The accelerated timeline for the futility analysis and database lock is the key catalyst catalyst; the next major binary events are the pre-specified futility analysis (expected early next year, and the database lock around end of end of next year. The outcome of the trial is binary and high-impact for a pre-revenue biotech.
Price Chart
Executive Summary
Biodexa announced enrollment of the 100th patient in its registrational Phase 3 trial (Serenta) of eRapa for Familial Adenomatous Polyposis (FAP). The CEO indicated that based on current PFS event accrual, the pre-specified futility analysis could occur early next year and database lock around the end of next year, both significantly sooner than originally anticipated. This is an operational milestone for a clinical-stage biotech with no approved FAP therapy, but no efficacy data or financial results were disclosed.
Key Facts
- 100 patients enrolled in registrational Phase 3 trial (Serenta) of eRapa for FAP
- Trial recruiting at 29 clinical sites across US and five European countries; two more Canadian sites expected shortly
- Pre-specified futility analysis after 25 PFS events; database lock after 75 PFS events
- CEO states futility analysis could occur early next year and database lock around end of next year, both sooner than originally anticipated
- Phase 3 program supported by a $20 million grant from CPRIT
- No approved therapeutic option currently exists for FAP; eRapa has Orphan Drug Designation in US and Europe
Financial Impact
No financial figures reported; Phase 3 program supported by $20 million CPRIT grant
Risk Factors
- Futility analysis outcome is binary and could stop the trial early
- No efficacy data disclosed; earlier interim results may not predict final results
- Clinical-stage biotech with no approved products and need for additional capital
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001171843-26-006616 |
| Document: f6k_101426.htm | 0001171843-26-006616 |
| Document: 0001171843-26-006616-index-headers.html | 0001171843-26-006616 |
| Document: 0001171843-26-006616-index.html | 0001171843-26-006616 |
| Document: 0001171843-26-006616.txt | 0001171843-26-006616 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 14, 2026 12d ago | 6-K | $0.4849 | awaiting T+20 | — | — |
Oct 8, 2026 18d ago | 6-K | $0.4602 | awaiting T+20 | — | — |
Oct 1, 2026 25d ago | EFFECT | $0.6326 | awaiting T+20 | — | — |
Sep 24, 2026 4w ago | F-1 | $0.6750 $0.4140 | ▲ +38.67% | ▲ +38.25% | — |
Sep 15, 2026 5w ago | 6-K | $1.33 $0.3502 | ▼ −73.67% | ▼ −76.65% | — |
Sep 11, 2026 6w ago | 6-K | $1.12 $0.3832 | ▲ +65.79% | ▲ +68.05% | — |
Aug 4, 2026 11w ago | EFFECT | $1.49 $0.7808 | ▲ +47.60% | ▲ +46.36% | — |
Jun 30, 2026 16w ago | 6-K | $3.00 $1.45 | ▼ −51.83% | ▼ −49.65% | — |
Jun 30, 2026 16w ago | 6-K | $2.91 $1.45 | ▲ +50.34% | ▲ +48.03% | — |
Jun 17, 2026 18w ago | 6-K | $3.06 $2.13 | ▼ −30.39% | ▼ −30.93% | — |
US Market Status
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