Merck (MRK) announced detailed results from the Phase 2 CADENCE study, which evaluated the efficacy, safety, and tolerability of two doses (0.3 mg/kg and 0.7 mg/kg) of WINREVAIR (sotatercept-csrk). The trial focused on adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF).
In this distinct patient population, WINREVAIR demonstrated a statistically significant and clinically meaningful reduction in pulmonary vascular resistance (PVR) versus placebo (n=55) at week 24. Specifically, patients receiving the 0.3 mg/kg dose showed a reduction of 1.02 Wood units, while those on the 0.7 mg/kg dose experienced a reduction of 0.75 Wood units.
Important secondary endpoints explored in the study included six-minute walk distance (6MWD), echocardiographic measures, N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and time to clinical worsening (TTCW). In the 0.7 mg/kg arm, patients showed a 5.8-meter increase in 6MWD, which did not reach statistical significance (95% CI, -17.3, 28.9). Meanwhile, patients treated with the 0.3 mg/kg dose demonstrated a 20.3-meter increase from baseline in 6MWD (95% CI, 1.5, 39.1).
The safety profile observed in patients with CpcPH-HFpEF was generally consistent with the known safety profile of WINREVAIR in pulmonary arterial hypertension (PAH), supporting its potential as a therapeutic option in this patient population.
MRK closed regular trading at $119.63 on 27th March 2026 up $0.70 or 0.59%.
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