Recent 8-K filings for DNLI

• May 21, 2026, 6:17 PM ET other material materiality 0.85 negative item 7.01item 9.01

  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.

• May 7, 2026, 7:59 PM ET earnings materiality 0.80 positive item 2.02item 9.01 ◈ Earnings Releases

  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.

• April 3, 2026, 7:59 PM ET other material materiality 0.70 neutral item 1.02item 9.01 ◈ Material Agreements

  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.

• March 31, 2026, 7:59 PM ET other material materiality 0.80 positive item 2.03item 1.01item 7.01

  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.

• March 25, 2026, 7:59 PM ET regulatory materiality 0.85 positive item 7.01item 9.01

  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.

• February 26, 2026, 6:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01

  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.

• January 6, 2026, 6:59 PM ET other material materiality 0.75 positive item 7.01item 9.01

  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.

• December 10, 2025, 6:59 PM ET other material materiality 0.65 neutral item 1.01item 8.01item 9.01

  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.

• December 4, 2025, 6:59 PM ET other material materiality 0.85 positive item 1.01item 9.01

  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.

• December 4, 2025, 6:59 PM ET other material materiality 0.60 neutral item 7.01item 8.01item 9.01

  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.

• November 6, 2025, 6:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01

  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.

• October 14, 2025, 7:59 PM ET regulatory materiality 0.60 neutral item 7.01item 9.01

  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.

• August 11, 2025, 7:59 PM ET other material materiality 0.85 positive item 2.02item 9.01

  Denali Q2 net loss $124M; FDA priority review for Hunter syndrome BLA, DNL126 accelerated path aligned

  FDA accepted tividenofusp alfa BLA for priority review; PDUFA target action date January 5, 2026.

• July 7, 2025, 7:59 PM ET regulatory materiality 0.85 positive item 7.01item 9.01

  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).

• May 6, 2025, 7:59 PM ET earnings materiality 0.70 neutral item 2.02item 9.01

  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.

• April 2, 2025, 7:59 PM ET regulatory materiality 0.80 positive item 7.01item 9.01

  Denali initiates rolling BLA submission for tividenofusp alfa (Hunter syndrome); launch targeted late 2025/early 2026

  Rolling BLA for accelerated approval of tividenofusp alfa (MPS II) initiated; FDA aligned on CSF HS as surrogate endpoint.

• March 5, 2025, 6:59 PM ET other material materiality 0.85 negative item 7.01

  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.

• February 27, 2025, 6:59 PM ET earnings materiality 0.75 neutral item 1.01item 1.02item 2.02item 9.01

  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.

• January 13, 2025, 6:59 PM ET other material materiality 0.75 positive item 7.01item 9.01

  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.

• January 7, 2025, 6:59 PM ET other material materiality 0.85 negative item 7.01item 9.01

  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.

• November 6, 2024, 6:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01

  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.

• October 10, 2024, 7:59 PM ET other material materiality 0.80 negative item 7.01

  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.

• August 1, 2024, 7:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01

  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.

• May 7, 2024, 7:59 PM ET earnings materiality 0.60 neutral item 2.02item 9.01 ◈ Earnings Releases

  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.

• February 27, 2024, 6:59 PM ET other material materiality 0.75 positive item 1.01item 3.02item 7.01item 9.01 ◈ Material Agreements

  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.

• February 27, 2024, 6:59 PM ET other material materiality 0.80 neutral item 2.02item 9.01 ◈ Earnings Releases

  Denali reports Q4 net loss $119.5M, announces ~$500M PIPE and spin-out of preclinical small molecules

  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).

• February 16, 2024, 6:59 PM ET other material materiality 0.80 negative item 7.01

  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

10 positive 5 negative 16 neutral

source · DNLI on sec.gov