Disc Medicine rallies 32% as investors await bitopertin trial results (IRON:NASDAQ)

Disc Medicine's (IRON) shares rose 60% after its Phase 3 APOLLO trial for bitopertin, a treatment for erythropoietic protoporphyria, met all primary and secondary endpoints. The trial showed significant improvements in symptoms, safety, and quality of life. The company plans to resubmit an NDA to the FDA by late 2026.

Disc Medicine (IRON) reported positive Phase 3 trial results for bitopertin, a drug developed with Roche (RHHBY), for a rare blood condition. IRON shares rose over 70% on the news.

Disc Medicine reported positive Phase 3 APOLLO trial results for bitopertin, meeting all primary and secondary endpoints. The drug showed a 41.4% reduction in PPIX and a 12.2-hour increase in pain-free light time. Disc plans to resubmit its NDA to the FDA by the end of 2026, with a decision expected by mid-2027. The company also reported improvements in quality-of-life measures and a generally well-tolerated safety profile.

Disc Medicine, Inc. (IRON) filed an SEC Form 8-K — Other Events. Exhibit 99.1 Disc Medicine Announces Success on All Primary and Secondary Endpoints in the Pivotal Phase 3 APOLLO Trial of Bitopertin in Adults and Adolescents with Erythropoietic Protoporphyria (EPP) • Positive APOLLO trial topline results demonstrated statistically significant

Disc Medicine (IRON) reported positive phase 3 trial results for bitopertin in treating erythropoietic protoporphyria. The trial met all primary and secondary endpoints, showing significant improvements in key measures. The company plans to resubmit an FDA application by late 2026. EPP is a rare disease with limited approved therapies.

Disc Medicine Inc (IRON) shares surged 32% premarket ahead of Phase 3 APOLLO trial results for bitopertin, a drug targeting erythropoietic protoporphyria. The trial is critical following an FDA Complete Response Letter earlier this year. The company has no revenue, a GF Score of 35/100, and significant insider selling.