Clinical trialsCompany release

Hemab begins single-arm Phase 3 SOLARA trial of sutacimig in Glanzmann thrombasthenia

🇺🇸 Hemab Therapeutics Holdings, Inc. (COAG) · Tue 10 Nov 2026

The company reported Q3 2026 results, saying it opted for a single-arm pivotal design despite the FDA recommending it consider randomisation, citing feasibility in a rare disease.

Hemab Therapeutics reported its third-quarter 2026 results on 10 November 2026 and said it has started SOLARA, a pivotal Phase 3 trial of sutacimig in Glanzmann thrombasthenia. The study is single-arm, and the drug is given as a weekly subcutaneous injection.

The trial design departs from what the US Food and Drug Administration had suggested. According to the company, the agency recommended that it consider a randomised design. Hemab chose a single-arm approach because of concerns about feasibility in such a rare disease. The source summary does not give further detail on how the FDA views the final design.

Hemab also reported progress outside Glanzmann thrombasthenia. It has dosed the first participant in a Phase 1 trial of HMB-003 for heavy menstrual bleeding, and it has released first clinical data for sutacimig in Factor VII deficiency.

No enrolment targets, endpoints, efficacy figures or financial numbers were available in the material reviewed for this article.

What it means for your team

  • Regulatory teams in rare disease should note the gap between the FDA's recommendation to consider randomisation and the sponsor's single-arm pivotal design, as the design may draw scrutiny at review.
  • Market-access teams will want to see how a single-arm dataset is later assessed by payers and health technology assessment bodies, which often look for comparative evidence.
  • Sutacimig's first clinical data in Factor VII deficiency suggest the programme may extend beyond Glanzmann thrombasthenia, though only early information is available.

Company's press release (SEC filing): Hemab Therapeutics Holdings, Inc. ↗

Article written by VigiEye from the official source (Hemab Therapeutics Holdings, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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