Disc Medicine (IRON) reported Tuesday "positive" feedback from its Type C meeting with the US Food and Drug Administration over its post-marketing confirmatory trial for bitopertin in erythropoietic protoporphyria.

The company said the meeting resulted in alignment on the design of the Apollo post-marketing confirmatory trial.

Disc said it plans to initiate the trial by mid-2025 and will include sites in the US, Canada, Europe, and Australia.

Based on guidance toward a new drug application submission in H2 2025, Disc said it expects enrollment of the trial to be well underway by the time of an accelerated approval, if granted.

Shares of Disc Medicine were up over 3% in recent trading.

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