Disc Medicine对FDA对比开汀的完整回应信表示不满

2026-02-14 05:59

Disc Medicine (IRON) closed down ~22% Friday after receiving a Complete Response Letter from the US FDA for its application for bitopertin as a treatment for erythropoietic protoporphyria.
The agency noted it will need to see the results of the phase 3 APOLLO trial before making a final decision. Topline data is expected in Q4.
Disc's NDA included data from the phase 2 AURORA and BEACON trials. The company noted that the FDA found the results from these trials indicated bitopertin led to significantly lowered levels of PPIX, the molecule in the skin that causes the condition.
Bitopertin received accelerated approval review and is one of the candidates under the FDA Commissioner’s National Priority Voucher pilot program.
Erythropoietic protoporphyria is a rare, inherited condition characterized by severe skin photosensitivity.

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