secwatch.observer — SEC 8-K summary
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Issuer:     Tempest Therapeutics, Inc. (TPST)
CIK:        0001544227
Form:       8-K
Filed at:   2026-05-06T23:59:59+00:00
Accession:  0001193125-26-207601
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Tempest reports 100% CR rate in 15 CAR-T-naïve patients across two Phase 1 trials of TPST-2003
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- 100% complete response rate (CR) among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 in two Phase 1 trials.
- Favorable safety: no Grade >3 CRS or ICANS observed; 44 patients dosed across three studies to date.
- Median progression-free survival of 23.1 months in rrMM patients, including those with extramedullary disease.
- All 10 evaluable REDEEM-1 patients achieved CR per IMWG criteria; one prior BCMA CAR-T patient did not respond.
- Company plans to meet with FDA later this year to discuss initiating a U.S. registrational study.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1544227/000119312526207601/0001193125-26-207601-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1544227/000119312526207601/d93617d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-207601

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