This section highlights FDA-related milestones and regulatory updates for drugs developed by Hemab Therapeutics (COAG).
Over the past two years, Hemab Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HMB-001, HMB-003, and HMB-002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
HMB-001 FDA Regulatory Events
HMB-001 is a drug developed by Hemab Therapeutics for the following indication: in Glanzmann Thrombasthenia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HMB-001
- Announced Date:
- November 9, 2026
- Indication:
- in Glanzmann Thrombasthenia
Announcement
Hemab Therapeutics announced the initiation of SOLARA, a pivotal Phase 3 trial evaluating sutacimig (HMB-001) as a potential prophylactic treatment for people with Glanzmann thrombasthenia (GT).
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HMB-003 FDA Regulatory Events
HMB-003 is a drug developed by Hemab Therapeutics for the following indication: Therapy for the Management of Heavy Menstrual Bleeding.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HMB-003
- Announced Date:
- September 17, 2026
- Indication:
- Therapy for the Management of Heavy Menstrual Bleeding
Announcement
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.
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HMB-002 FDA Regulatory Events
HMB-002 is a drug developed by Hemab Therapeutics for the following indication: in Von Willebrand disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HMB-002
- Announced Date:
- July 14, 2026
- Indication:
- in Von Willebrand disease
Announcement
Hemab Therapeutics today presented clinical and preclinical data from sutacimig in GT and FVIID at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris, France. This follows the presentation of new clinical data from HMB-002 in Von Willebrand disease and the announcement of the HMB-003 program on Sunday, July 12.
AI Summary
Hemab Therapeutics presented new clinical and preclinical data on sutacimig at the ISTH 2026 Congress in Paris. In people with Glanzmann thrombasthenia (GT), Phase 2 long-term extension results showed that sutacimig continued to reduce bleeding over time, with safety and tolerability that were manageable. The company said it plans to start a Phase 3 trial in the second half of 2026 using an agreed weekly dosing schedule.
Preclinical findings also showed sutacimig restored thrombin generation in Factor VII deficiency, even under disease-like conditions, supporting its possible use as a broad hemostatic treatment. In separate GT natural history studies, researchers confirmed that bleeding can be a lifelong burden and that preventive therapy is still underused, highlighting the need for better prophylaxis. The congress featured nine Hemab presentations in total, including data on HMB-002 and the HMB-003 program.
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