Denali Therapeutics (DNLI)
Develops brain-penetrating therapies and commercializes AVLAYAH for Hunter syndrome.
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Commercializes AVLAYAH for neurologic manifestations of Hunter syndrome and develops TransportVehicle-enabled therapies for lysosomal storage and neurodegenerative diseases. U.S. product sales are emerging alongside a clinical pipeline dependent on trial results, regulatory decisions, manufacturing, and selected collaborations.
Commercializes AVLAYAH in the United States for neurologic manifestations of Hunter syndrome and develops therapies for lysosomal storage, neurodegenerative, and inflammatory diseases. AVLAYAH uses Enzyme TransportVehicle technology to deliver its enzyme throughout the body, including across the blood-brain barrier.
The pipeline applies related delivery formats through DNL126 for Sanfilippo syndrome, DNL952 for Pompe disease, DNL593 for frontotemporal dementia, and DNL628 for Alzheimer's disease; eclitasertib targets ulcerative colitis through a separate approach. Work combines biomarker-guided trials, biologics manufacturing, and commercialization. DNL593 returned to sole control after Takeda ended its collaboration.
AVLAYAH commercialization is U.S.-centered, while its COMPASS confirmatory study spans the Americas and Europe. Continued approval may depend on verification of clinical benefit; the pipeline depends on trial results, regulatory review, manufacturing, partners, and financing.
Company facts
Target rangeAs of Sep 22, 2026
Latest analyst notes
| Date | Firm | Action | Prior | Current |
|---|---|---|---|---|
| Aug 7, 2026 | UBS | Reiterate | Rating: —Target: $25 | Target: $34 |
| Aug 7, 2026 | Robert W. Baird | Target | Target: — | Target: $34 |
| Jul 23, 2026 | Morgan Stanley | Reiterate | Rating: —Target: $35 | Target: $36 |
| Jul 13, 2026 | Wedbush | Reiterate | Rating: —Target: $23 | Target: $26 |
| Jun 22, 2026 | Stifel Nicolaus | Target | Target: $37 | Target: $41 |
EPSReportedEstimate
RevenueReportedEstimate
Balance sheet, Jun 30, 2026Cash & short-term investments $710.5M · Total debt $27.5M · Total assets $1.16B · Shareholders' equity $835.2M
- Revenue
- $3.6M
- Operating income
- −$130.5M
- Net income
- −$127.6M
No dividends on record.
| Institutions | 98.52% | 157.48M shares | |
|---|---|---|---|
| 302 holders · as of Jun 30, 2026 | |||
| Insiders | 7.04% | 11.26M shares | |
| 13 holders · as of Sep 9, 2026 | |||
| Adds to | 105.56% | ||
159.85M company shares as of Sep 23, 2026 · institutions as of Jun 30, 2026 · holders as of their latest filing
These groups come from separate filings that can overlap, so they add to 105.56%; nothing is left for Other.
Top shareholders13F · 13D/G · Form 4
| Holder | Stake | Shares | Date |
|---|---|---|---|
T. Rowe Price Investment Management, Inc.Institution | 10.12% | 16.18M | as of Jun 30, 2026 |
BlackRock, Inc.Institution | 8.77% | 14.03M | as of Jun 30, 2026 |
Baillie Gifford & CoInstitution | 7.48% | 11.96M | as of Jun 30, 2026 |
Douglas K. Bratton1Insider10 percent owner | 4.91% | 7.85M | filed Feb 14, 2022 |
State Street CorpInstitution | 4.41% | 7.05M | as of Jun 30, 2026 |
- Douglas K. Bratton's own ownership statement (13G/A, Feb 14, 2022) reports fewer shares than the transaction reports; the statement is used.
Insider tradesForm 4
| Date | Insider | Role | Shares | Avg price |
|---|---|---|---|---|
| Sep 4, 2026 | Peter Scott Chin | officer: Chief Medical Officer | −1,654 | $22.29 |
| Sep 2, 2026 | Nancy Thornberry | director | −11,439 | $22.90 |
| Sep 1, 2026 | Alexander O. Schuth | officer: COFO and Secretary | −2,768 | $23.44 |
| Aug 11, 2026 | Alexander O. Schuth | officer: COFO and Secretary | −2,857 | $25.07 |
| Jan 6, 2026 | Alexander O. Schuth | officer: COFO and Secretary | −17,218 | $16.50 |
- Takeda (ADR)
Incumbent systemic Hunter syndrome ERT benchmark
- REGENXBIO
Late-stage one-time gene therapy threat in MPS II
- Ultragenyx Pharmaceutical
Direct MPS IIIA gene therapy comparator
- BioMarin
Broad rare-disease enzyme incumbent across MPS disorders
- Sanofi (ADR)
Large rare-disease franchise in Pompe and other LSDs
Compare
| Company | Price | Change | |||||
|---|---|---|---|---|---|---|---|
| Denali Therapeutics | $20.66 | −4.35% | $3.43B | — | — | 951.2 | — |
| Takeda (ADR) | $18.88 | −0.40% | $60.30B | 52.9 | 60.0 | 2.0 | +4.2% |
| REGENXBIO | $7.73 | −5.13% | $421.3M | — | — | 2.4 | +405.7% |
| Ultragenyx Pharmaceutical | $14.78 | −5.35% | $1.54B | — | — | 2.1 | +28.5% |
| BioMarin | $62.22 | −1.82% | $12.25B | 162.5 | 10.1 | 3.6 | +20.0% |
| Sanofi (ADR) | $41.63 | −2.07% | $102.08B | 76.0 | — | 1.8 | +11.2% |
| Median | 76.0 | 35.1 | 2.1 | +20.0% |