Recent 8-K filings for DNLI
Highest-materiality recent filing
Denali & Biogen halt BIIB122 in idiopathic Parkinson's after Phase 2b miss; BEACON continues
- Phase 2b LUMA study of BIIB122 (DNL151) in 648 early-stage Parkinson's patients failed primary and secondary endpoints.
- BIIB122 did not slow disease progression vs placebo on MDS-UPDRS Part II+III combined score.
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Denali annual meeting results: all director nominees elected, auditor ratified, say-on-pay approved
Elected three Class III directors: Jennifer Cook, David Schenkein, Ryan Watts; broker non-votes ~13.1M.
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Denali & Biogen halt BIIB122 in idiopathic Parkinson's after Phase 2b miss; BEACON continues
Phase 2b LUMA study of BIIB122 (DNL151) in 648 early-stage Parkinson's patients failed primary and secondary endpoints.
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Denali reports Q1 2026 net loss $128.4M; AVLAYAH approved and launched for Hunter syndrome
Net loss of $128.4M for Q1 2026 vs $133.0M in Q1 2025; R&D expenses down $12.4M to $103.8M.
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Denali regains full rights to DNL593 after Takeda terminates collaboration
Takeda terminated co-development agreement for DNL593 (PTV:PGRN) effective 60 days from April 3, 2026; reason is strategic, not safety/efficacy.
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Denali Therapeutics receives $200M from Royalty Pharma after FDA approval of tividenofusp alfa
Received $200.0M gross proceeds from Royalty Pharma under synthetic royalty funding agreement.
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Denali Therapeutics receives FDA approval for AVLAYAH in Hunter syndrome
FDA grants accelerated approval for AVLAYAH (tividenofusp alfa) to treat neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients ≥5 kg.
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Denali Q4 2025 net loss $128.5M; tividenofusp alfa PDUFA date April 5, 2026
Q4 2025 net loss $128.5M vs $114.8M in Q4 2024; full year net loss $512.5M vs $422.8M in 2024.
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Denali outlines 2026 milestones: PDUFA April 5 for Hunter syndrome, multiple pipeline readouts
Preparing for commercial launch of tividenofusp alfa (Hunter syndrome) with PDUFA target action date April 5, 2026; results published in NEJM.
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Denali prices $200M public offering of common stock and pre-funded warrants
Prices 9.14M shares at $17.50 and 2.29M pre-funded warrants at $17.49, raising ~$200M gross proceeds.
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Denali secures $275M royalty funding from Royalty Pharma on tividenofusp alfa
Royalty Pharma pays $200M at close conditional on FDA accelerated approval by June 30, 2026.
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Denali pipeline update: DNL952 on clinical hold; PDUFA date Apr 2026 for Hunter syndrome
BLA for tividenofusp alfa (Hunter syndrome) under FDA review; PDUFA target action date April 5, 2026. Enrollment in Cohort A expected to complete Dec 2025.
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Denali Q3 net loss $126.9M; tividenofusp alfa PDUFA extended to April 2026
Net loss $126.9M vs $107.2M in Q3 2024; cash $872.9M at Sept 30, 2025.
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FDA extends Denali's PDUFA date for tividenofusp alfa to April 5, 2026
FDA extended PDUFA target date from Jan 5 to April 5, 2026 for tividenofusp alfa BLA for Hunter syndrome.
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FDA accepted tividenofusp alfa BLA for priority review; PDUFA target action date January 5, 2026.
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FDA accepts Denali's BLA for tividenofusp alfa with Priority Review; PDUFA Jan 5, 2026
FDA grants Priority Review for BLA seeking accelerated approval of tividenofusp alfa for Hunter syndrome (MPS II).
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Julian C. Baker elected as Class II director; 98.0M votes for, 22.9M withheld.
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Denali completes BLA submission for Hunter syndrome; Q1 net loss widens to $133M
Net loss of $133.0M in Q1 2025 vs $101.8M in Q1 2024; R&D expense rose to $116.2M.
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Rolling BLA for accelerated approval of tividenofusp alfa (MPS II) initiated; FDA aligned on CSF HS as surrogate endpoint.
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Further analyses of DNL343 in ALS show no NfL treatment effect; extension discontinued
Further analyses of Regimen G DNL343 showed no treatment effect on neurofilament light (NfL) biomarker over 24-week double-blind period.
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Denali reports FY2024 net loss $422.8M; BLA for MPS II drug planned early 2025
Net loss $114.8M Q4 and $422.8M FY2024, vs $119.5M and $145.2M in prior year.
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Denali tividenofusp alfa gets FDA Breakthrough Therapy; BLA submission in early 2025
FDA granted Breakthrough Therapy Designation for tividenofusp alfa in Hunter syndrome (MPS II) on Jan 7, 2025.
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Denali's DNL343 fails Phase 2/3 ALS trial; primary endpoint not met
Primary endpoint of ALSFRS-R and survival at 24 weeks not met vs placebo.
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Denali Therapeutics amends bylaws for universal proxy and Delaware law updates
Board approved amended restated bylaws effective November 12, 2024.
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Denali Q3 net loss $107.2M; tividenofusp BLA planned early 2025; DNL126 shows biomarker reduction
Net loss $107.2M vs $99.4M YoY; no collaboration revenue; cash $1.28B at Sep 30, 2024.
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Denali partner Sanofi discontinues K2 Phase 2 study of oditrasertib in MS after missing endpoints
Sanofi discontinued K2 Phase 2 study of oditrasertib (SAR443820/DNL788) in multiple sclerosis.
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Denali Q2 net loss $99M; FDA open to accelerated approval for DNL310; regains ATV:Abeta rights
Net loss $99.0M in Q2 2024 vs $183.4M net income in Q2 2023; no collaboration revenue versus $294.1M last year.
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Denali shareholders elect directors, ratify auditor, approve executive compensation
Three Class I directors elected: Jay Flatley (108.1M for), Mac Tessier-Lavigne (82.2M for), Nancy Thornberry (108.3M for).
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Denali Q1 net loss $101.8M, cash $1.43B; reports pipeline progress and $500M PIPE
Net loss $101.8M vs $109.8M YoY; zero collaboration revenue vs $35.1M in Q1 2023.
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Denali raises $500M via PIPE at $17.07/share, adds pre-funded warrants
Gross proceeds of ~$500M from 3.2M shares at $17.07 and 26M pre-funded warrants at $17.06.
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Net loss $119.5M in Q4 vs $98.7M YoY; full year net loss $145.2M vs $326.0M on $330.5M collaboration revenue (Biogen ATV:Abeta option $293.9M).
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Denali partner Sanofi reports Phase 2 ALS trial miss for RIPK1 inhibitor DNL788
Phase 2 HIMALAYA study of SAR443820/DNL788 in ALS did not meet primary endpoint (ALSFRS-R).
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.85 · Median 0.75 · Most common event other_material