Disc Medicine’s Rare Disease Drug Succeeds in Late-Stage Trial

Disc Medicine's rare disease drug succeeds in late-stage trial

Disc’s once-spurned rare disease drug to get a second chance at approval

Months after the FDA rejected its treatment for a rare light-sensitivity disease, the biotech claimed success in a Phase 3 trial and now plans to re-engage regulators.

Disc Medicine reports bitopertin Phase 3 success in EPP

Disc Medicine reports both primary endpoints met in its 183-patient APOLLO trial and plans an FDA resubmission by the end of 2026.

Disc Medicine Stock Soars 31% After Bitopertin Hits All Goals in Pivotal Trial for Rare Sunlight Disorder

Disc Medicine shares rose sharply after the company reported positive Phase 3 results for bitopertin in erythropoietic protoporphyria, while seeking a renewed FDA review.

Disc Medicine's Bitopertin Meets Both Primary Goals in Phase 3 Trial

The 183-patient trial tested the drug in two rare blood disorders. Disc Medicine plans to resubmit its FDA application by the end of 2026.

After FDA rejection, Disc Medicine's 'sun allergy' drug hits home run in Phase 3

Disc Medicine’s treatment for a rare disease that makes sun exposure painful succeeded on all endpoints in a Phase 3 study. The result sets the company on a path to redemption after the FDA unexpectedly ...