Monitor upcoming presentation of complete REDEEM-1 results and FDA discussions regarding the registrational trial design. Positive data could drive valuation higher ahead of pivotal study initiation.
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Executive Summary
Tempest Therapeutics announced positive interim clinical data from its REDEEM-1 trial for TPST-2003, a dual-targeting CAR-T therapy for relapsed/refractory multiple myeloma. All six efficacy-evaluable patients achieved a complete response with a favorable safety profile, supporting plans to initiate a U.S. registrational study in 2026.
Key Facts
- 100% complete response rate in all six efficacy-evaluable patients in the REDEEM-1 trial
- Favorable safety profile with no Grade >3 CRS or ICANS observed
- Prior investigator-initiated trial showed median progression-free survival of 23.1 months
- 36 patients with relapsed/refractory multiple myeloma treated across two studies
- Company plans to submit a U.S. IND and initiate a U.S. registrational study in 2026
- TPST-2003 uses a proprietary parallel dual-targeting CAR architecture targeting CD19/BCMA
Financial Impact
No direct financial figures disclosed, but successful registrational trial could position TPST-2003 as a class-leading therapy with significant commercial potential in multiple myeloma
Risk Factors
- Clinical results from small patient cohort may not be replicated in larger trials
- Regulatory delays or requirements for additional studies before registrational trial approval
- Competition from other CAR-T therapies and emerging treatments in multiple myeloma
- Need for additional capital to fund planned U.S. registrational trial
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-068614 |
| Document: d22967d8k.htm | 0001193125-26-068614 |
| Document: 0001193125-26-068614-index-headers.html | 0001193125-26-068614 |
| Document: 0001193125-26-068614-index.html | 0001193125-26-068614 |
| Document: 0001193125-26-068614.txt | 0001193125-26-068614 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | DEF 14A | — | awaiting T+20 | — | — |
Oct 20, 2026 6d ago | DEFA14A | $0.5282 | awaiting T+20 | — | $0.5102 (−3.41%) |
Oct 20, 2026 6d ago | 8-K | $0.5282 | awaiting T+20 | — | $0.5102 (−3.41%) |
Oct 19, 2026 7d ago | 8-K | $0.5762 | awaiting T+20 | — | $0.5102 (−11.45%) |
Oct 2, 2026 24d ago | EFFECT | $0.8112 | awaiting T+20 | — | $0.5102 (+37.11%) |
Sep 25, 2026 4w ago | S-3 | $0.8316 $0.5102 | ▲ +38.65% | ▲ +38.62% | $0.5102 (+38.65%) |
Sep 17, 2026 5w ago | 8-K | $0.9680 $0.6240 | ▼ −35.54% | ▼ −35.74% | $0.5102 (−47.29%) |
Sep 16, 2026 5w ago | DEFA14A | $0.8950 $0.6350 | ▼ −29.05% | ▼ −30.51% | $0.5102 (−42.99%) |
Sep 16, 2026 5w ago | 8-K | $0.8950 $0.6350 | ▼ −29.05% | ▼ −30.51% | $0.5102 (−42.99%) |
Sep 11, 2026 6w ago | Press Release | $0.8117 $0.7601 | ▲ +6.36% | ▲ +8.23% | $0.5102 (+37.14%) |
US Market Status
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