secwatch.observer — SEC 8-K summary
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Issuer:     RIGEL PHARMACEUTICALS INC (RIGL)
CIK:        0001034842
Form:       8-K
Filed at:   2022-12-02T23:59:59+00:00
Accession:  0001104659-22-123853
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves Rigel's REZLIDHIA for mIDH1 relapsed/refractory AML
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- FDA approved REZLIDHIA (olutasidenib) for adult patients with relapsed/refractory AML with IDH1 mutation.
- Phase 2 trial showed 35% CR+CRh rate (51/147) with median duration of response 25.9 months.
- Median time to CR or CRh was 1.9 months; 92% of responders achieved CR.
- Rigel acquired exclusive worldwide license from Forma Therapeutics in August 2022.
- Conference call and webcast today at 6:30 p.m. ET to discuss approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1034842/000110465922123853/0001104659-22-123853-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1034842/000110465922123853/tm2231791d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-123853

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer