Disc Medicine (IRON) said Monday the US Food and Drug Administration agreed to "all attributes" of the company's study design for its Apollo trial to evaluate bitopertin inhibitor in erythropoietic protoporphyria, including a proposed primary endpoint of average monthly time in sunlight during the last month after a 6-month treatment.

The biopharmaceutical company said it intends to start the Apollo study by mid-2025, which will enroll participants ages 12 or more with erythropoietic protoporphyria and x-linked protoporphyria for six months with a 60 mg dose of bitopertin.

Disc Medicine said the regulator also agreed to additional measures including change in protoporphyrin IX, phototoxic reactions' occurrence, total pain-free time in sunlight, and patient global impression of change.

Shares of the company rose 22% in recent Monday trading.

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