secwatch.observer — SEC 8-K summary
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Issuer:     Disc Medicine, Inc. (IRON)
CIK:        0001816736
Form:       8-K
Filed at:   2025-10-20T23:59:59+00:00
Accession:  0001193125-25-242959
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Disc Medicine reports $615.9M cash; bitopertin NDA submitted for accelerated review (CNPV)
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- Preliminary unaudited cash, equivalents and marketable securities of ~$615.9M as of September 30, 2025.
- NDA for bitopertin in EPP submitted Sept 29, 2025; awarded FDA CNPV for 1-2 month review; potential US approval late 2025/early 2026.
- Phase 2 RALLY-MF trial of DISC-0974 in anemia of MF: initial data by year-end 2025, topline data in 2026.
- DISC-3405 Phase 2 PV topline data expected 2026; Phase 1b in sickle cell disease by year-end 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1816736/000119312525242959/0001193125-25-242959-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1816736/000119312525242959/d272031d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-242959

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