Bristol Myers Squabble reports 56‑week SCOUT‑HCM results showing sustained LVOT gradient reduction in adolescents
Bristol Myers Squibb presented late‑breaker data from the phase 3 SCOUT‑HCM trial at the HCMS Scientific Sessions in Chicago. The study enrolled 44 patients aged 12‑<18 years, with 43 completing the 28‑week placebo‑controlled phase and then receiving Camzyos (mavacamten) through week 56. After 56 weeks, the average Valsalva LVOT gradient fell by about 48 mm Hg, and no participant’s left‑ventricular ejection fraction dropped below 50 %. The FDA had approved the drug for pediatric patients weighing at least 30 kg in September 2026.
Why it matters
The company says the data reinforce Camzyos’ efficacy and safety for pediatric oHCM, supporting its use under the REMS program. Investors may view the results as validation of the recent pediatric indication and a potential driver of future sales growth.
Key facts
- 1The SCOUT‑HCM trial (NCT06253221) enrolled 44 adolescents aged 12 to under 18 years, of whom 43 completed the initial 28‑week phase before all received Camzyos through week 56. clinicaltrialsarena.com
- 2Patients who received Camzyos for the full 56 weeks experienced an average reduction of 48.1 mm Hg in Valsalva LVOT gradient. ajmc.com
- 3Patients who switched from placebo to Camzyos at week 28 achieved a similar reduction in LVOT gradient. ajmc.com
- 4No patient in either arm had a left‑ventricular ejection fraction below 50 % during the 56‑week period. ajmc.com
- 5Treatment‑related adverse events numbered 5 and serious events 2 in the continuous Camzyos arm; the crossover arm reported 1 treatment‑related event and no serious events. ajmc.com
- 6The FDA approved Camzyos for pediatric patients weighing at least 30 kg in September 2026, making it the only approved therapy for pediatric oHCM in the United States. pharmacytimes.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.