8-K - Disc Medicine, Inc. | StockGist

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Disc Medicine, Inc. received a Complete Response Letter from the FDA for its New Drug Application for bitopertin as a treatment for erythropoietic protoporphyria, delaying potential approval. The FDA indicated the ongoing Phase 3 APOLLO study results could support traditional approval, with topline data anticipated in Q4 2026.

Key Takeaways

1FDA issued a Complete Response Letter for the NDA for bitopertin as a treatment for EPP on February 13, 2026.

2FDA acknowledged AURORA and BEACON trials provided sufficient evidence that bitopertin significantly lowers PPIX.

3FDA concluded trials did not show evidence of association between percent change in PPIX and sunlight exposure-based endpoints.

4FDA indicated results of the ongoing Phase 3 APOLLO study could serve as evidence to support traditional approval.

5Topline data from the APOLLO study is anticipated in Q4 2026.

6Disc plans to request a Type A meeting with the FDA to review its approach.

Current Report Details

Event Type

Regulation Fd

Other Event

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

of this Current Report on Form 8‑K and Exhibit 99.1 and Exhibit 99.2 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Ex

Regulation Fd

8.01

Other Events. On February 13, 2026, the Company received a CRL from the FDA for the Company’s NDA for bitopertin as a treatment for patients with EPP. Item 9.01

Other Event

Exhibits (3)

8-K

99.1

EX-99.1

99.2

EX-99.2