Highest-materiality recent filing
Q2 2026 net loss $127.6M vs $124.1M YoY; R&D $97.0M, SG&A $36.3M.
Denali Therapeutics sells rare pediatric disease PRV for $195M
Gross proceeds of $195M from sale of PRV to a large pharmaceutical company.
Denali sells Rare Pediatric Disease PRV for $195M to fund pipeline
Gross proceeds of $195M from sale of PRV awarded after FDA approval of AVLAYAH for Hunter syndrome in March 2026.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
FDA accepted tividenofusp alfa BLA for priority review; PDUFA target action date January 5, 2026.
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).
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.
Rolling BLA for accelerated approval of tividenofusp alfa (MPS II) initiated; FDA aligned on CSF HS as surrogate endpoint.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
Cash of ~$1.12B as of Sep 30, 2023; expects 2024 OpEx ≤2023, extending runway into 2027.
Denali reports Q3 net loss $99.4M; cuts 2023 expense growth outlook to 15-20%
Net loss $99.4M (vs $103.3M); revenue $1.3M (vs $3.6M). Cash $1.12B.
Denali amends Biogen pacts; milestones unchanged, Biogen waives option rights
Amendment to LRRK2 Collaboration and ROFN agreements executed Aug 17, 2023.
Denali Q2 net income $183M on Biogen opt-in; discontinues DNL919 in Alzheimer's
Net income $183.4M (Q2 2022: net loss $58.8M) on $294.1M collaboration revenue from Biogen's ATV:Abeta option.
Denali reports 64% reduction in NfL with DNL310 in MPS II after 2 years
Mean serum NfL reduction of 64% (p<0.001) from baseline at 2 years in Phase 1/2 study (n=13).
Denali and Biogen revise BIIB122 program; close Phase 3 LIGHTHOUSE, expand Phase 2b LUMA
Denali (DNLI) and Biogen (BIIB) plan to close the Phase 3 LIGHTHOUSE study of BIIB122 in LRRK2-mutation Parkinson's, expected completion 2031; enrolled patients may join LUMA.
Denali Q1 net loss widens to $109.8M; Biogen licenses ATV:Abeta, DNL310 positive data
Net loss $109.8M vs $65.2M YoY; collaboration revenue $35.1M vs $42.1M.
Denali Therapeutics Q4 2022 net loss $98.7M; cash $1.34B; guides 2023 opex up 25-30%
Net loss $98.7M in Q4 2022 vs $75.3M in Q4 2021; full year net loss $326.0M vs $290.6M.
Denali outlines 2023 milestones: four late-stage programs, IND for DNL126, OTV expansion
Four programs expected in late-stage: DNL310 (MPS II), BIIB122 (Parkinson's), SAR443820 (ALS), DNL343 ALS Phase 2/3
Denali Q3 net loss widens to $103.3M; cash at $1.11B after $296M offering
Net loss of $103.3M for Q3 2022 vs. $84.6M in Q3 2021; collaboration revenue fell to $3.6M from $5.3M.
Denali Therapeutics prices $275M public offering of 10.4M shares at $26.50/share
Priced 10,377,359 shares of common stock at $26.50 per share for gross proceeds of ~$275M.
Denali Therapeutics announces $250M public offering of common stock
Denali to sell $250M of common stock; underwriters have 30-day option for additional 15%.
Denali reports Q2 net loss $58.8M; collaboration revenue $52.5M on $40M Sanofi milestone
Net loss $58.8M vs $60.7M year ago; cash and securities $1.16B as of June 30, 2022.
Denali receives CTA clearance for DNL919 Phase 1 study; FDA clinical hold remains unresolved
Denali receives CTA clearance to initiate Phase 1 study of DNL919 (ATV:TREM2) in healthy volunteers in the Netherlands.
Alexander Schuth, M.D., current Chief Operating Officer and Secretary of the Company, will add the Chief Financial Officer role to his current responsibilities, becoming Denali’s Chief Operating and Financial Officer.
Steve Krognes will transition from his role as Chief Financial Officer to join the Company’s Board of Directors as of May 1, 2022
On March 14, 2022, Mr. Krognes was appointed to the Board, effective May 1, 2022.
On February 3, 2022, Erik Harris was appointed to the Board of Directors (the “Board”) and to the Audit Committee of the Board (the "Audit Committee") of Denali Therapeutics Inc. (the “Company”).
Max materiality 0.85 · Median 0.75 · Most common event other_material