Bristol Myers Squibb reported that its Phase III adolescent trial of Camzyos (mavacamten) in obstructive hypertrophic cardiomyopathy (oHCM) met its primary endpoint, demonstrating a mean increase in peak oxygen consumption (peak VO2) of 2.8 mL/kg/min over placebo at 24 weeks (p<0.001). The trial enrolled 120 patients aged 12–17 across 30 centers in North America and Europe. Secondary endpoints showed a 35% reduction in NT-proBNP levels versus baseline and a 40% improvement in New York Heart Association (NYHA) functional class. The safety profile was consistent with adult studies, with no new serious adverse events noted.

The positive adolescent data is expected to broaden Camzyos’ label beyond adult oHCM, potentially adding 8,000–10,000 juvenile patients in the U.S. and EU over the next five years. Cardiovascular disease accounts for roughly 15% of Bristol Myers Squibb’s revenue mix, or approximately $7.2 billion annually. Successful label expansion could drive incremental peak sales of $500 million by 2030, according to management guidance. The company plans to submit an sBLA to the FDA by Q4 2026 and file in Europe in early 2027.

Despite the Camzyos win, Bristol Myers Squibb has faced recent setbacks with its late-stage oncology candidate BMS-986393, which failed to meet the primary endpoint in a Phase III lung cancer trial in July 2025. In addition, Opdivo faces intensifying competition from Roche’s Tecentriq and Merck’s Keytruda in multiple indications. These challenges have prompted management to reallocate R&D spend, with cardiovascular research rising to 18% of total R&D investment in fiscal 2025 from 12% in fiscal 2023.