This is a transformative catalyst for SNTI — FDA alignment on a registrational trial and identification of a donor phenotype that triples cCR rates materially de-risks the program. Expect significant upside as the market prices in a higher probability of approval. Monitor for initiation of the pivotal trial and any partnership interest.
Price Chart
Executive Summary
Senti Bio announced a successful Type B RMAT meeting with the FDA, finalizing a single-arm registrational trial strategy for SENTI-202 in R/R AML. Updated Phase 1 data show a 50% composite CR rate (7/14) in patients receiving Donor X-derived NK cells vs 12.5% (1/8) without, with durable MRD-negative remissions up to 21+ months. The company will use Donor X material for all future manufacturing, de-risking the pivotal study and supporting a potential registration path.
Key Facts
- FDA Type B RMAT meeting completed; single-arm pivotal trial strategy finalized for SENTI-202.
- Phase 1 data: 50% cCR (7/14) with Donor X-derived NK cells vs 12.5% (1/8) without.
- 100% of complete remissions are MRD-negative; longest remission 21+ months.
- Donor X phenotype found in ~50% of adult donors, independent of HLA/KIR matching.
- All future SENTI-202 manufacturing will use Donor X material, including for pivotal study.
- At RP2D, ORR 44% and cCR 37.5% across all patients; all CRs MRD-negative.
- SENTI-202 has RMAT and Orphan Drug Designation from FDA.
Financial Impact
Early-stage biotech with $30M market cap; positive regulatory milestone and improved efficacy data could drive significant re-rating. No financial figures disclosed.
Risk Factors
- Single-arm pivotal trial design carries regulatory risk; FDA may still require randomized data.
- Donor X phenotype is present in only ~50% of donors, potentially limiting manufacturing scalability.
- Early-stage biotech with limited cash runway; may need to raise capital to fund pivotal study.
- Competing therapies in R/R AML (e.g., gilteritinib, venetoclax combinations) may limit market share.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3294958 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 8-K | — | awaiting T+5 | — | — |
Oct 13, 2026 13d ago | DEFA14A | $0.2408 $0.2175 | ▼ −9.68% | ▼ −10.13% | $0.1751 (−27.28%) |
Oct 13, 2026 13d ago | 8-K | $0.2408 $0.2175 | ▲ +9.68% | ▲ +10.13% | $0.1751 (+27.28%) |
Sep 25, 2026 4w ago | EFFECT | $0.3293 $0.3223 | ▲ +2.13% | ▲ +1.90% | $0.1751 (+46.83%) |
Sep 24, 2026 4w ago | DEFM14A | $0.3293 $0.3223 | ▲ +2.13% | ▲ +1.90% | $0.1751 (+46.83%) |
Sep 22, 2026 4w ago | S-3/A | $0.3156 $0.3075 | ▲ +2.57% | ▲ +1.38% | $0.1751 (+44.52%) |
Sep 10, 2026 6w ago | S-3/A | $0.3060 $0.3200 | ▼ −4.58% | ▼ −4.80% | $0.1751 (+42.78%) |
Sep 4, 2026 7w ago | DEFA14A | $0.3326 $0.3021 | ▼ −9.17% | ▼ −7.96% | $0.1751 (−47.35%) |
Sep 4, 2026 7w ago | 8-K | $0.3326 $0.3021 | ▲ +9.17% | ▲ +7.96% | $0.1751 (+47.35%) |
Aug 20, 2026 9w ago | 8-K | $0.3886 $0.3770 | ▲ +2.99% | ▲ +3.46% | $0.1751 (+54.94%) |
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