8-K - Disc Medicine, Inc. | StockGist

AI Analysis

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Disc Medicine, Inc. received a Complete Response Letter from the FDA on February 13, 2026, for its NDA for bitopertin in erythropoietic protoporphyria, citing insufficient evidence linking PPIX biomarker to clinical endpoints and requiring APOLLO Phase 3 study results. The company plans to complete APOLLO enrollment by March 2026 with topline data in Q4 2026 to support CRL response.

Key Takeaways

1FDA issued CRL on February 13, 2026, for bitopertin NDA due to PPIX surrogate biomarker concerns

2FDA requires APOLLO Phase 3 results before approval decision

3APOLLO trial closing enrollment in March 2026; topline data expected Q4 2026

4APOLLO: ~150 patients, 1:1 randomized, double-blind, placebo-controlled, 60 mg dose, 6-month treatment

5Co-primary endpoints: average monthly time in sunlight without pain (month 6), percent change in whole blood metal-free PPIX (6 months)

6Plans Type A meeting with FDA and CRL response submission in late 2026; potential decision mid-2027

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

of this Current Report on Form 8-K, including Exhibit 99.1, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securi

Regulation Fd

9.01

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Disc Medicine, Inc. presentation, dated February 2026 104 Cover Page Interactive Da

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1