Braveheart Bio posts 52-week oHCM data, pipeline updates with Q3 results

Braveheart Bio reported unaudited third quarter 2026 results on November 10, 2026, alongside a business update covering its cardiac myosin inhibitor BHB-1893. At the AHA Scientific Sessions 2026, Braveheart Bio and partner Hengrui Pharma presented 52-week open-label extension data from the Phase 2 study of BHB-1893 in 42 patients with obstructive HCM in a late-breaking oral presentation.¹ Patients showed average gains of 2.7 mL/kg/min in peak oxygen uptake and 17.3 points on the KCCQ Clinical Summary Score from the extension's baseline.¹ The company also said by Week 1, before any dose titration, 67% of patients had a Valsalva LVOT gradient under 30 mmHg, and 90% reached that threshold at some point over the 52 weeks.¹ At one year, 57% of patients were still on the initial 40 mg twice-daily dose.¹ No on-treatment severe or serious adverse events were reported.¹

On the pipeline, the global Phase 3 LIONHEART-HCM trial in obstructive HCM is enrolling, with an interim LVOT gradient analysis at Week 12 expected in the second half of 2027.¹ Braveheart Bio completed its end-of-Phase 2 meeting with the FDA and plans to start the Phase 3 NOBLEHEART-HCM trial in non-obstructive HCM in the first half of 2027.¹ A fixed-dose Phase 2b study, TRUEHEART-HCM, is also set to begin in the U.S. in the first half of 2027 after the company received supportive FDA feedback on the fixed-dose approach.¹ Separately, Hengrui Pharma has completed enrollment in its own Phase 3 oHCM trial in China, with topline data expected in the first half of 2027.¹

On finances, Braveheart Bio held $503.5 million in cash, cash equivalents and investments as of September 30, 2026, up from $89.2 million at year-end 2025, which it said should fund operations into 2029.¹