Shots:
BMS has reported the 28wk. P-III (SCOUT-HCM) trial data assessing Camzyos (mavacamten) vs PBO in 44 pts (12 to <18yrs.) with symptomatic oHCM & NYHA class II-III symptoms, with plans to present 56wk. data in a future conference
Trial met its 1EP, showing reductions in Valsalva LVOT gradient at Wk. 28, supported by more pts…
Shots:
BMS reported topline P-III (SCOUT-HCM) trial data evaluating Camzyos (mavacamten) in 44 adolescents (12 to <18yrs.) with symptomatic oHCM, comprising a 28wk. PBO-controlled phase, an ongoing 28wk. active-treatment phase, & a 144wk. open-label LTE
Trial met its 1EP, showing reduced Valsalva LVOT gradient at Wk. 28, & achieved statistical significance across multiple 2EPs, incl.…
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012
The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available…

