Business Context and Reporting Period
Company: Disc Medicine, Inc. (Nasdaq: IRON)
Filing Type: Form 8-K (Current Report)
Date of Report: September 09, 2026
Subject: Announcement of initial results from the RESTORE-PV Phase 2 clinical trial for DISC-3405 in patients with polycythemia vera (PV).
Key Financial Metrics
This filing is a current report regarding clinical trial results and does not contain financial statements. The text does not provide values for revenue, profit, cash flow, margins, debt, or liquidity.
Material Changes and Clinical Results
The filing details the initial results of the RESTORE-PV Phase 2, multi-center, open-label trial involving 40 adult participants (20 in Cohort A, 20 in Cohort B). Key findings include:
- Pharmacokinetics (Cohort A): Demonstrated dose-proportional PK, elevation of hepcidin, reduction of serum iron, and increase in ferritin.
- Hematocrit Control (Cohort A): Mean hematocrit was maintained stably below 45% through week 26, leading to initial improvement in symptom burden.
- Phlebotomy Reduction (Cohort A):
- Mean total phlebotomy events significantly decreased from 4.0 (baseline) to 0.6 (post-Day 1) over 26 weeks (p<0.0001) for 13 patients completing the study.
- 61.5% of participants remained entirely phlebotomy-free post-baseline through 26 weeks.
- 77.8% of participants (n=9) remained phlebotomy-free during the first maintenance period (weeks 12-32).
- Safety (Cohorts A and B): DISC-3405 was generally well-tolerated. Adverse events were consistent with the underlying disease, with a low rate of mild, self-limited injection site reactions.
Guidance, Outlook, and Risks
Management Commentary: The Company announced these results via a press release attached as Exhibit 99.1. The data suggests DISC-3405 effectively controls hematocrit and reduces the need for phlebotomy in PV patients.
Forward-Looking Statements: The filing explicitly states that the Company undertakes no obligation to update, supplement, or amend the material attached as Exhibit 99.1. The information is furnished and not deemed "filed" for purposes of Section 18 of the Exchange Act.
Risks: No specific new risks were detailed in this text beyond the standard clinical trial context. The safety profile noted adverse events consistent with the underlying disease.
Investor Verification Checklist
- Verify the full text of the press release (Exhibit 99.1) for detailed statistical tables and specific adverse event listings.
- Confirm the enrollment status and data cut-off dates for Cohort B, as only baseline and safety data were announced for this cohort.
- Review the Company's most recent 10-Q or 10-K for current cash runway and burn rate, as this 8-K contains no financial data.
- Monitor upcoming regulatory interactions or presentations regarding the path to Phase 3 or NDA filing based on these Phase 2 results.