{"filings":[{"id":842441,"accession_number":"0001714899-26-000074","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2026-06-03T22:43:26+00:00","items":["5.07","9.01"],"status":"ready","headline":"Denali annual meeting results: all director nominees elected, auditor ratified, say-on-pay approved","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Elected three Class III directors: Jennifer Cook, David Schenkein, Ryan Watts; broker non-votes ~13.1M.","Ratified Ernst & Young as auditor for FY2026: 137.5M for, 420K against, 49.6K abstain.","Non-binding advisory vote on executive compensation approved: 117.0M for, 7.1M against, 717.7K abstain.","Quorum of 86.96% of outstanding shares (137.99M of 158.68M) represented at meeting."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":590687,"accession_number":"0001714899-26-000070","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2026-05-21T22:17:45+00:00","items":["7.01","9.01"],"status":"ready","headline":"Denali & Biogen halt BIIB122 in idiopathic Parkinson's after Phase 2b miss; BEACON continues","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["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.","Biogen and Denali discontinue further development of BIIB122 in idiopathic Parkinson's disease.","Denali continues independent Phase 2a BEACON study in LRRK2 pathogenic variant carriers; data expected H1 2027.","Biomarker data showed >90% peripheral LRRK2 kinase inhibition and ~30% CSF pRab10 reduction."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":94934,"accession_number":"0001714899-26-000062","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2026-05-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali reports Q1 2026 net loss $128.4M; AVLAYAH approved and launched for Hunter syndrome","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $128.4M for Q1 2026 vs $133.0M in Q1 2025; R&D expenses down $12.4M to $103.8M.","FDA granted accelerated approval for AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome on March 25, 2026; first commercial patients dosed in April.","Cash and marketable securities at $1.05B as of March 31, 2026; $200M gross proceeds received from Royalty Pharma synthetic royalty agreement.","Takeda terminated DNL593 (FTD-GRN) collaboration; Denali retains full rights, Phase 1/2 data expected by end of 2026.","First patient dosed in Phase 1b study of DNL628 (OTV:MAPT) for Alzheimer's disease; data expected in 1H 2027."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.69,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2026-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":94933,"accession_number":"0001714899-26-000042","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2026-04-03T23:59:59+00:00","items":["1.02","9.01"],"status":"ready","headline":"Denali regains full rights to DNL593 after Takeda terminates collaboration","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Takeda terminated co-development agreement for DNL593 (PTV:PGRN) effective 60 days from April 3, 2026; reason is strategic, not safety/efficacy.","Denali will continue Phase 1/2 study independently; results expected by end of 2026.","Enrollment complete with 40 FTD-GRN participants; interim data showed dose-dependent CSF progranulin increases and favorable tolerability.","Denali has no further financial obligations to Takeda post-termination and retains full intellectual property rights.","DNL593 uses TransportVehicle platform, first FDA-approved BBB-crossing technology, addressing FTD-GRN with no approved slowing treatments."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":107669,"accession_number":"0001714899-26-000036","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2026-03-31T23:59:59+00:00","items":["2.03","1.01","7.01"],"status":"ready","headline":"Denali Therapeutics receives $200M from Royalty Pharma after FDA approval of tividenofusp alfa","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Received $200.0M gross proceeds from Royalty Pharma under synthetic royalty funding agreement.","Closing followed FDA accelerated approval of tividenofusp alfa on March 24, 2026.","Synthetic royalty agreement was previously announced on December 4, 2025.","Proceeds provide non-dilutive capital for further development and commercialization."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":107668,"accession_number":"0001714899-26-000030","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2026-03-25T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Denali Therapeutics receives FDA approval for AVLAYAH in Hunter syndrome","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA grants accelerated approval for AVLAYAH (tividenofusp alfa) to treat neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients ≥5 kg.","First FDA-approved biologic designed to cross the blood-brain barrier using TransportVehicle platform.","Approval based on 91% reduction in CSF heparan sulfate biomarker at week 24; 93% of patients reached normal range.","Most common adverse reaction: infusion-related reactions; continued approval contingent on confirmatory COMPASS trial.","FDA awarded Rare Pediatric Disease Priority Review Voucher (PRV) in connection with approval."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":107667,"accession_number":"0001714899-26-000020","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2026-02-26T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali Q4 2025 net loss $128.5M; tividenofusp alfa PDUFA date April 5, 2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Q4 2025 net loss $128.5M vs $114.8M in Q4 2024; full year net loss $512.5M vs $422.8M in 2024.","PDUFA target action date for tividenofusp alfa (Hunter syndrome) BLA is April 5, 2026; commercial launch readiness established.","Preliminary Phase 1/2 data for DNL126 (Sanfilippo syndrome type A) support accelerated approval path; global Phase 3 planning ongoing.","Cash, cash equivalents and marketable securities as of Dec 31, 2025 were approximately $966.2M.","In December 2025, raised $275M synthetic royalty from Royalty Pharma and ~$200M net from public offering."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.97,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2025-FY","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":107666,"accession_number":"0001714899-26-000004","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2026-01-06T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Denali outlines 2026 milestones: PDUFA April 5 for Hunter syndrome, multiple pipeline readouts","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Preparing for commercial launch of tividenofusp alfa (Hunter syndrome) with PDUFA target action date April 5, 2026; results published in NEJM.","Expect multiple clinical data readouts: Phase 1/2 DNL126 for Sanfilippo type A, Phase 1/2 DNL593 for FTD-GRN, Phase 2b LUMA for Parkinson's (BIIB122).","Initiate Phase 1b for DNL628 (OTV:MAPT) in Alzheimer's; FDA lifted clinical hold on DNL952 for Pompe disease; Phase 1 start.","Completed equity financing (~$200M gross) and royalty funding from Royalty Pharma up to $275M; cash as of Sep 30, 2025: ~$872.9M.","Partnerships: Biogen (Parkinson's, 50/50 US), Takeda (FTD-GRN, 50/50 US), Sanofi (RIPK1 inhibitor in UC, royalties)."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":124038,"accession_number":"0001628280-25-056363","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-12-10T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Denali prices $200M public offering of common stock and pre-funded warrants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Prices 9.14M shares at $17.50 and 2.29M pre-funded warrants at $17.49, raising ~$200M gross proceeds.","Underwriters granted 30-day option for additional 1.71M shares, potential total $230M gross proceeds.","Offering expected to close Dec 11, 2025; Goldman Sachs, J.P. Morgan, Morgan Stanley, Jefferies as joint book-runners.","Pre-funded warrants have $0.01 exercise price, immediately exercisable, with 4.99% beneficial ownership limitation."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":124037,"accession_number":"0001714899-25-000209","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-12-04T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Denali pipeline update: DNL952 on clinical hold; PDUFA date Apr 2026 for Hunter syndrome","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["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.","DNL126 (MPS IIIA) Phase 1/2 on track for completion 2026; potential accelerated approval and commercial launch by end of 2027. Initial data at 2026 WORLD Symposium.","IND for DNL952 (Pompe) placed on clinical hold; FDA requested protocol amendments (lower starting dose, revised inclusion criteria). Denali has responded, minimal delays expected.","Phase 1b study of DNL628 (Alzheimer's) expected to begin 1H 2026; CTA submitted. Regulatory submission for DNL921 planned 1H 2026.","BIIB122 (Parkinson's) Phase 2b readout expected 2026. Eclitasertib (ulcerative colitis) Phase 2 data expected 1H 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":124036,"accession_number":"0001714899-25-000208","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-12-04T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"Denali secures $275M royalty funding from Royalty Pharma on tividenofusp alfa","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Royalty Pharma pays $200M at close conditional on FDA accelerated approval by June 30, 2026.","Additional $75M due upon EMA approval by Dec 31, 2029; royalty rate 9.25% on worldwide net sales.","Royalty ceases at 3.0x multiple (2.5x if reached by Q1 2039); Denali retains full rights.","PDUFA target date for tividenofusp alfa BLA is April 5, 2026; MPS II (Hunter syndrome) therapy.","Denali CFO states funds advance platform and launch preparation without dilution."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":124035,"accession_number":"0001714899-25-000192","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-11-06T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali Q3 net loss $126.9M; tividenofusp alfa PDUFA extended to April 2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $126.9M vs $107.2M in Q3 2024; cash $872.9M at Sept 30, 2025.","FDA extended PDUFA date for tividenofusp alfa BLA from Jan 5 to April 5, 2026; no new data requested.","Completed enrollment in Phase 1/2 study of DNL126 for MPS IIIA; planning global confirmatory study.","Submitted CTA for DNL628 (Alzheimer's) and IND for DNL952 (Pompe); new pipeline programs.","CMO Carole Ho departing; Peter Chin appointed Acting CMO; Tim Van Hauwermeiren joins Board."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.24,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":124034,"accession_number":"0001714899-25-000180","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-10-14T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"FDA extends Denali's PDUFA date for tividenofusp alfa to April 5, 2026","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA extended PDUFA target date from Jan 5 to April 5, 2026 for tividenofusp alfa BLA for Hunter syndrome.","Extension follows submission of updated clinical pharmacology info; FDA classified as Major Amendment.","Denali states extension not related to efficacy, safety, or biomarkers; no additional data requested.","Denali continues preparing for potential approval and commercial launch of tividenofusp alfa."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":140709,"accession_number":"0001714899-25-000167","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-08-11T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali Q2 net loss $124M; FDA priority review for Hunter syndrome BLA, DNL126 accelerated path aligned","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["FDA accepted tividenofusp alfa BLA for priority review; PDUFA target action date January 5, 2026.","FDA agreed CSF HS may be surrogate endpoint for accelerated approval of DNL126 in Sanfilippo syndrome; Phase 1/2 nearing completion.","Net loss $124.1M for Q2 2025 vs $99.0M in Q2 2024; R&D expenses $102.7M vs $91.4M.","Cash, cash equivalents, and marketable securities $977.4M as of June 30, 2025.","Preclinical ATV:Abeta data published in Science; company on track to file 1-2 IND applications in 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":140708,"accession_number":"0001714899-25-000146","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-07-07T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"FDA accepts Denali's BLA for tividenofusp alfa with Priority Review; PDUFA Jan 5, 2026","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA grants Priority Review for BLA seeking accelerated approval of tividenofusp alfa for Hunter syndrome (MPS II).","PDUFA target action date set for January 5, 2026.","Tividenofusp alfa is designed to deliver IDS enzyme across the blood-brain barrier using TransportVehicle platform.","BLA supported by Phase 1/2 data from 47 participants; ongoing Phase 2/3 COMPASS study for global approvals.","If approved, would be first new enzyme replacement therapy for Hunter syndrome in nearly two decades."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":158438,"accession_number":"0001714899-25-000128","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-06-03T23:59:59+00:00","items":["1.01","5.07","9.01"],"status":"ready","headline":"Denali Therapeutics elects Julian Baker as director; grants registration rights to Baker Brothers funds","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Julian C. Baker elected as Class II director; 98.0M votes for, 22.9M withheld.","Registration rights agreement with BBA Funds grants resale registration rights; company must file S-3 within 60 days of request.","Ratified Ernst & Young as independent auditor for FY2025; advisory say-on-pay approved with 90.2% of shares represented."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":158437,"accession_number":"0001714899-25-000104","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-05-06T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali completes BLA submission for Hunter syndrome; Q1 net loss widens to $133M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $133.0M in Q1 2025 vs $101.8M in Q1 2024; R&D expense rose to $116.2M.","Cash and marketable securities $1.05B as of March 31, 2025.","BLA for tividenofusp alfa (Hunter syndrome) submitted under FDA accelerated approval pathway.","Phase 2b LUMA study for BIIB122 (Parkinson's) fully enrolled; readout expected in 2026.","G&A expenses increased to $29.4M from $25.2M, driven by BLA submission and launch prep."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.78,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":158436,"accession_number":"0001714899-25-000077","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-04-02T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Denali initiates rolling BLA submission for tividenofusp alfa (Hunter syndrome); launch targeted late 2025/early 2026","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Rolling BLA for accelerated approval of tividenofusp alfa (MPS II) initiated; FDA aligned on CSF HS as surrogate endpoint.","BLA submission expected to complete in first half of May 2025.","Potential U.S. commercial launch in late 2025 or early 2026.","FDA collaboration under START program for accelerated development path of DNL126 (Sanfilippo syndrome).","Productive engagement with CDER on full approval conversion path for tividenofusp alfa."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":176800,"accession_number":"0001714899-25-000072","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-03-05T23:59:59+00:00","items":["7.01"],"status":"ready","headline":"Further analyses of DNL343 in ALS show no NfL treatment effect; extension discontinued","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Further analyses of Regimen G DNL343 showed no treatment effect on neurofilament light (NfL) biomarker over 24-week double-blind period.","A subset completing additional 28-week open-label extension also showed no NfL effect.","On Jan 6, 2025, Denali announced study did not meet primary endpoint of slowing ALS progression.","Key secondary endpoints also not statistically different; active treatment extension for Regimen G discontinued.","DNL343 safe and well tolerated; data to be presented at future medical meeting; future development assessed."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":176799,"accession_number":"0001714899-25-000067","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-02-27T23:59:59+00:00","items":["1.01","1.02","2.02","9.01"],"status":"ready","headline":"Denali reports FY2024 net loss $422.8M; BLA for MPS II drug planned early 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $114.8M Q4 and $422.8M FY2024, vs $119.5M and $145.2M in prior year.","No collaboration revenue in 2024; FY2023 had $330.5M from Biogen, Sanofi, Takeda.","New ATM equity facility up to $400M; prior ATM terminated; Goldman & Leerink agents.","DNL343 (ALS) missed primary endpoint in HEALEY trial; further analyses expected H2 2025.","2025 cash opex guided +10-15% vs 2024; cash balance $1.19 billion as of Dec 31."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.57,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2024-FY","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":176798,"accession_number":"0001714899-25-000054","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-01-13T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Denali tividenofusp alfa gets FDA Breakthrough Therapy; BLA submission in early 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["FDA granted Breakthrough Therapy Designation for tividenofusp alfa in Hunter syndrome (MPS II) on Jan 7, 2025.","Denali expects BLA submission under accelerated approval pathway in early 2025; U.S. launch targeted late 2025/early 2026.","Seeking FDA alignment on accelerated approval for DNL126 in Sanfilippo syndrome after CSF HS normalization in Phase 1/2.","Cash, equivalents, and marketable securities ~$1.28B as of Sep 30, 2024; cash runway extended into 2028.","Plan to advance 1–2 TV-enabled programs into clinic per year over next three years across ETV, OTV, ATV."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":176797,"accession_number":"0001714899-25-000007","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2025-01-07T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Denali's DNL343 fails Phase 2/3 ALS trial; primary endpoint not met","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Primary endpoint of ALSFRS-R and survival at 24 weeks not met vs placebo.","Key secondary endpoints (muscle strength, respiratory function) also not statistically different.","DNL343 was safe and well tolerated overall.","Additional analyses including NfL biomarkers and subgroup data expected later in 2025.","Trial enrolled 186 DNL343-treated vs 139 placebo participants."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":193616,"accession_number":"0001714899-24-000233","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-11-18T23:59:59+00:00","items":["5.03","9.01"],"status":"ready","headline":"Denali Therapeutics amends bylaws for universal proxy and Delaware law updates","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Board approved amended restated bylaws effective November 12, 2024.","Updates advance notice procedures for director nominations and stockholder proposals.","Requires stockholder to show Rule 14a-19 compliance 5 business days before meeting.","Conforms provisions to current Delaware General Corporation Law.","Updates provisions on directors, board committees, officers, and ministerial changes."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.2,"calibrated_materiality_score":0.2,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":193615,"accession_number":"0001714899-24-000215","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-11-06T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali Q3 net loss $107.2M; tividenofusp BLA planned early 2025; DNL126 shows biomarker reduction","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $107.2M vs $99.4M YoY; no collaboration revenue; cash $1.28B at Sep 30, 2024.","Updated 2024 cash opex guidance: +5-10% vs 2023 (prior: ≤2023) due to BLA prep and commercial readiness.","Tividenofusp alfa (MPS II): FDA agrees CSF HS as surrogate endpoint; BLA submission on track for early 2025.","DNL126 (MPS IIIA): preliminary data show CSF HS reduction and normalization; study expanded for accelerated path.","SAR443820/DNL788 (MS): Sanofi's K2 Phase 2 discontinued after missing primary and key secondary endpoints."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.89,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":193614,"accession_number":"0001714899-24-000205","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-10-10T23:59:59+00:00","items":["7.01"],"status":"ready","headline":"Denali partner Sanofi discontinues K2 Phase 2 study of oditrasertib in MS after missing endpoints","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Sanofi discontinued K2 Phase 2 study of oditrasertib (SAR443820/DNL788) in multiple sclerosis.","Study did not meet primary and key secondary endpoints based on serum neurofilament light chain levels.","Denali was informed by partner Sanofi; no further details on safety or next steps provided."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":209915,"accession_number":"0001714899-24-000168","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-08-01T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali Q2 net loss $99M; FDA open to accelerated approval for DNL310; regains ATV:Abeta rights","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $99.0M in Q2 2024 vs $183.4M net income in Q2 2023; no collaboration revenue versus $294.1M last year.","Cash and marketable securities $1.35B as of June 30, 2024.","FDA CDER open to discussing accelerated approval for DNL310 (MPS II) using CSF HS as surrogate biomarker.","Biogen terminated ATV:Abeta license; Denali regains all rights; decision not related to efficacy or safety.","DNL126 (MPS IIIA) selected for FDA START pilot program; Phase 1/2 data expected by end of 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.26,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2024-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":228113,"accession_number":"0001714899-24-000125","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-05-31T23:59:59+00:00","items":["5.07","9.01"],"status":"ready","headline":"Denali shareholders elect directors, ratify auditor, approve executive compensation","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Three Class I directors elected: Jay Flatley (108.1M for), Mac Tessier-Lavigne (82.2M for), Nancy Thornberry (108.3M for).","Ernst & Young ratified as auditor for FY2024 with 118.0M for, 297k against.","Say-on-pay advisory vote passed with 101.6M for, 8.6M against.","Meeting had 83.0% of outstanding shares present (118.3M of 142.5M shares)."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.2,"calibrated_materiality_score":0.15,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":228112,"accession_number":"0001714899-24-000120","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-05-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali Q1 net loss $101.8M, cash $1.43B; reports pipeline progress and $500M PIPE","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $101.8M vs $109.8M YoY; zero collaboration revenue vs $35.1M in Q1 2023.","R&D expense $107.0M, down from $128.8M; G&A $25.2M, down from $27.1M.","Completed $500M PIPE financing in February; raised cash to $1.43B.","Tividenofusp alfa (MPS II) shows sustained biomarker normalization; FDA may consider accelerated path.","Phase 1/2 for DNL126 (MPS IIIA) dosed; Phase 2/3 COMPASS enrollment expected to complete in 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.68,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2024-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":246879,"accession_number":"0001714899-24-000076","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-02-27T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Denali reports Q4 net loss $119.5M, announces ~$500M PIPE and spin-out of preclinical small molecules","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["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).","PIPE financing of ~$500M gross proceeds: 3.24M shares and 26.05M pre-funded warrants at ~$17.07 per unit; cash runway into 2028.","Plans to spin out preclinical small molecule portfolio to focus on TV-enabled platforms; CD98hc TV platform announced.","Phase 2/3 COMPASS (MPS II) and HEALEY ALS (DNL343) enrollment expected to complete in 2024.","SAR443820/DNL788 (RIPK1) missed ALS Phase 2 HIMALAYA primary endpoint; ongoing MS Phase 2 unaffected."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":246878,"accession_number":"0001714899-24-000075","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-02-27T23:59:59+00:00","items":["1.01","3.02","7.01","9.01"],"status":"ready","headline":"Denali raises $500M via PIPE at $17.07/share, adds pre-funded warrants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Gross proceeds of ~$500M from 3.2M shares at $17.07 and 26M pre-funded warrants at $17.06.","Proceeds to fund R&D, accelerate BBB-crossing Transport Vehicle technology, and working capital.","Lead investor is a U.S. healthcare-focused fund; close expected Feb 29, 2024.","Post-close estimated cash, equivalents, and investments ~$1.5B.","Investor with >10% ownership can appoint one board nominee under nominating agreement."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":246877,"accession_number":"0001714899-24-000065","cik":1714899,"company_name":"Denali Therapeutics Inc.","ticker":"DNLI","form_type":"8-K","filed_at":"2024-02-16T23:59:59+00:00","items":["7.01"],"status":"ready","headline":"Denali partner Sanofi reports Phase 2 ALS trial miss for RIPK1 inhibitor DNL788","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Phase 2 HIMALAYA study of SAR443820/DNL788 in ALS did not meet primary endpoint (ALSFRS-R).","Sanofi will present detailed efficacy and safety results at a future scientific forum.","DNL788 is an oral brain-penetrant RIPK1 inhibitor co-developed by Sanofi and Denali.","Sanofi will continue the K2 Phase 2 study of DNL788 in multiple sclerosis.","No financial terms disclosed; pipeline setback for Denali's key partnership."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":3224981609.737754,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}