The strong efficacy and safety data, combined with FDA alignment on Phase 3 design, substantially reduce regulatory risk for zolucatetide. Key catalysts to watch: initiation of PEDESTAL Phase 3 trial in H1 2027 and any additional data readouts from the ongoing Phase 1/2 in other Wnt-driven indications (FAP, ACP, HCC).
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Executive Summary
Parabilis Medicines reported updated Phase 1/2 data for zolucatetide in desmoid tumors at ESMO 2026, showing a 72.2% objective response rate and 100% disease control rate at the selected Phase 3 dose. The company also announced FDA alignment on dose, placebo-controlled design, and PFS as primary endpoint for the planned PEDESTAL Phase 3 trial, expected to start in H1 2027 with topline data in 2029. These results de-risk the registrational path for a first-in-class β-catenin inhibitor in a defined patient population.
Key Facts
- ORR of 72.2% (13/18) at 32-week landmark in response-evaluable patients starting at ≥450 mg
- Disease control rate of 100% across all 46 response-evaluable patients at ≥450 mg starting dose
- No patients discontinued treatment due to TRAEs; no disease progression observed
- FDA alignment achieved on dose/regimen, placebo-controlled design, and PFS as primary endpoint for Phase 3
- PEDESTAL Phase 3 trial initiation planned for H1 2027; topline results anticipated in 2029
- Zolucatetide has Fast Track and Orphan Drug Designations from FDA for desmoid tumors
- Responses observed irrespective of prior GSI exposure or CTNNB1/APC mutation status
Financial Impact
No financial data provided; clinical-stage company with no approved products or revenue. The positive data and FDA alignment significantly de-risk the registrational path for zolucatetide in desmoid tumors, a market with ~11,000 actively managed patients in the U.S.
Risk Factors
- Interim data based on small sample (18 evaluable at 32 weeks); results may change with longer follow-up
- Phase 3 trial may fail to replicate Phase 1/2 efficacy or safety results
- FDA feedback is non-binding and may change; regulatory path remains uncertain until NDA submission
- Competition from approved gamma-secretase inhibitors (e.g., nirogacestat) and other emerging therapies
- Company is pre-revenue with no approved products; dependent on financing for Phase 3 execution
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3387680 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 24, 2026 3d ago | Press Release | $24.79 | awaiting T+60 | — | $26.51 (+6.94%) |
Oct 19, 2026 8d ago | Press Release | $25.35 | awaiting T+60 | — | $26.51 (+4.58%) |
Sep 15, 2026 6w ago | 8-K | $36.88 | awaiting T+60 | — | $26.51 (−28.12%) |
Sep 2, 2026 7w ago | 8-K | $40.75 | awaiting T+60 | — | $26.51 (−34.94%) |
Aug 13, 2026 10w ago | 8-K | $35.67 | awaiting T+60 | — | $26.51 (−25.68%) |
Aug 13, 2026 10w ago | Press Release | $35.67 | awaiting T+60 | — | $26.51 (−25.68%) |
Jul 22, 2026 13w ago | Insider Buy | $32.81 $22.75 | ▼ −30.66% | ▼ −34.31% | $26.51 (−19.20%) |
Jun 29, 2026 17w ago | Insider Cluster | $29.19 $33.31 | ▲ +14.11% | ▲ +10.50% | $26.51 (−9.18%) |
Jun 16, 2026 18w ago | Insider Cluster | $26.03 $36.16 | ▲ +38.92% | ▲ +36.23% | $26.51 (+1.84%) |
Jun 15, 2026 19w ago | Insider Cluster | $26.59 $36.88 | ▲ +38.70% | ▲ +36.84% | $26.51 (−0.30%) |
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