Disc Medicine Aktie
WKN DE: A3D063 / ISIN: US2546041011
30.09.2025 16:05:05
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Disc Medicine Announces Submission Of NDA For Bitopertin
(RTTNews) - 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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