Denali Therapeutics
Develops brain-penetrating therapies and commercializes AVLAYAH for Hunter syndrome.
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Profile
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
Key statistics
Year to date +47.4% · Average volume (30d) 1.3M
Analysts
Ratings
Target range
Latest analyst notes
| Date | Firm | Action | Rating | Prior target | Target |
|---|---|---|---|---|---|
| Aug 7, 2026 | UBS | Reiterate | Buy | $25 | $34 |
| Aug 7, 2026 | Robert W. Baird | Target | $34 | ||
| Jul 23, 2026 | Morgan Stanley | Reiterate | Overweight | $35 | $36 |
| Jul 13, 2026 | Wedbush | Reiterate | Outperform | $23 | $26 |
| Jun 22, 2026 | Stifel Nicolaus | Target | $37 | $41 |
Earnings
EPS
Revenue
History
| Report date | EPS est | EPS | Surprise | Revenue est | Revenue | Surprise | Next session |
|---|---|---|---|---|---|---|---|
| Aug 6, 2026Q2 FY26 | −$0.51 | −$0.68 | −32.5% | $2.2M | $3.6M | +67.3% | +0.40% |
| May 7, 2026Q1 FY26 | −$0.73 | −$0.69 | +5.5% | $2.6M | — | — | −0.46% |
| Feb 26, 2026Q4 FY25 | −$0.75 | −$0.73 | +2.7% | $3.1M | — | — | −1.12% |
| Nov 6, 2025Q3 FY25 | −$0.76 | −$0.74 | +2.6% | $2.9M | — | — | +4.23% |
Financial highlights
| 12 quarters | Q1 FY25 | Q2 FY25 | Q3 FY25 | Q4 FY25 | Q1 FY26 | Q2 FY26 | |
|---|---|---|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 | $0 | $3.6M | |
| Gross profit | $0 | $0 | $0 | −$2.9M | −$2.8M | $3.5M | |
| Operating income | −$145.6M | −$135.0M | −$137.4M | −$137.4M | −$137.4M | −$130.5M | |
| Net income | −$133.0M | −$124.1M | −$126.9M | −$128.5M | −$128.4M | −$127.6M | |
| Diluted EPS | −$0.78 | −$0.72 | −$0.74 | −$0.73 | −$0.69 | −$0.68 | |
| Gross margin | — | — | — | — | — | 97.4% | |
| Operating margin | — | — | — | — | — | -3,622.1% |
Fiscal years (4-quarter sums)FY21 $48.7M · FY22 $108.5M · FY23 $330.5M · FY24 $0 · FY25 $0
Balance sheet, Jun 30, 2026Cash & short-term investments $710.5M · Total debt $27.5M · Total assets $1.16B · Shareholders' equity $835.2M
Dividends
No dividends on record.
Ownership
A 13F quarter can total more than the shares outstanding — sub-advisers file the same block twice, and a filer's own share count can be a quarter stale. No split is drawn from it.
Shares outstanding 158.71M · Float 148.71M · 93.7% free float
Top shareholders13F · 13D/G · Form 4
| Holder | Shares | % outstanding | Form | Filed |
|---|---|---|---|---|
| T. Rowe Price Investment Management, Inc. | 16.18M | 10.19% | 13F | Aug 14, 2026 |
| BlackRock, Inc. | 14.03M | 8.84% | 13F | Aug 7, 2026 |
| Baillie Gifford & Co | 11.96M | 7.54% | 13F | Aug 6, 2026 |
| State Street Corp | 7.05M | 4.44% | 13F | Aug 7, 2026 |
| Temasek Holdings (Private) Ltd | 7.01M | 4.42% | 13F | Aug 7, 2026 |
Insider tradesForm 4
| Date | Insider | Role | Shares | Avg price |
|---|---|---|---|---|
| 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 |
| Jan 6, 2026 | Ryan J. Watts | director, officer: President and CEO | −35,198 | $16.50 |
| Dec 11, 2025 | Baker Bros. Advisors LP | director | +2,285,714 | $0.0100 |
Peers
- 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
CompareAfter-hours close
| Company | Price | Change | |||||
|---|---|---|---|---|---|---|---|
| Denali Therapeutics | $24.00 | +0.04% | $3.81B | — | — | 1,056.9 | — |
| Takeda (ADR) | $18.49 | +2.53% | $57.37B | 51.0 | 53.7 | 2.0 | +5.8% |
| REGENXBIO | $9.65 | −0.21% | $499.4M | — | — | 2.9 | +405.7% |
| Ultragenyx Pharmaceutical | $25.68 | +0.27% | $2.52B | — | — | 3.5 | +28.5% |
| BioMarin | $64.67 | +0.02% | $12.50B | 165.8 | 10.4 | 3.7 | +19.9% |
| Sanofi (ADR) | $44.83 | +0.02% | $107.62B | 78.9 | — | 1.9 | +11.2% |
| Median | 78.9 | 32.0 | 2.9 | +19.9% |