Business Context and Reporting Period
Company: Disc Medicine, Inc.
Filing Type: Form 8-K (Current Report)
Date of Report: February 17, 2026
Principal Executive Offices: Watertown, Massachusetts
Trading Symbol: IRON (Nasdaq Global Market)
This filing serves as a Regulation FD disclosure regarding a previously announced conference call scheduled for February 17, 2026, at 8:00 AM ET.
Key Financial Metrics
The filing text does not provide a clear value for revenue, profit, cash flow, margins, debt, or liquidity. This document is a current report regarding a regulatory event and does not contain financial statements or performance metrics.
Material Changes
No material financial changes are reported in this filing. The primary event is the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on February 13, 2026.
Guidance, Outlook, and Management Commentary
- Regulatory Event: The FDA issued a Complete Response Letter regarding the Company's New Drug Application (NDA) for bitopertin.
- Indication: The application was for the treatment of patients with erythropoietic protoporphyria.
- Management Action: The Company will host a conference call to discuss the CRL. A slide presentation is attached as Exhibit 99.1.
- Forward-Looking Statements: The Company explicitly states it undertakes no obligation to update, supplement, or amend the material attached as Exhibit 99.1.
Investor Verification Checklist
- Review the attached Exhibit 99.1 (presentation dated February 2026) for specific details regarding the FDA's Complete Response Letter.
- Listen to the archived webcast of the February 17, 2026 conference call for management's interpretation of the CRL and potential next steps.
- Verify the status of the bitopertin development program and any revised timelines for regulatory resubmission.
- Check subsequent filings for any updates on the Company's cash position, as the CRL may impact future capital requirements.