Traders should monitor for upcoming data presentations and IND submission progress, which could catalyze re-rating in this micro-cap biotech. The partnership with a top-tier CDMO de-risks manufacturing and supports future U.S. trials.
Price Chart
Executive Summary
Tempest Therapeutics selected Cincinnati Children’s AGCTC as its contract development and manufacturing partner to advance TPST-2003, a dual-targeting CAR-T therapy for relapsed/refractory multiple myeloma, toward a potential IND filing in Q4 2026. This follows interim data showing 100% complete response in six evaluable patients in the REDEEM-1 trial, positioning the therapy as a potential best-in-class candidate.
Key Facts
- Tempest selected Cincinnati Children’s AGCTC as lead CDMO for TPST-2003 technology transfer and IND-enabling manufacturing.
- All six efficacy-evaluable patients in the REDEEM-1 trial achieved complete response (CR); overall response rate was 100% (25/25) across both REDEEM-1 and IIT studies.
- IND filing for TPST-2003 is targeted for Q4 2026, with tech transfer and development activities expected to conclude in Q3 2026.
- TPST-2003 is a dual-targeting CD19/BCMA CAR-T therapy for relapsed/refractory multiple myeloma, with potential to treat extramedullary disease and patients previously exposed to BCMA-targeted therapies.
- Tempest plans to present updated clinical data at a scientific meeting later in 2026.
Financial Impact
No direct financial impact disclosed; however, successful IND filing and clinical momentum could significantly increase valuation given Tempest's $12M market cap.
Risk Factors
- Tempest requires additional capital to fund development; going concern risk exists.
- Prior trial results may not predict future outcomes; safety or efficacy issues could emerge.
- IND approval is not guaranteed despite positive early data.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3253691 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | DEF 14A | $0.5102 | awaiting T+20 | — | $0.5100 (+0.04%) |
Oct 20, 2026 6d ago | DEFA14A | $0.5282 | awaiting T+20 | — | $0.5100 (−3.45%) |
Oct 20, 2026 6d ago | 8-K | $0.5282 | awaiting T+20 | — | $0.5100 (−3.45%) |
Oct 19, 2026 7d ago | 8-K | $0.5762 | awaiting T+20 | — | $0.5100 (−11.49%) |
Oct 2, 2026 25d ago | EFFECT | $0.8112 | awaiting T+20 | — | $0.5100 (+37.13%) |
Sep 25, 2026 4w ago | S-3 | $0.8316 $0.5102 | ▲ +38.65% | ▲ +38.62% | $0.5100 (+38.67%) |
Sep 17, 2026 5w ago | 8-K | $0.9680 $0.6240 | ▼ −35.54% | ▼ −35.74% | $0.5100 (−47.31%) |
Sep 16, 2026 5w ago | DEFA14A | $0.8950 $0.6350 | ▼ −29.05% | ▼ −30.51% | $0.5100 (−43.02%) |
Sep 16, 2026 5w ago | 8-K | $0.8950 $0.6350 | ▼ −29.05% | ▼ −30.51% | $0.5100 (−43.02%) |
Sep 11, 2026 6w ago | Press Release | $0.8117 $0.7601 | ▲ +6.36% | ▲ +8.23% | $0.5100 (+37.17%) |
US Market Status
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