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AI brief of an SEC Form 8-K · Disc Medicine, Inc. (IRON)

Disc Medicine says Phase 3 APOLLO trial of bitopertin met all endpoints in EPP

Positive Impact 4 of 5 other Written later

Disc Medicine reported topline results from the pivotal Phase 3 APOLLO trial of bitopertin in erythropoietic protoporphyria (EPP), saying the trial met all primary and secondary endpoints. The company plans to resubmit a New Drug Application to the FDA by the end of 2026, with an FDA decision anticipated by mid-2027, so the results bear directly on the timing of a possible approval for its lead program.

Key points

  • Both co-primary endpoints were statistically significant: whole-blood PPIX fell 41.4% vs. placebo (p<0.0001), and time in light without pain rose 12.2 hours vs. placebo (p=0.0010)
  • Phototoxic reactions fell in incidence (p<0.0001 vs. placebo), and dizziness was the most common adverse event in the bitopertin group at 50%
  • The trial enrolled 183 patients, and the company plans an NDA resubmission by end of 2026 with an FDA decision anticipated by mid-2027

The filing

CompanyDisc Medicine, Inc. (IRON)
Form8-K, current report
Filed with the SECOct 19, 2026, 7:08 AM ET
Accession number0001193125-26-424649

Items reported: 7.01 Regulation FD Disclosure8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 19, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.