Name in SEC filings: Denali Therapeutics Inc.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| tividenofusp alfa (DNL310) | target date (company stated) | PDUFA | April 5, 2026 | SEC filing · |
| DNL628 | /data readout | Stage not stated | 2027 | 8-K · |
| DNL593 | Topline/data readout | Stage not stated | 2027 | EX-99.1 · |
| DNL921 | Topline/data readout | Phase 1 | 2027 | EX-99.1 · |
| DNL952 | Topline/data readout | Stage not stated | 2027 | EX-99.1 · |
| zafinofusp alfa / DNL126 | submission | — | 2027 | 8-K · |
Source: ORION, orionbiotechai.com/company/DNLI, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/DNLI
DNL628 · Topline/data readout · 1H 2027
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
Hunter syndrome
PDUFA target date (company stated)April 5, 2026
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $1,100,000,000 · as of · SEC filing
Prescription Drug User Fee Act (PDUFA) target action date of April 5, 2026
SEC filing · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-04)
Topline/data readout1H 2027
Stage: Not stated
Public float: $1,100,000,000 · as of · SEC filing
Denali expects data from this study in 1H 2027.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-06)
Topline/data readout2027
Stage: Not stated
Public float: $1,100,000,000 · as of · SEC filing
Denali now expects results from the study in 2027
EX-99.1 · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
Topline/data readout2027
Stage: Phase 1SEC filing · “Phase 1/1b”
Public float: $1,100,000,000 · as of · SEC filing
clinical proof-of-concept data from the ongoing Phase 1/1b study of DNL921 in healthy volunteers and participants with Alzheimer's disease are expected in 2027
EX-99.1 · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
Topline/data readout2027
Stage: Not stated
Public float: $1,100,000,000 · as of · SEC filing
initial clinical data are expected in 2027
EX-99.1 · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
NDA/BLA submission2027
Stage: —
Public float: $1,100,000,000 · as of · SEC filing
Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for zafinofusp alfa for Sanfilippo syndrome type A in 2027.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| DNL593Clinical results | 2027“Denali now expects results from the study in 2027” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| DNL921Clinical results | 2027“clinical proof-of-concept data from the ongoing Phase 1/1b study of DNL921 in healthy volunteers and participants with Alzheimer's disease are expected in 2027” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| DNL952Clinical results | 2027“initial clinical data are expected in 2027” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| zafinofusp alfa / DNL126Submission | 2027“Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for zafinofusp alfa for Sanfilippo syndrome type A in 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| DNL593Clinical results | end of 2026“Phase 1/2 study of DNL593, including biomarker results, are expected by the end of 2026” Filed · 10-Q | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| DNL593Clinical results | end of 2026“FTD- GRN and expects results by the end of 2026” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| DNL593Clinical results | end of 2026“FTD- GRN , and results are expected by the end of 2026” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| DNL628Clinical results | 1H 2027“Denali expects data from this study in 1H 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| zafinofusp alfa / DNL126Submission | 2027“Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for DNL126 for Sanfilippo syndrome type A in 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| DNL593Clinical results | end of 2026“Phase 1/2 study of DNL593, including biomarker results, are expected by the end of 2026” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| tividenofusp alfa (DNL310)FDA decision | April 5, 2026“Prescription Drug User Fee Act (PDUFA) target action date of April 5, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| tividenofusp alfa (DNL310)FDA decision | April 5, 2026“PDUFA date for our lead asset, tividenofusp alfa, is currently April 5, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| DNL593Clinical results | 2026“Initial FTD- GRN patient data are expected in 2026” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| DNL593Clinical results | 2026“Initial FTD- GRN patient data are expected in 2026” Filed · 8-K | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| tividenofusp alfa (DNL310)FDA decision | April 5, 2026“Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| tividenofusp alfa (DNL310)FDA decision | April 5, 2026“PDUFA target date has been extended from January 5, 2026, to April 5, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| tividenofusp alfa (DNL310)FDA decision | April 5, 2026“Prescription Drug User Fee Act (PDUFA) target date was extended from January 5, 2026, to April 5, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| tividenofusp alfa (DNL310)FDA decision | April 5, 2026“Prescription Drug User Fee Act (PDUFA) target date has been extended from January 5, 2026, to April 5, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| tividenofusp alfa (DNL310)FDA decision | April 5, 2026“PDUFA action date from January 5, 2026 to April 5, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.
Historical catalog checked .
No historical announcement trail is retained for this company in this catalog.
Original ClinicalTrials.gov record · Open the selected study
These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.
Coverage and identity checksSuggest an SEC timing statement to add for DNLI. You can include the original filing link in your note. The founder reads each request by hand.
Or email ORION.
See DNLI in the calendar · Review labels and methodology