Hemmung der Leucin-reichen Repeat-Kinase 2 (LRRK2) an, darunter BIIB122/DNL151, einen niedermolekularen Hemmstoff, der sich in klinischen Studien der Phasen I und Ib zur Behandlung der Parkinson-Krankheit befindet. Das Unternehmen entwickelt auch DNL310, das sich in klinischen Studien der Phase I/II zur Behandlung des Hunter-Syndroms befindet; DNL343, das sich in einer klinischen Studie der Phase 1 zur Behandlung der amyotrophen Lateralsklerose (ALS) befindet; AR443820/DNL788, das eine klinische Studie der Phase I zur Behandlung von ALS, Multipler Sklerose (MS) und der Alzheimer-Krankheit abgeschlossen hat; und SAR443122/DNL758, das sich in einer klinischen Studie der Phase II zur Behandlung des kutanen Lupus erythematodes befindet. Das Unternehmen hat Kooperationsvereinbarungen mit Takeda Pharmaceutical Company, Genentech, Inc., Sanofi, F-star Gamma Limited, F-star Biotechnologische Forschungs-Und Entwicklungsges M.B.H, F-star Biotechnology Limited, SIRION Biotech GmbH, Genzyme Corporation, Harvard University, der Michael J. Fox Foundation und Centogene sowie eine Forschungs- und Optionsvereinbarung mit Secarna Pharmaceuticals GmbH & Co. KG zur Entwicklung von Antisense-Therapien auf dem Gebiet der neurodegenerativen Erkrankungen. Das Unternehmen war früher als SPR Pharma Inc. bekannt und änderte im März 2015 seinen Namen in Denali Therapeutics Inc. um. Denali Therapeutics Inc. wurde im Jahr 2013 gegründet und hat seinen Hauptsitz in South San Francisco, Kalifornien.

Nome	Denali Therapeutics
CEO	Ryan J. Watts
Sede	South San Francisco, ca EUA
Site	denalitherapeutics.com
Setor	Bens de consumo básico
Indústria	Produtos alimentares
Entrada em bolsa	08/12/2017
Colaboradores	503