secwatch.observer — SEC 8-K summary
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Issuer:     Disc Medicine, Inc. (IRON)
CIK:        0001816736
Form:       8-K
Filed at:   2026-07-30T12:32:49+00:00
Accession:  0001193125-26-325031
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Disc Medicine aligns with FDA on bitopertin CRL path; APOLLO topline due Q4 2026
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- FDA Type A meeting aligned that successful Phase 3 APOLLO can serve as basis for CRL response; topline data expected Q4 2026.
- Cash, cash equivalents, and marketable securities of $717.7M as of June 30, 2026; net loss of $59.5M in Q2 2026 vs $55.2M in Q2 2025.
- RESTORE-PV Phase 2 of DISC-3405 fully enrolled; initial data now expected in Q3 2026.
- Selcodebart RALLY-MF data showed 56% major anemia response rate; end-of-Phase 2 FDA meeting expected by year-end.
- Expanded Access Program launched for bitopertin in EPP in the US and select geographies.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1816736/000119312526325031/0001193125-26-325031-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1816736/000119312526325031/iron-20260730.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-325031

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