Disc Medicine (IRON) announced the submission of a New Drug Application to the FDA for bitopertin for patients aged 12 years and older with erythropoietic protoporphyria, including X-linked protoporphyria. Disc submitted the NDA under the FDA's accelerated approval pathway using reduction of protoporphyrin IX as a surrogate endpoint and requested a Priority Review.
The company said the NDA submission is supported by the results of the Phase 2 BEACON and AURORA studies in EPP, as well as prior data generated by Roche, including a safety database of over 4,000 clinical trial participants.
Disc obtained global rights to bitopertin under a license agreement from Roche in May 2021.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.