Disc Medicine surges 38% after bitopertin clears Phase 3 trial endpoints

Disc Medicine (NASDAQ:IRON) reported that its drug bitopertin met Phase III trial endpoints, showing significant improvements in patient-reported quality-of-life measures. No treatment-related serious adverse events occurred, and the company plans to resubmit the drug to the FDA. Disc Medicine estimates 20,000 people in the U.S. may have the target condition, erythropoietic protoporphyria (EPP). The company also has other drug candidates in development for hematologic diseases.

BMO Capital raised its price target for Disc Medicine (IRON) to $120 from $100, citing positive Phase 3 trial results. The firm expects FDA approval in 2027 and increased its sales forecast for bitopertin. IRON trades at $79.73, with analyst targets ranging from $83 to $128. The company reported promising Phase 2 trial results for DISC-3405, leading to reiterated Buy ratings from other analysts.

Disc Medicine's shares rose 35% after its Phase 3 trial of bitopertin met all primary and secondary endpoints. The drug reduced PPIX levels by 41.4% and increased pain-free sunlight exposure. The FDA had previously rejected the drug, but these results address its concerns. Disc plans to resubmit for FDA approval by late 2026 and has $718 million in cash, expected to last into 2029. The company reported $35 million in projected 2027 revenue and $144 million for 2028.

Disc Medicine (IRON) reported positive Phase 3 trial results for bitopertin in treating erythropoietic protoporphyria (EPP), meeting all primary and secondary endpoints. The company plans to resubmit its NDA to the FDA by the end of 2026. Bitopertin showed a 41.4% reduction in PPIX levels and increased time in light without pain. The stock surged 45.19% in pre-market trading.

Disc Medicine (IRON) shares rose 60% after its Phase 3 APOLLO trial for bitopertin met primary and secondary endpoints. The trial showed a 41.4% reduction in protoporphyrin levels and increased pain-free light exposure. The company plans to resubmit an NDA by late 2026, with a potential FDA decision in mid-2027. Bitopertin was generally well-tolerated, with dizziness being the most common side effect.

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.