Disc Medicine's DISC-3405 Cuts Phlebotomy Need 85% in Phase 2 PV Trial
IRON sits 95% above its 52-week low of $40.
Summary
Disc Medicine unveiled positive initial Phase 2 data for DISC-3405 in polycythemia vera, showing an 85% reduction in phlebotomy events and controlled hematocrit. The company now has two programs advancing toward pivotal development in myeloproliferative neoplasms.
Key Events · Product Development and Regulatory · IRON
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DISC-3405 Shows 85% Phlebotomy Reduction
In the Phase 2 RESTORE-PV trial, mean phlebotomy events fell from 4.0 to 0.6 per 26 weeks (p<0.0001) among 13 patients completing 26 weeks; 61.5% remained entirely phlebotomy-free post-baseline.
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First-in-Class Mechanism Validated
DISC-3405 is the first anti-TMPRSS6 monoclonal antibody to demonstrate phlebotomy reduction in polycythemia vera, with hematocrit maintained stably below 45% through week 26 and a favorable safety profile.
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Two Programs Now Pivotal-Ready
Management stated DISC-3405 in PV and selcodebart in anemia of myelofibrosis are both advancing toward potential pivotal development, strengthening the company's hematologic oncology franchise.
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Year-End Catalysts Guided
Company expects a fuller RESTORE-PV update, initial Phase 1b sickle cell disease data for DISC-3405, and FDA end-of-Phase 2 meeting feedback on selcodebart by the end of 2026.
Analysis · IRON · Life Sciences
Disc Medicine reported the first clinical efficacy data for DISC-3405, its anti-TMPRSS6 antibody for polycythemia vera. In the Phase 2 RESTORE-PV trial, patients completing 26 weeks saw mean phlebotomy events drop from 4.0 to 0.6 per 26 weeks — an 85% reduction — with 61.5% remaining entirely phlebotomy-free. Hematocrit stayed below 45%, and the drug was well tolerated. This is the first monoclonal antibody targeting TMPRSS6 to show phlebotomy reduction in PV, a disease affecting roughly 150,000 U.S. patients. The data de-risks a second pipeline program and supports the company's plan to advance DISC-3405 toward pivotal development. Management also guided to additional catalysts before year-end: a fuller RESTORE-PV update, initial Phase 1b sickle cell data, and FDA end-of-Phase 2 feedback on selcodebart for anemia of myelofibrosis.
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At the time of this filing, IRON was trading at $78.20 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.9B. The 52-week trading range was $40.00 to $99.50. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.