secwatch.observer — SEC 8-K summary
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Issuer:     Disc Medicine, Inc. (IRON)
CIK:        0001816736
Form:       8-K
Filed at:   2025-01-21T23:59:59+00:00
Accession:  0001193125-25-009095
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Disc Medicine aligns with FDA on bitopertin confirmatory trial design; NDA planned H2 2025
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- Achieved FDA alignment on APOLLO post-marketing trial design for bitopertin in EPP and XLP.
- Co-primary endpoints: monthly total sunlight time without pain and percent change in whole-blood PPIX.
- Plans to submit NDA for accelerated approval in H2 2025 based on Phase 2 BEACON and AURORA data.
- APOLLO trial to enroll ~150 patients aged 12+, randomized 1:1, 60 mg dose, double-blind placebo-controlled.
- Trial initiation expected by mid-2025; enrollment underway by potential accelerated approval date.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1816736/000119312525009095/0001193125-25-009095-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1816736/000119312525009095/d858127d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-009095

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