Disc Medicine soars as rare disease drug aces key trial
IRON•
IRON•Disc Medicine said bitopertin met all main and secondary goals in a late-stage study for erythropoietic protoporphyria. Shares rose 65.20% to $93.90 premarket as the company said it plans to resubmit the drug for U.S. approval by the end of 2026.
Disc Medicine said its experimental drug bitopertin met all main and secondary goals in a late-stage study for erythropoietic protoporphyria, a blood disorder that makes patients extremely sensitive to sunlight. The drug reduces levels of a harmful substance linked to the disease and helps patients spend more time in sunlight without pain.
The U.S. FDA declined to approve bitopertin earlier this year, saying previous studies did not clearly link biomarker improvements to clinical benefit. Disc Medicine plans to resubmit the drug for U.S. approval by the end of 2026 and expects an FDA decision by mid-2027.