Disc Medicine's bitopertin meets all Phase 3 APOLLO endpoints in EPP; NDA resubmission planned for end-2026

Disc Medicine, Inc.

• 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.