Disc Medicine, Inc. 8-K

What Happened Disc Medicine, Inc. (IRON) filed an 8-K reporting it will host a previously announced conference call on February 17, 2026 at 8:00 AM ET to discuss the U.S. Food and Drug Administration’s Complete Response Letter (CRL) issued on February 13, 2026 for the company’s New Drug Application (NDA) for bitopertin, intended to treat erythropoietic protoporphyria (EPP). The company attached the slide presentation for the call as Exhibit 99.1 to the filing and will make an archived webcast available after the call.

Key Details

• Conference call date/time: February 17, 2026 at 8:00 AM ET.
• FDA action: Complete Response Letter issued February 13, 2026 for the bitopertin NDA (EPP indication).
• Investor access: Archived webcast available for 30 days on Disc Medicine’s Events & Presentations webpage.
• Filing: Slide presentation attached as Exhibit 99.1 to the Form 8-K signed by CEO John Quisel on February 17, 2026.

Why It Matters An FDA Complete Response Letter means the agency did not approve the NDA as submitted and has issued comments or requests that must be addressed before approval. The company’s conference call and slides will provide management’s explanation of the CRL and planned next steps, which are material to the approval timeline and could affect the company’s outlook and valuation. Investors should review the webcast/slides for details on the regulatory issues and any timelines or remediation plans disclosed by management.