The dose-dependent efficacy and favorable safety profile support clinical differentiation for muzastotug. With Fast Track status and a clear path to registration, ADAG is positioned for meaningful upside ahead of 2027 Phase 2 data. Traders should monitor enrollment progress and potential interim updates, which could catalyze re-rating.
Price Chart
Executive Summary
Adagene announced updated Phase 1b/2 data for muzastotug in advanced MSS CRC, showing a 31% confirmed ORR at 20 mg/kg—more than double the 13% ORR at 10 mg/kg—along with improved PFS (6.7 vs 4.8 months) and durable responses. The FDA has granted Fast Track designation, and a randomized Phase 2 trial is ongoing with results expected in 1H 2027.
Key Facts
- Muzastotug achieved 31% confirmed ORR in 20 mg/kg cohorts vs 13% at 10 mg/kg in MSS CRC patients without liver metastases
- Median PFS improved to 6.7 months at 20 mg/kg vs 4.8 months at 10 mg/kg; mDOR not reached in 20 mg/kg cohorts
- Median OS not yet reached in 20 mg/kg cohorts; 1-year OS rate of 80.8% vs 70.1% at 10 mg/kg
- Low discontinuation rate (4%), no Grade 4/5 TRAEs; Grade 3 TRAEs manageable at 38% in 20 mg/kg cohorts
- FDA granted Fast Track designation for muzastotug + pembrolizumab in MSS mCRC without liver mets
- Randomized Phase 2 trial ongoing with data readout expected in 1H 2027
Financial Impact
Potential for significant value inflection upon Phase 2 readout; current market cap of $217M may not reflect full optionality of a differentiated CTLA-4 therapy
Risk Factors
- Phase 2 trial may not confirm Phase 1b/2 results, particularly in randomized setting
- Higher Grade 3 TRAEs at 20 mg/kg (38%) could limit dosing in broader populations
- Competitive landscape includes other CTLA-4 and combination immunotherapies in CRC
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3267222 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 25, 2026 4w ago | 6-K | $3.20 | awaiting T+60 | — | $2.49 (−22.19%) |
Sep 22, 2026 4w ago | 6-K | $3.23 | awaiting T+60 | — | $2.49 (−22.91%) |
Sep 10, 2026 6w ago | 6-K | $3.31 | awaiting T+60 | — | $2.49 (−24.77%) |
Sep 9, 2026 6w ago | 6-K | $3.27 | awaiting T+60 | — | $2.49 (−23.85%) |
Aug 16, 2026 10w ago | Institutional Cluster | $3.83 | awaiting T+60 | — | $2.49 (−34.99%) |
Aug 12, 2026 10w ago | 6-K | $3.75 | awaiting T+60 | — | $2.49 (−33.60%) |
Aug 12, 2026 10w ago | Press Release | $3.75 | awaiting T+60 | — | $2.49 (−33.60%) |
Jul 6, 2026 16w ago | 6-K | $3.93 $3.21 | ▼ −18.32% | ▼ −20.04% | $2.49 (−36.64%) |
Apr 17, 2026 27w ago | 6-K | $3.89 $3.67 | ▼ −5.66% | ▼ −12.43% | $2.49 (−35.99%) |
Apr 2, 2026 29w ago | 6-K | $3.99 $4.20 | ▼ −5.26% | ▲ +8.90% | $2.49 (+37.59%) |
US Market Status
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