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Denali Therapeutics Inc.

7 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

Trial resultsDNLIDenaliH2 2026

Denali expects to report results from its Phase 1/2 study of DNL593 (PTV:PGRN) for frontotemporal dementia with granulin mutations in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.

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Entry

DNL593 Phase 1/2 results in FTD-GRN · Clinical trial results (readout / topline data)

Drug

DNL593 (PTV:PGRN)

For

frontotemporal dementia with granulin mutations

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

H2 2026 · the company gave a window, not a day

Source note

Company guidance (Q1 2026 PR): "results are expected by the end of 2026." Note: Takeda terminated the DNL593 co-development collaboration in April 2026.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
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Trial resultsDNLIDenaliH1 2027

Denali expects to report results from its Phase 2a study of DNL151 (BIIB122, LRRK2 inhibitor) for Parkinson's disease in pathogenic LRRK2 variant carriers in the first half of 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.

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Entry

BEACON Phase 2a data for DNL151 in LRRK2-variant Parkinson's disease · Clinical trial results (readout / topline data)

Drug

DNL151 (BIIB122, LRRK2 inhibitor)

For

Parkinson's disease in pathogenic LRRK2 variant carriers

Stage

Phase 2a

When

H1 2027 · the company gave a window, not a day

Source note

Denali continues BEACON independently after the Phase 2b LUMA miss in idiopathic PD (May 2026); BEACON data expected in 1H 2027 per Q2 2026 update.

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Source: investors.denalitherapeutics.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsDNLIDenaliH1 2027

Denali expects to report results from its Early-stage clinical study of DNL628 for Alzheimer's disease in the first half of 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.

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Entry

DNL628 Alzheimer's disease study data · Clinical trial results (readout / topline data)

Drug

DNL628

For

Alzheimer's disease

Stage

Early-stage clinical

When

H1 2027 · the company gave a window, not a day

Source note

Company guidance: "Denali expects data from this study in 1H 2027."

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneDNLIDenali2027

DNL126 BLA submission and potential accelerated approval in Sanfilippo syndrome type A, expected during 2027 (no exact date yet). A company milestone for Denali (DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA)): a step in the program rather than a decision or a data readout.

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Entry

DNL126 BLA submission and potential accelerated approval in Sanfilippo syndrome type A · Company milestone

Drug

DNL126 (ETV:SGSH)

For

Sanfilippo syndrome type A (MPS IIIA)

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

2027 · the company gave a window, not a day

Source note

Company guidance: "Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for DNL126 for Sanfilippo syndrome type A in 2027" (year-level guidance only).

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsDNLIDenali2027

Denali expects to report results from its Phase 1/2 study of DNL593 (PTV:PGRN) for frontotemporal dementia-GRN during 2027 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.

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Entry

DNL593 FTD-GRN Phase 1/2 results pushed to 2027 · Clinical trial results (readout / topline data)

Drug

DNL593 (PTV:PGRN)

For

frontotemporal dementia-GRN

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

2027 · the company gave a window, not a day

Source note

changed date for existing DNLI|readout|2026-H2 DNL593 item. Q2 2026 PR (Aug 6, 2026) moves expected DNL593 FTD-GRN results from end of 2026 to 2027.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsDNLIDenali2027

Denali expects to report results from its Phase 1/2 study of DNL952 (ETV:GAA) for Pompe disease during 2027 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.

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Entry

DNL952 ETV:GAA Pompe disease initial clinical data · Clinical trial results (readout / topline data)

Drug

DNL952 (ETV:GAA)

For

Pompe disease

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

2027 · the company gave a window, not a day

Source note

Q2 2026 PR (Aug 6, 2026): initial clinical data from the DNL952 Pompe program expected in 2027.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsDNLIDenali2027

Denali expects to report results from its Phase 1 study of DNL921 (ATV:Abeta) for Alzheimer's disease during 2027 (no exact date yet). Phase 1 is an early safety study in a small group of people.

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Entry

DNL921 ATV:Abeta Alzheimer's Phase 1/1b safety and proof-of-concept data · Clinical trial results (readout / topline data)

Drug

DNL921 (ATV:Abeta)

For

Alzheimer's disease

Stage

Phase 1 · an early safety study in a small group of people

When

2027 · the company gave a window, not a day

Source note

Q2 2026 PR (Aug 6, 2026): safety and clinical PoC data from the ongoing Phase 1/1b study of DNL921 in Alzheimer's expected in 2027. DNL628 biomarker data (H1 2027) and BEACON DNL151 (H1 2027) already tracked.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Past catalysts

Trial resultsDNLIDenaliMay 21, 2026

Denali reported results from its Phase 2b study of BIIB122 (DNL151) for early-stage Parkinson's disease on May 21, 2026. The study missed its main goal.

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Entry

Phase 2b LUMA missed primary and secondary endpoints; BIIB122 dropped · Clinical trial results (readout / topline data)

Drug

BIIB122 (DNL151)

For

early-stage Parkinson's disease

Stage

Phase 2b

When

May 21, 2026

Source note

Biogen and Denali reported that LRRK2 inhibitor BIIB122 (DNL151) failed to slow progression versus placebo on the primary MDS-UPDRS Part II+III endpoint in 648 early-stage Parkinson's patients, with no benefit on secondaries; the partners discontinued development in idiopathic Parkinson's disease.

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Source: sec.gov ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneDNLIDenaliApr 3, 2026

Takeda terminates DNL593 collaboration; rights revert to Denali, on Apr 3, 2026. A company milestone for Denali (DNL593 (PTV:PGRN) for GRN-related frontotemporal dementia): a step in the program rather than a decision or a data readout.

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Entry

Takeda terminates DNL593 collaboration; rights revert to Denali · Company milestone

Drug

DNL593 (PTV:PGRN)

For

GRN-related frontotemporal dementia

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

Apr 3, 2026

Source note

Denali received notice that Takeda was ending the 2018 co-development/co-commercialization deal for DNL593 (PTV:PGRN) in FTD-GRN for strategic reasons unrelated to efficacy or safety, with all rights reverting to Denali 60 days later.

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Source: sec.gov ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalDNLIDenaliMar 25, 2026

The FDA approved Denali’s AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome (MPS II) on Mar 25, 2026. The company can now sell it in that market.

More details

Entry

FDA grants accelerated approval of AVLAYAH for Hunter syndrome (MPS II) · Regulatory approval

Drug

AVLAYAH (tividenofusp alfa-eknm)

For

Hunter syndrome (MPS II)

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

Mar 25, 2026

Source note

Denali's tividenofusp alfa-eknm became the first FDA-approved brain-penetrant enzyme replacement therapy for neurologic manifestations of MPS II, cleared on a CSF heparan sulfate surrogate endpoint (91% reduction by week 24). A rare pediatric disease priority review voucher came with the approval.

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Source: sec.gov ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
DNLI headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

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