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582,030 Results for "denali therapeutics inc".
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Earnings
Denali climbs past Avlayah expectations with $3.6M in revenue
After launching in April, Hunter syndrome drug Avlayah surprised analysts with a strong first quarter, as patients rush to get access to Denali Therapeutics’ new option.
August 10, 2026
·
2 min read
·
Annalee Armstrong
Drug Development
Biogen’s Alzheimer’s results bolster tau theory—and Denali’s next gen candidate
If Biogen has shown that tau can impact cognition, Denali’s technology—validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact, analysts said.
May 15, 2026
·
3 min read
·
Annalee Armstrong
FDA
Denali sells FDA voucher for $195M to support neurodegenerative pipeline
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
June 19, 2026
·
1 min read
·
Annalee Armstrong
Press Releases
Denali Therapeutics Reports Second Quarter 2026 Financial Results and Business Highlights
August 7, 2026
·
17 min read
Parkinson’s disease
Biogen, Denali pull plug on Parkinson’s program after mid-stage flop
Biogen and Denali’s Parkinson’s disease drug failed to significantly slow disease progression in a Phase 2b study, missing both primary and secondary endpoints.
May 22, 2026
·
2 min read
·
Tristan Manalac
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
Press Releases
Denali Therapeutics to Report Second Quarter 2026 Financial Results and Business Highlights on August 6, 2026
July 27, 2026
·
1 min read
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
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
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