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Edgewise Therapeutics Reports the P-II (CIRRUS-HCM) Trial Data on EDG-7500 for Obstructive and Nonobstructive Hypertrophic Cardiomyopathy

Shots: Edgewise has reported the 12wk. P-II Part D (CIRRUS-HCM) trial data assessing EDG-7500 (PO) in obstructive (oHCM; n=20) and nonobstructive (nHCM; n=33) Hypertrophic Cardiomyopathy, where pts in both groups received doses ranging from 25 to 150mg In oHCM pts, EDG-7500 showed 90% pts had improved LVOT-G, 74% achieved NT-proBNP normalization, or ≥50% reduction, KCCQ-OSS…

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Cytokinetics Reports the EC Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The EC has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with first EU launch expected in Germany by Q2’26 Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by…

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Cytokinetics Launches Myqorzo in the US for Obstructive Hypertrophic Cardiomyopathy

Shots: The US FDA approved Myqorzo (aficamten) is now commercially available in the US for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms Myqorzo is a QD, oral cardiac myosin inhibitor available in 5, 10, 15, and 20 mg tablets and directly targets hypercontractility and LVOT obstruction…

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Sanofi

Sanofi Secures China Approval for Myqorzo and Redemplo in oHCM and FCS

Shots: China’s NMPA has approved Sanofi-licensed Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for triglyceride reduction in adults with familial chylomicronemia syndrome (FCS) on dietary control The approval of Myqorzo was based on the pivotal P-III (SEQUOIA-HCM) study in pts with symptomatic oHCM, while Redemplo’s approval was supported by…

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BMS

BMS Reports P-III (SCOUT-HCM) Trial Findings on Camzyos for Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

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.…

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