Hemab reports Q2 2026 results as FDA clears sutacimig path to Phase 3 in Glanzmann thrombasthenia

Hemab Therapeutics announced on August 11, 2026 that the FDA has endorsed the company's clinical data package as sufficient to proceed to a Phase 3 pivotal trial in Glanzmann thrombasthenia with a dose of 0.2 mg/kg once weekly, and the company plans to initiate the Phase 3 trial in the second half of 2026.¹ This followed Phase 2 long-term extension data for sutacimig presented at ISTH 2026 showing clinically meaningful and sustained bleed reduction in 34 participants at a median timepoint of 6.9 months and up to 15.9 months of exposure.¹ Ninety-two percent of participants who had bled during run-in saw reduced treated bleed rates on sutacimig, with mean high-intensity annualized treated bleed rate down 62% over the treatment and extension period, and about 84% in the low-dose weekly cohort.¹ Adverse events were mostly mild to moderate, with no Grade 3 or higher related events, though three participants had Grade 2 thromboembolic events managed with routine anticoagulation.¹

For Factor VII deficiency, the company expects to report Phase 2 data in late 2026 or early 2027.¹

On HMB-002 for Von Willebrand disease, the ongoing VELORA Pioneer Phase 1/2 trial showed a peak increase of at least 2.4-fold in VWF and Factor VIII, and across single ascending dose cohorts 8 of 9 evaluable patients had zero treated bleeds in the 28 days following dosing, with mean ATBR of 1.6 versus a baseline of 20.1.¹ Additional trial data are expected in late 2026 or early 2027.¹

The company also unveiled HMB-003, a novel fatty-acid-conjugated peptide antifibrinolytic designed to stabilize clots, beginning in heavy menstrual bleeding.¹ First-in-human studies are planned for the second half of 2026, with initial clinical data expected mid-2027.¹

On finances, cash, cash equivalents and marketable securities totaled $457.5 million as of June 30, 2026, up from $163.5 million at March 31, 2026, reflecting $317.2 million in net IPO proceeds from May 2026.¹ The company said this funding is expected to support operations into 2029.¹