The Tip Desk

Disc Medicine Widens Loss as Key Trial Readout Nears

The company ended June with $717.7 million in cash and investments, providing runway into 2029.

Disc Medicine (IRON), a clinical-stage biopharmaceutical company developing treatments for serious hematologic diseases, widened its second-quarter net loss as it advanced its clinical portfolio toward several regulatory milestones.

The quarter centered on bitopertin after Disc completed a Type A meeting with the Food and Drug Administration. The Phase 3 APOLLO study, if successful, can underpin its response to the drug's complete response letter and potentially support traditional approval. Topline data remain expected in the fourth quarter of 2026, with an FDA decision targeted by mid-2027.

The net loss widened to $59.5 million from $55.2 million a year earlier. The loss narrowed to $1.54 a share from $1.58 as weighted-average shares increased to 38.7 million from 35.0 million.

Total operating expenses rose to $65.1 million from $61.4 million, widening the operating loss by the same amount. Research-and-development expense edged up to $46.9 million from $46.3 million as the portfolio progressed, while selling, general and administrative expense increased to $18.1 million from $15.1 million.

The spending increase was sharper over the first half. Operating expenses climbed to $134.6 million from $101.4 million, including $92.8 million in research and development and $41.8 million in selling, general and administrative costs. The six-month net loss widened to $123.0 million from $89.3 million.

Disc also launched an expanded-access program for bitopertin in eligible erythropoietic protoporphyria and X-linked protoporphyria patients in the U.S. and selected other geographies. The company completed enrollment in the RESTORE-PV Phase 2 trial and moved the initial DISC-3405 polycythemia-vera data release ahead to the third quarter of 2026.

Updated RALLY-MF results showed selcodebart produced a 56% major anemia response rate and a 72% overall anemia response rate among evaluable patients. Responses were similar across transfusion cohorts and regardless of background JAK-inhibitor therapy.

Cash, cash equivalents and marketable securities declined from $791.2 million at the end of 2025 to $717.7 million on June 30. Those funds provide runway into 2029, extending beyond the expected APOLLO readout and targeted regulatory decision.