Shots:

• The P-III (METEORIC-HF) trial evaluates the effect of omecamtiv mecarbil vs PBO in 276 patients with HFrEF
• The results showed no effect of omecamtiv mecarbil on exercise capacity as determined by CPET @20wks., no effect on the 1EPs i.e., change in peak oxygen uptake (pVO2) on CPET from baseline to 20wk. The results were similar b/w the treatment arms and the safety profile was consistent with prior clinical trials including GALACTIC-HF
• The company has recently reported the US FDA acceptance of NDA for omecamtiv mecarbil, based on the results from the P-III (GALACTIC-HF) trial in ~8,000 patients with the same indication. The US FDA has assigned the PDUFA date of Nov 30, 2022

 Ref: Cytokinetics | Image: STAT News