Announcement • Jul 14
Hemab Therapeutics Presents Clinical And Preclinical Data From Sutacimig In Glanzmann Thrombasthenia And Factor VII Deficiency At ISTH 2026 Congress Hemab Therapeutics presented clinical and preclinical data from sutacimig in Glanzmann thrombasthenia (GT) and Factor VII deficiency (FVIID) at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris, France. Sutacimig Phase 2 long-term extension (LTE) data show sustained bleed reduction and manageable safety and tolerability; Phase 3 initiation planned Second Half 2026. Preclinical data for sutacimig in Factor VII deficiency (FVIID) demonstrate restoration of thrombin generation under disease-mimicking conditions and support its potential as a pan-hemostatic agent. Natural history studies in Glanzmann thrombasthenia (GT) confirm lifelong bleeding burden and critical underutilization of prophylaxis, underscoring the urgent need for preventive treatment. ISTH 2026 included nine total Hemab-led presentations delivering new clinical and preclinical data across sutacimig, HMB-002, and HMB-003. Sutacimig Phase 2 LTE data—reflecting treatment of 34 patients at a median of 6.9 months and up to 15.9 months of exposure—demonstrate a sustained prophylactic effect and reinforce the potential to shift people living with GT from reactive, IV-dependent treatment to subcutaneous prophylaxis, with regulatory alignment to proceed to Phase 3 with an agreed weekly regimen. Clinically meaningful annualized treated bleeding rate (ATBR) reduction: 92% of participants who had bled during the run-in experienced reductions in treated bleed rates on sutacimig, and among participants who reported bleeding events that required transfusions, rFVIIa or hospitalization (high intensity bleeding events) within 12 months prior to receiving sutacimig, the mean high intensity annualized treated bleed event rate was reduced by 62% over the treatment and extension period. In all dose cohorts, the mean ATBR was reduced over the treatment and extension period, and in the low dose weekly regimen cohort, the mean ATBR was reduced by approximately 84%. First surgical use data: Three participants underwent procedures (two invasive surgeries and one dental procedure), all with successful hemostatic outcomes; one required a single post-procedure dose of recombinant Factor VIIa (rFVIIa). Safety: Adverse events were predominantly mild to moderate. There were no Grade 3 or higher related adverse events. Three participants experienced Grade 2 thromboembolic events. These occurred in participants assigned to dose cohorts associated with higher exposure and/or with multiple concurrent risk factors; all were managed with routine anticoagulation and were resolved or resolving at the datacut. Robust Phase 1/2 data: Enabled identification of a weekly Phase 3 dose with potential to optimize ATBR reduction while avoiding high peak exposures associated with TE in Phase 1/2. FDA has endorsed the clinical data package as sufficient to proceed to Phase 3 with a dose of 0.2mg/kg First Quarter week. Preclinical data for sutacimig in FVIID: Demonstrate restoration of thrombin generation under disease-mimicking conditions and support its potential across multiple indications, with retained binding expected for >90% of severe-to-moderate FVIID database variants and confirmed binding across 22 of 25 tested variants (88%), supporting broad patient applicability for the ongoing Phase 2 study. Lifelong GT bleeding burden (GT360, N=117): Over 90% of pediatric, adolescent, and young adult patients experience at least one bleed per week; 72% of those aged 40 and older still bleed weekly. Prevalence of depressive symptoms is 3-4x for the general population (32% vs. ~8–10%), with a stepwise relationship between bleeding frequency and psychological burden. Prophylaxis critically underutilized (ATHN Transcends, N=49): In 16.6 prospective patient-years of follow-up, mean ABR was 25.9 among participants experiencing bleeds and 44% of bleeds went untreated. Only 14% of patients received any prophylaxis. Glanzmann thrombasthenia (GT) is a severe bleeding disorder marked by debilitating, sometimes life-threatening bleeding episodes. Results from an international natural history study (Glanzmann's 360) revealed the substantial burden of this disease: 88% of the 117 participants reported at least one bleed in the previous week with 65% requiring a bleed-related hospital visit in the prior six months. Live News • Jul 13
Hemab Therapeutics Unveils New Data and Pipeline Program at ISTH 2026 Congress Hemab Therapeutics presented new clinical data for HMB-002 in Von Willebrand disease at the ISTH 2026 Congress. The results showed proof of mechanism with dose-dependent increases in Von Willebrand Factor and Factor VIII, along with normalization of thrombin generation and APTT that supports potential monthly subcutaneous dosing.
The company also introduced HMB-003, a non-hormonal direct plasmin inhibitor designed for extended antifibrinolytic activity, initially targeting heavy menstrual bleeding. This program adds a new mechanism and indication to Hemab Therapeutics’ pipeline.
Hemab Therapeutics’ stock trades at US$38.03, with the share price up 52.2% over the past 30 days, reflecting strong recent interest as the pipeline update becomes part of the investment debate.
These data and the new program expand the clinical story around Hemab Therapeutics, but investors still need to weigh typical drug development risks such as future trial outcomes, regulatory decisions and eventual commercial uptake. 
