09:21 AM EDT, 09/30/2025 (MT Newswires) -- Disc Medicine ( IRON ) said Tuesday it has submitted a new drug application with the US Food and Drug Administration for bitopertin to treat patients 12 years and older with erythropoietic protoporphyria, including X-linked protoporphyria.

The biopharmaceutical company filed the NDA under the FDA's Accelerated Approval Program and requested a priority review, it said.

Disc Medicine ( IRON ) describes erythropoietic protoporphyria as a "rare, debilitating and potentially life-threatening disease," which it said is caused by mutations that result in the accumulation of a toxic, photoactive intermediate called protoporphyrin IX.

Shares of the company were up 1.4% in recent premarket activity.