Short answer
Disc Medicine, Inc. (IRON) filed an 8-K current report with the SEC on September 10, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Initial RESTORE-PV Phase 2 results for DISC-3405 in polycythemia vera.
Disc Medicine, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Initial RESTORE-PV Phase 2 results for DISC-3405 in polycythemia vera
- Press release issued September 9, 2026, with substantive trial data in Exhibit 99.1
- Clinical update potentially informs DISC-3405’s efficacy and development trajectory in PV
Item 8.01 · Other Events
- Phase 2 RESTORE-PV enrolled 40 adults; Cohort A dosing every 2 weeks, Cohort B every 4 weeks
- Cohort A mean hematocrit stayed below 45% through week 26, with initial symptom-burden improvement
- Mean phlebotomies fell from 4.0 to 0.6 over 26 weeks, supporting DISC-3405’s potential to reduce treatment burden
- 61.5% of Cohort A patients remained phlebotomy-free through 26 weeks; 77.8% during weeks 12–32
- Generally well-tolerated, with mild, self-limited injection-site reactions and adverse events consistent with PV
Item EX-99.1 · Exhibit EX-99.1
- RESTORE-PV Phase 2 data support DISC-3405’s mechanism, linking higher hepcidin and lower serum iron to hematocrit control
- Mean phlebotomies fell from 4.0 to 0.6 over 26 weeks among 13 Cohort A completers, with p<0.0001
- 61.5% remained phlebotomy-free through 26 weeks, supporting potential to reduce reliance on standard blood removal
- Mean hematocrit stayed below 45% through week 26, with initial symptom improvement and generally favorable tolerability
- Catalyst path includes additional RESTORE-PV data and sickle-cell Phase 1b results by end of 2026, plus FDA feedback on selcodebart pivotal development
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
Other Disc Medicine, Inc. 8-K filings
Get the next IRON 8-K as it lands
Follow IRON for push alerts, or ask the research agent what this filing means.