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746,562 Results for "denali therapeutics inc".
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Rare diseases
Denali’s Hunter Syndrome Candidate in the Spotlight After REGENXBIO Rejection
The Hunter syndrome space suffered a setback in February when the FDA turned down REGENXBIO’s investigational gene therapy, raising urgent questions about whether competitor Denali Therapeutics can clear the agency’s bar next month.
March 16, 2026
·
6 min read
·
Ben Hargreaves
Neurodegenerative diseases
Takeda Breaks Up With Denali, Dumps Dementia Drug
Takeda and Denali Therapeutics first partnered in early 2018 to advance drugs for neurodegenerative diseases. One asset, for Alzheimer’s disease, was previously discontinued after an FDA hold and disappointing early data.
April 6, 2026
·
2 min read
·
Tristan Manalac
C-suite
Denali CEO’s ‘greatest professional moment’ arrives as rare disease drug launches
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
April 22, 2026
·
7 min read
·
Annalee Armstrong
Press Releases
Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights
May 8, 2026
·
14 min read
Regulatory
FDA Pauses Denali’s Pompe Plans Due to Preclinical Safety Signals
Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 for Pompe disease.
December 5, 2025
·
2 min read
·
Tristan Manalac
Podcast
Trump’s psychedelics push, Lilly’s up to $7B CAR T deal, Replimune’s saga and Denali’s big win
The deals keep rolling in, with Lilly penning a
$7 billion pact
for gene delivery biotech Kelonia Therapeutics and UCB taking over cell therapy-focused
Neurona Therapeutics
; President Trump signed a new
executive order
supporting the development of psychedelic therapies, sparking fanfare and concern alike; and the FDA’s recent Replimune decision has triggered broader debate about the agency’s flexibility.
April 22, 2026
·
1 min read
·
Heather McKenzie
Press Releases
Orsini Selected as the Exclusive Specialty Pharmacy and Home Infusion Partner for Denali Therapeutics’ AVLAYAH™ (tividenofusp alfa-eknm)
April 20, 2026
·
2 min read
Press Releases
Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)
April 5, 2026
·
7 min read
Press Releases
Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
February 26, 2026
·
13 min read
Press Releases
Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
March 25, 2026
·
17 min read
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