On July 30, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the second quarter ended June 30, 2026, and provided a review of recent program and corporate developments.
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"The anticipated readout of the Phase 3 APOLLO trial of bitopertin in EPP in Q4 marks a significant milestone. We have continued driving forward on this program over the past quarter with the launch of our EAP," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "We also look forward to significant advancement across the rest of our pipeline in the second half of 2026. We saw strong demand for the Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera, which is now fully enrolled with initial data coming ahead of schedule in Q3. Along with an expected end of Phase 2 FDA interaction on selcodebart in MF anemia in Q4, we will potentially be positioned to advance two more programs into pivotal-stage development in 2027."
Recent Highlights and Anticipated Milestones:
Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)
Completed Type A meeting with the FDA to discuss the CRL for bitopertin in erythropoietic protoporphyria (EPP) and aligned that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response and could potentially support a traditional approval
Presented updated data from the HELIOS open-label extension trial of bitopertin in EPP at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, demonstrating sustained reductions in protoporphyrin IX (PPIX), significant improvement in light tolerance measures, and favorable longer-term safety
Launched an Expanded Access Program (EAP) for bitopertin in the US and select other geographies, providing eligible patients with EPP and XLP access to treatment prior to a regulatory decision
On track to report APOLLO topline results in Q4 2026 and expect to submit CRL response and receive an FDA decision by mid-2027
APOLLO completed enrollment in March 2026 and enrolled ahead of schedule with a final N of 183
Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression)
Shared updated data from RALLY-MF trial of selcodebart in anemia of myelofibrosis (MF) in oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings, solidifying selcodebart’s differentiated emerging profile in MF. Data showed:
Major anemia response rate of 56% and overall anemia response rate of 72% across evaluable patients
Similar, strong response rates across transfusion cohorts and with or without background JAK inhibitor therapy
Additional data from RALLY-MF anticipated in Q4 2026, with an end-of-Phase 2 meeting with the FDA expected to occur by year-end
Received EU Orphan Drug Designation for selcodebart for the treatment of myelofibrosis
Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)
Completed enrollment for RESTORE-PV Phase 2 study in patients with polycythemia vera with initial data expected in Q3 2026
Progressing Phase 1b study in patients with sickle cell disease with initial data expected in Q4 2026
Second Quarter 2026 Financial Results:
Cash Position: Cash, cash equivalents, and marketable securities were $717.7 million as of June 30, 2026, which are expected to fund operational plans into 2029.
Research and Development Expenses: R&D expenses were $46.9 million for the three months ended June 30, 2026, as compared to $46.3 million for the three months ended June 30, 2025. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including the advancement of the selcodebart (DISC-0974) and DISC-3405 clinical studies and drug manufacturing, as well as increased headcount. These increases were partially offset by a decrease in manufacturing costs related to bitopertin and a $10.0 million milestone payment incurred upon initiation of the APOLLO study during the comparative period.
Selling, General and Administrative Expenses: SG&A expenses were $18.1 million for the three months ended June 30, 2026, as compared to $15.1 million for the three months ended June 30, 2025. The increase in SG&A expenses was primarily due to increased headcount.
Net Loss: Net loss was $59.5 million for the three months ended June 30, 2026, as compared to $55.2 million for the three months ended June 30, 2025. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.
(Press release, Disc Medicine, JUL 30, 2026, View Source [SID1234669560])