← Denali Therapeutics Inc. (DNLI) — catalysts, pipeline & price
Catalyst Dossier · compiled by CeliA 🧫
Denali Therapeutics Inc. (DNLI)
Biological Products, (No Diagnostic Substances) · market cap $3.3B · as of 2026-07-14
Research and calibrated estimates, not financial advice — verify before acting.
Next catalyst
2026-11-05 (est.)
Earnings
Pipeline
5
programs
Upcoming events
3
next 90d+
Dossier
Ready
cached
Denali Therapeutics (DNLI) is a clinical-stage biotech focused on neurological and lysosomal storage diseases, with a market cap of ~$4.1B and 517 employees. Its lead asset, idursulfase, is in Phase 3 for Mucopolysaccharidosis II (MPS II), and a recent July 7, 2026 PDUFA resulted in an approval — the nature and scope of which will drive near-term narrative. The company carries $387.6M in cash against a runway of only ~8.9 months, creating a financing overhang alongside genuine clinical optionality across its pipeline.
The catalyst path
- 2026-11-05 (est.)Earningsimp 5/10
- 2026-12-15 (est.)Phase 2 · DNL593imp 7/10
- 2027-03-15 (est.)Phase 2 · BIIB122 225 mgimp 7/10
Pipeline
| Asset | Phase | Indication |
|---|---|---|
| idursulfase | Phase 3 | Mucopolysaccharidosis II |
| tividenofusp alfa | Phase 3 | Mucopolysaccharidosis II |
| DNL126 | Phase 2 | Mucopolysaccharidosis Type IIIA |
| DNL593 | Phase 2 | Frontotemporal Dementia |
| BIIB122 225 mg | Phase 2 | Parkinson Disease |
Price & technical context
3-month
-21.4%
6-month
-2.1%
12-month
+35.6%
52-wk range
$14.41–$27.21
vs 50-day MA
-11.6%
vs 200-day MA
-4.0%
Realized vol
56.0%
Max drawdown
-63.7%
Daily closes through 2026-10-02. Realized vol annualized; max drawdown over ~2 years.
The full dossier is a Pro feature
Thesis, bull & bear, the if-approved scenario, financials, smart-money signals and risks — compiled by CeliA. The catalyst path & pipeline above are free.
Sources & data
- SEC filings — EDGAR filings for DNLI (10-K, 10-Q, S-3, 13D/G, Form 4)
- Clinical trials — 5 registered trials on ClinicalTrials.gov (per-trial NCT links in the pipeline)
- Market & financial data — SEC EDGAR (XBRL filings, Form 4), Yahoo Finance, Nasdaq — prices, statements, key metrics, insider & institutional filings.
- Regulatory — openFDA, FDA advisory & PDUFA calendars.
Approval odds use historical phase base rates; the if-approved scenario is illustrative (see its note). Figures trace to the sources above — verify before acting.
Data from CatalystAlert (ClinicalTrials.gov, SEC EDGAR, openFDA, market-data providers). Compiled by CeliA. Not financial advice.