Denali Therapeutics Inc.

132 articles about Denali Therapeutics Inc.

• Denali Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights

  5/3/2021

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today reported financial results for the first quarter ended March 31, 2021, and provided business highlights.

• Denali Therapeutics Presents Positive Results from Phase 1 and Phase 1b Studies of Its LRRK2 Inhibitor, BIIB122/DNL151, Supporting Late-Stage Development Plans in Parkinson’s Disease

  5/1/2021

  Treatment with BIIB122/DNL151 achieved robust reductions in biomarkers of target engagement and pathway engagement in healthy volunteers and patients with Parkinson’s disease

• Denali Therapeutics Announces Fast Track Designation Granted by the U.S. FDA to ETV:IDS (DNL310) for the Treatment of Patients with Hunter Syndrome (MPS II)

  3/11/2021

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome (MPS II). 

• Denali Therapeutics Reports Full Year 2020 Financial Results and Business Highlights

  2/25/2021

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today reported financial results for the full year ended December 31, 2020 and provided business highlights.

• Denali Therapeutics Reports Positive Three-Month Data from Phase 1/2 Study with ETV:IDS (DNL310) in Patients with Hunter Syndrome (MPS II)

  2/12/2021

  Denali Therapeutics today announced additional positive interim results from the ongoing Phase 1/2 study evaluating ETV:IDS (DNL310) as a potential brain-penetrant enzyme replacement therapy for treating both central nervous system

• Denali Therapeutics to Present New Data on ETV:IDS (DNL310) for the Potential Treatment of Hunter Syndrome at WORLDSymposium™– Management to host webinar for analysts on Friday, Feb. 12, at 8:00 a.m. Eastern Time –

  2/5/2021

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced its participation at the 17th Annual WORLDSymposium™

• Denali Therapeutics Announces Appointment of Nancy Thornberry to Board of Directors

  1/11/2021

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that Nancy Thornberry has joined the Board of Directors, effective January 8, 2021. Ms. Thornberry’s extensive biotech leadership and pharmaceutical experience includes more than 30 years of development and discovery

• Denali Therapeutics Announces Significant Program Progress and Expected Key Milestones in 2021 for Its Broad Therapeutic Portfolio in Neurodegeneration

  1/8/2021

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced program progress and expected milestones for 2021, which Chief Executive Officer, Ryan Watts, Ph.D.,

• Denali Therapeutics Announces First Human Biomarker Proof of Concept for Its Transport Vehicle (TV) Technology Achieved in Phase 1/2 Study of ETV:IDS (DNL310) in Hunter Syndrome (MPS II)

  11/10/2020

  After four weekly intravenous doses of DNL310, a 76% mean reduction in CSF GAG levels (heparan sulfate) from baseline was observed, with normal healthy levels being achieved in four of five patients Based on Cohort A safety data review, an independent data monitoring committee recommended continuing the study without modifications, enabling progression to Cohort B,

• Denali Therapeutics Reports Third Quarter 2020 Financial Results and Business Highlights

  11/5/2020

  Denali Therapeutics Inc., a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for neurodegenerative diseases, reported financial results for the third quarter ended September 30, 2020 and provided business highlights.

• Denali Therapeutics to Highlight Progress Across Broad Biotherapeutics Portfolio for Neurodegeneration Enabled by Its Blood-Brain Barrier (BBB) TV Platform at Virtual R&D Day Today

  10/15/2020

  Proprietary and differentiated Transport Vehicle (TV) technology shows potential to solve the BBB challenge by delivering biotherapeutics to the brain New preclinical data support the potential for systemic administration of ETV:IDS (DNL310) to treat the neurological pathology of Hunter syndrome and replace standard-of-care therapy Early safety and biomarker data from ongoing Phase 1/2 trial of DNL310 expected by year end 2020 and, if positive, these data would validate Denali’s TV technology

• Secarna Pharmaceuticals and Denali Therapeutics Enter Into Research and Option Agreement to Develop Novel Antisense Therapies in the Field of Neurodegenerative Diseases

  10/13/2020

  Secarna Pharmaceuticals GmbH today announced that the Company has signed a Research and Option Agreement with Denali Therapeutics Inc.

• Denali Therapeutics Announces Closing of Collaboration and Share Purchase Agreements with Biogen

  10/7/2020

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced the signing of a Definitive LRRK2 Collaboration and License Agreement and a Right of First Negotiation, Option and License Agreement with Biogen,

• Denali Therapeutics to Host Webinar on Transporting Biotherapeutics Across the Blood-Brain Barrier

  9/30/2020

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for treatment of neurodegenerative diseases, today announced that it will host a webinar on transporting biotherapeutics across the BBB on Thursday, October 15th from 1:00 p.m. to 4:00 p.m. Eastern Time.

• Denali Therapeutics Reports Second Quarter 2020 Financial Results and Business Highlights

  8/7/2020

  Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (“BBB”) for neurodegenerative diseases, today reported financial results for the second quarter ended June 30, 2020 and provided business highlights. “We are thrilled with the strong progress across our pipeline, the continued productivity across the company despite th

• Denali Therapeutics Announces Decision to Advance DNL151 into Late Stage Clinical Studies in Parkinson’s Patients

  8/6/2020

  Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that DNL151 has been selected to progress into late stage studies in Parkinson’s disease patients with a kinase activating mutation in LRRK2 and in sporadic Parkinson’s disease patients

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  Denali and Biogen Ink Parkinson’s Pact Worth $2.125 Billion

  8/6/2020

  Biogen and Denali Therapeutics inked a binding deal to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease.

• Biogen and Denali to Collaborate on LRRK2 Program for Parkinson’s Disease and Certain TV Platform-Enabled Programs for Neurodegenerative Diseases

  8/6/2020

  Biogen to receive license to co-develop and co-commercialize Denali’s small molecule LRRK2 inhibitor program, expanding pipeline of potential therapies in Parkinson’s disease and other movement disorders Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s blood-brain barrier crossing TV technology platform, including for amyloid beta, plus right of first negotiation for two additional unnamed TV platform programs Denali to receive

• Denali Therapeutics Announces Phase 1b Study by Partner Sanofi of RIPK1-Inhibitor DNL758 (SAR443122) in COVID-19 Patients

  7/29/2020

  Dosing of DNL758 (SAR443122) has commenced in a randomized, double-blind, placebo-controlled Phase 1b trial to evaluate safety and effect on the immune system in severe COVID-19 DNL758, discovered by Denali and partnered with Sanofi, is a small molecule inhibitor of RIPK1 that does not cross the blood-brain barrier, and is being developed for patients with peripheral inflammatory diseases

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  Clinical Catch-Up: June 8-12

  6/15/2020

  It was a fairly busy week with clinical trial updates and announcements. Here’s a look.