The data are strong and durable, with no new safety signals, supporting a registrational trial in 2027. Monitor FDA alignment updates and any additional data presentations later this year. The stock may re-rate on the reduced clinical risk and clear path to registration.
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Executive Summary
Recursion Pharmaceuticals announced positive updated Phase 2 data from the TUPELO trial of REC-4881 in familial adenomatous polyposis (FAP), presented at a Presidential Plenary at CGA-IGC. The data showed a 47% median reduction in total polyp burden after 12 weeks, with 85% of patients remaining below baseline 12 weeks off treatment, and substantial reductions in larger, higher-risk polyps. The company plans to initiate a registrational trial in the second half of 2027, pending FDA discussions.
Key Facts
- 87% of patients (13 of 15) had reduction in total polyp burden after 12 weeks, with 47% median reduction.
- 85% of patients (11 of 13) remained below baseline 12 weeks off treatment.
- 92% of patients (12 of 13) had upper GI polyp burden reductions, with 55% median reduction; nearly 1 in 2 achieved ≥65% reduction.
- Two patients achieved ≥98% reductions in upper GI polyp burden.
- Six of eight patients with polyps >5 mm at baseline had reductions; four achieved ≥80% reduction.
- No new safety signals; no Grade 4 or 5 TRAEs; 81% of patients had highest-grade TRAE of Grade 1 or 2.
- REC-4881 has FDA Orphan Drug and Fast Track designations.
- Company estimates FAP represents a potential $15 billion opportunity with no approved pharmacologic therapies.
- Registrational trial anticipated to start in second half of 2027, pending FDA discussions.
Financial Impact
FAP is a rare disease with no approved therapies; the company estimates a $15 billion market opportunity. REC-4881 is a key pipeline asset for Recursion (market cap $2.5B). Positive Phase 2 data de-risks the program and supports a registrational path.
Risk Factors
- Data are from a single-arm Phase 1b/2 trial with a small sample size (15 evaluable patients); results may not replicate in a larger, controlled registrational trial.
- Registrational trial initiation is pending FDA discussions; the FDA may require additional data or a different trial design.
- The company has no approved products and will need to fund a registrational trial and potential commercialization; dilution risk exists.
- Comparisons to natural history data are not from a controlled study and may not be predictive.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3393764 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Nov 4, 2026 today | Institutional Cluster | $3.78 | awaiting T+5 | awaiting T+5 | $3.91 (+3.44%) |
Nov 3, 2026 1d ago | 144 | $3.86 | awaiting T+5 | awaiting T+5 | $3.91 (+1.43%) |
Nov 2, 2026 1d ago | 8-K | No price | awaiting T+5 | awaiting T+5 | No price |
Nov 2, 2026 1d ago | Press Release | $3.81 | awaiting T+5 | awaiting T+5 | $3.91 (+2.62%) |
Nov 2, 2026 1d ago | Press Release | $3.83 | awaiting T+5 | awaiting T+5 | $3.91 (+2.17%) |
Nov 2, 2026 1d ago | Press Release | $3.81 | awaiting T+5 | awaiting T+5 | $3.91 (+2.62%) |
Oct 15, 2026 19d ago | 424B5 | $3.47 $3.58 | ▼ −3.32% | ▼ −3.23% | $3.91 (−12.84%) |
Oct 15, 2026 20d ago | 8-K | $4.16 $3.58 | ▼ −13.94% | ▼ −12.93% | $3.91 (−6.01%) |
Oct 15, 2026 20d ago | Press Release | $4.16 $3.58 | ▼ −13.94% | ▼ −12.93% | $3.91 (−6.01%) |
Oct 15, 2026 20d ago | Press Release | $4.16 $3.58 | ▲ +13.94% | ▲ +12.93% | $3.91 (+6.01%) |
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