Disc Medicine EPP Treatment Fails to Get FDA Accelerated Approval
By Nicholas G. Miller
Disc Medicine received a complete response letter from the Food and Drug Administration denying it accelerated approval of its bitopertin treatment for erythropoietic protoporphyria, a metabolic disorder causing photosensitivity.
The FDA said results of the company's ongoing Phase 3 study could serve as evidence to support traditional approval. Topline data from the study is expected in the fourth quarter.
Following the trial, Disc would then file a response to the complete response letter and expect an updated FDA ruling by mid-2027.
"We are committed to delivering bitopertin to patients, knowing how critical this potentially disease-modifying therapy is to the EPP community. While our efforts at utilizing expedited pathways to get bitopertin to patients quickly have not come to fruition, we are continuing to pursue all avenues in support of FDA approval," said Chief Executive John Quisel.
Shares fell 29% to $51.19.
Write to Nicholas G. Miller at nicholas.miller@wsj.com
(END) Dow Jones Newswires
February 13, 2026 16:29 ET (21:29 GMT)
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