secwatch.observer — SEC 8-K summary
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Issuer:     Disc Medicine, Inc. (IRON)
CIK:        0001816736
Form:       8-K
Filed at:   2026-10-19T11:08:08+00:00
Accession:  0001193125-26-424649
Event type: other_material
Sentiment:  positive
Materiality: 0.92
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Disc Medicine's bitopertin meets all Phase 3 APOLLO endpoints in EPP; NDA resubmission planned for end-2026
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- Phase 3 APOLLO enrolled 183 EPP/XLP patients aged 12+ across US, Canada, Europe, Australia; randomized 1:1 to 60 mg oral bitopertin or placebo for 6 months.
- Co-primary endpoints met: whole-blood metal-free PPIX fell 41.4% vs placebo (p<0.0001); average monthly pain-free light time rose 12.2 hours in month 6 (p=0.0010).
- All secondary endpoints significant: lower phototoxic reaction incidence (p<0.0001), more cumulative pain-free light time (p<0.0001), improved PGIC and PGIS scores (p<0.0001).
- Dizziness was most common TEAE at 50%, mild/moderate and generally transient; no TEAEs above Grade 3 and no new safety signals.
- Disc plans NDA resubmission to FDA by end-2026, with FDA decision anticipated by mid-2027; webcast Oct 19, 2026 at 8:00am ET.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1816736/000119312526424649/0001193125-26-424649-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1816736/000119312526424649/d156263d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-424649

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