Hemab starts Phase 3 trial in Glanzmann thrombasthenia, reports Q3 2026 results

Hemab Therapeutics reported third-quarter 2026 results and business updates on November 10, 2026. In November, the company began SOLARA, an open-label, single-arm, multicenter Phase 3 trial that plans to enroll about 75 participants ages 12 to 70 with Glanzmann thrombasthenia who have had at least four treated bleeding events in the prior 12 months.¹ The study design uses a 24-week run-in period on current on-demand standard of care, followed by a 48-week treatment period with sutacimig dosed at 0.2 mg/kg subcutaneously once weekly.¹ The FDA had recommended a randomized controlled design, and while the agency acknowledged Hemab's concerns about the feasibility of randomization in this rare disease, the company decided to proceed with the single-arm design given variability in bleeding rates and patient heterogeneity.¹ The first participants have been consented and are expected to enter the run-in period in the fourth quarter of 2026.¹

The company also disclosed early data from its Phase 2b trial of sutacimig in Factor VII deficiency. As of July 24, 2026, two participants with severe congenital FVIID had each received a single subcutaneous dose.¹ Baseline prothrombin time of 180 seconds or more fell by over 50% in both participants, and in the one participant with available PK/PD data, sutacimig produced roughly a fivefold sustained increase in endogenous total Factor VIIa, with exposure maintained through Day 22.¹ Updated data on all dosed participants are set to be presented at the ASH Annual Meeting on December 14, 2026.¹

In September, Hemab dosed its first participant in a Phase 1 trial of HMB-003, a fatty-acid-conjugated antifibrinolytic peptide, in a randomized, placebo-controlled, single-ascending-dose study in healthy volunteers for heavy menstrual bleeding.¹ The company expects initial clinical data from that trial in mid-2027.¹ For Von Willebrand disease, Hemab expects to report additional VELORA Pioneer Phase 1/2 data at the EAHAD Congress in February 2027.¹

On finances, cash, cash equivalents and marketable securities totaled $430.2 million as of September 30, 2026, down from $457.5 million as of June 30, 2026.¹ The company said this is sufficient to fund operations and capital expenditures into 2029.¹