---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-123853"
form_type: "8-K"
ticker: "RIGL"
cik: "0001034842"
company_name: "RIGEL PHARMACEUTICALS INC"
filed_at: "2022-12-02T23:59:59+00:00"
generated_at: "2026-06-21T10:02:28.939774+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Rigel's REZLIDHIA for mIDH1 relapsed/refractory AML

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-22-123853
- form_type: 8-K
- ticker: RIGL
- cik: 0001034842
- company_name: RIGEL PHARMACEUTICALS INC
- filed_at: 2022-12-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1034842/000110465922123853/0001104659-22-123853-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1034842/000110465922123853/tm2231791d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-123853
- JSON: https://secwatch.observer/filing/0001104659-22-123853.json
- Plain text: https://secwatch.observer/filing/0001104659-22-123853.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.