Clinical trialsCompany release

Braveheart Bio reports Q3 results, 52-week BHB-1893 HCM data and new trial plans

🇺🇸 Braveheart Bio, Inc. (BRVE) · Tue 10 Nov 2026

The US biotech reported $503.5m in cash after its August IPO, and said FDA feedback supports a fixed-dose Phase 2b trial and a Phase 3 study in non-obstructive HCM.

Braveheart Bio, Inc. reported third-quarter 2026 results on 10 November, stating that it held $503.5 million in cash. The company said this funds operations into 2029, following its initial public offering in August.

The company also presented 52-week open-label data for BHB-1893, a cardiac myosin inhibitor for hypertrophic cardiomyopathy (HCM), at the American Heart Association (AHA) 2026 meeting. Braveheart reported no on-treatment severe or serious adverse events in the data set. The source summary does not give patient numbers or efficacy endpoints, and open-label data carry the usual limits of uncontrolled designs.

Braveheart said its Phase 3 LIONHEART-HCM trial is currently enrolling patients. Following what it described as supportive feedback from the US Food and Drug Administration, it plans to begin a fixed-dose Phase 2b trial in the first half of 2027.

In the same period, the company intends to start a Phase 3 trial, NOBLEHEART-HCM, in non-obstructive HCM. The company did not provide further design details in the information available.

What it means for your team

  • Regulatory teams tracking cardiac myosin inhibitors should note that FDA feedback has reportedly supported both a fixed-dose Phase 2b trial and a Phase 3 programme in non-obstructive HCM.
  • Safety teams should treat the 52-week finding of no on-treatment severe or serious adverse events as preliminary, since it comes from open-label data and full details were not provided.
  • Market-access and competitive-intelligence teams can note that the 2029 cash runway and 2027 trial starts indicate the programme's development timeline.

Company's press release (SEC filing): Braveheart Bio, Inc. ↗

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

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