Hemab Therapeutics Holdings Inc

Hemab Therapeutics Holdings Inc(COAG)资讯与事件

$34.815

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COAG 资讯

COAG 事件

9/17 08:30

Hemab Therapeutics Doses First Volunteer in HMB-003 Trial

Hemab Therapeutics announced that the first healthy volunteer has been dosed in its Phase 1 clinical trial evaluating HMB-003, an investigational therapy for the management of heavy menstrual bleeding.

8/11 07:30

Hemab CEO Announces New Program HMB-003 Addressing Heavy Menstrual Bleeding

"This was a very productive quarter for Hemab with continued execution across our pipeline," said Benny Sorensen, CEO of Hemab. "We had a significant presence at ISTH 2026, presenting data from all our programs. The strong interest we saw in that data underscores both the significant unmet need in bleeding disorders and the potential for our clinical and preclinical pipeline to redefine the standard of care in this space. We are particularly pleased to announce a new program, HMB-003, where we are addressing heavy menstrual bleeding, an indication that affects millions of women globally. HMB-003 is another example of how Hemab is developing treatments that could redefine care across high-unmet-need bleeding disorders. We look forward to providing additional updates on our programs later this year."

7/12 10:00

Hemab Therapeutics Presents HMB-002 Clinical Data

Hemab Therapeutics presented new clinical data from HMB-002 in Von Willebrand disease, VWD, and announced the HMB-003 program at the International Society on Thrombosis and Haemostasis, ISTH, 2026 Congress in Paris, France. HMB-002 is designed to address the underlying biological drivers of VWD through a non-replacement approach-elevating the body's endogenous levels of VWF and FVIII rather than infusing exogenous factor-with early first-in-human data building a compelling case for this paradigm shift. Extended half-life supporting infrequent dosing: Pharmacokinetic analysis confirmed dose-dependent increase in Cmax with prolonged duration. Dual VWF and FVIII elevation: In all dose cohorts tested, VWF and FVIII were elevated in a dose-dependent manner. In cohort A3, greater than or equal to2.4-fold elevation in both VWF and FVIII was achieved and accompanied by restoration of thrombin generation, shortening of APTT, and stable multimer distribution. Emerging safety profile: Most treatment-emergent adverse events were mild to moderate in severity, no serious TEAEs occurred, no events were considered related to HMB-002, and no participant discontinued the study due to TEAEs. Preliminary clinical observations: The single ascending dose part of the study wasn't designed to measure efficacy, so clinical observations should be considered descriptive in nature. HMB-003 is a novel fatty-acid-conjugated peptide antifibrinolytic, designed to stabilize clots and reduce bleeding across multiple settings, beginning in heavy menstrual bleeding, with preclinical data supporting potent, selective antifibrinolytic activity and extended duration of action. Potent and selective plasmin inhibition: HMB-003 directly inhibits plasmin at its active site and inhibits fibrinolysis across both tPA- and uPA-driven pathways, while showing no effect on thrombin generation, platelet function, or coagulation in nonclinical studies. Extended antifibrinolytic activity: Following a single subcutaneous dose in minipigs, HMB-003 achieved peak plasma levels within hours and sustained antifibrinolytic activity for approximately one week, supporting the potential for cycle-matched dosing in heavy menstrual bleeding.

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