The strong PASI 100 data positions envudeucitinib as a potential best-in-class oral therapy, de-risking the upcoming NDA filing. Traders should watch for the LUMUS Phase 2b SLE data in Q3 2026 and any FDA acceptance/priority review news following the Q4 NDA submission.
Price Chart
Executive Summary
Alumis reported positive long-term Phase 3 ONWARD3 extension data for envudeucitinib in plaque psoriasis, showing 54% of patients achieved complete skin clearance (PASI 100) at 48 weeks, the highest rate reported among oral therapies. The company remains on track to submit a New Drug Application to the FDA in Q4 2026. This is a clinical data readout with no financial figures, and the positive efficacy/safety profile supports the NDA filing catalyst, but approval and commercial uptake remain uncertain.
Key Facts
- ONWARD3 long-term extension data: 54% of patients achieved PASI 100 (complete skin clearance) at 48 weeks of continuous envudeucitinib treatment.
- 75% of patients achieved PASI 90 at 48 weeks.
- 1,509 patients rolled over from ONWARD1/2 into ONWARD3 (>85% rollover rate).
- Safety profile remained consistent with prior data; no new safety signals observed.
- Company on track to submit NDA to FDA for envudeucitinib in moderate-to-severe plaque psoriasis in Q4 2026.
- Topline data from LUMUS Phase 2b trial in systemic lupus erythematosus expected in Q3 2026.
Financial Impact
No financial figures reported. Positive clinical data supports NDA filing and potential future revenue from envudeucitinib, but no revenue or earnings data in filing.
Risk Factors
- FDA may not accept or approve the NDA; regulatory risk remains.
- Competitive landscape includes existing oral therapies (apremilast, deucravacitinib) and emerging TYK2 inhibitors.
- No revenue or profitability data in filing; company is pre-commercial with no approved products.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-093353 |
| Document: tm2622655d1_ex99-1.htm | 0001104659-26-093353 |
| Document: 0001104659-26-093353-index-headers.html | 0001104659-26-093353 |
| Document: 0001104659-26-093353-index.html | 0001104659-26-093353 |
| Document: 0001104659-26-093353.txt | 0001104659-26-093353 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 9, 2026 6w ago | Insider Buy | $9.90 $9.18 | ▼ −7.27% | ▼ −8.13% | $6.62 (−33.13%) |
Sep 1, 2026 7w ago | 8-K | $9.47 $10.35 | ▲ +9.29% | ▲ +8.85% | $6.62 (−30.10%) |
Aug 15, 2026 10w ago | Institutional Cluster | $25.50 $24.88 | ▼ −2.43% | ▼ −1.76% | $6.62 (−74.04%) |
Aug 10, 2026 10w ago | 8-K | $25.37 $25.55 | ▲ +0.71% | ▲ +0.46% | $6.62 (−73.91%) |
Aug 5, 2026 11w ago | Insider Cluster | $27.80 $27.60 | ▼ −0.72% | ▼ −1.33% | $6.62 (−76.19%) |
Aug 5, 2026 11w ago | Insider Cluster | $27.80 $27.60 | ▼ −0.72% | ▼ −1.33% | $6.62 (−76.19%) |
Jun 29, 2026 17w ago | 8-K | $27.14 $28.14 | ▲ +3.68% | ▲ +2.91% | $6.62 (−75.61%) |
Jun 11, 2026 19w ago | Institutional Cluster | $20.90 $24.15 | ▲ +15.55% | ▲ +15.01% | $6.62 (−68.33%) |
May 18, 2026 22w ago | DEFA14A | $21.53 $22.04 | ▲ +2.39% | ▲ +1.35% | $6.62 (−69.25%) |
Mar 28, 2026 30w ago | Press Release | $20.21 $22.03 | ▲ +9.01% | ▲ +6.11% | $6.62 (−67.24%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers