Disc Medicine reported Phase 3 success for its AMPA receptor modulator bitopertin (APOLLO study) in erythropoietic protoporphyria (EPP), addressing FDA concerns that had driven skepticism around biomarker interpretations. The company said the drug met both co-primary endpoints compared with placebo. According to the update, bitopertin reduced whole-blood protoporphyrin IX (PPIX) intermediate levels by 41.4% (p<0.0001) and increased average monthly time in light without pain by 12.2 hours (p=0.001) during month six. The result was accompanied by market reaction described as sending the biotech’s shares up nearly 40%. The report positions the data as a pivot from earlier efficacy uncertainty toward registrational momentum, following other mixed Phase 3 developments mentioned alongside the update.