With the 2026 European Society of Cardiology (ESC) Congress in full swing, cardiologists and industry titans alike are gathering in Munich to soak in the latest developments in the cardiovascular space – including key readouts from late-stage studies.
To keep you up to date, Clinical Trials Arena has compiled the top datasets from the conference thus far.
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Cytokinetics’ Myqorzo posts Phase III HCM win
In a positive turn of events for patients with symptomatic, non-obstructive hypertrophic cardiomyopathy (HCM), Cytokinetics’ cardiac myostatin inhibitor, Myqorzo (aficamten), has met its primary endpoints in a late-stage trial – potentially priming it to become the first approved therapy in this indication.
According to results of the Phase III ACACIA-HCM study (NCT06081894), which were presented in a Hot Line session at ESC, Myqorzo met one of the trial’s primary endpoints by offering a significant 11.4-point baseline improvement in clinical measures of cardiomyopathy at 36 weeks, compared with the 8.4-point uptick seen in the placebo group. According to principal investigator, Ahmad Masri, patients began to accrue benefit in as little as 12 weeks.
At the same timepoint, patients given Myqorzo also experienced a significant uptick in maximal exercise performance, with their peak VO2 improving by 0.64 mL/kg/min, while peak volumes amongst the placebo group remained almost unchanged – meeting the study’s secondary main goal.
This outcome, Masri says, provides “really positive news” for patients with symptomatic, non-obstructive HCM, as it represents the first time a targeted medication has demonstrated clinical meaningful symptomatic and exercise capacity-based improvements.
It will also likely be welcomed by Cytokinetics, as it potentially provides a framework for Myqorzo’s label expansion into non-obstructive HCM following the drug’s US regulatory blessing in obstructive HCM back in December 2025.
HCM is genetic condition characterised by the thickening and stiffening of the heart muscle, which can reduce its ability to effectively pump blood around the body; especially in periods of exertion. Researchers currently estimate that around one in 500 individuals have HCM, of which around 30-70% have a non-obstructive version of the disease.
GlobalData, parent company of Clinical Trials Arena, forecasts that Myqorzo will secure blockbuster status in 2029.
Mixed results for Amgen’s Repatha in postmarketing trial
Another readout garnering attention at ESC 2026 is the mixed outcomes from a postmarketing study performed on Amgen’s star injectable PCSK9 inhibitor, Repatha (evolocumab).
Through the interventional Phase IV AMUNDSEN study (NCT04951856), researchers evaluated the potential benefit of Amgen’s Repatha (evolocumab) in helping patients to reach their LDL cholesterol level goals versus standard of care (SoC). This study enrolled patients who had been hospitalised for a heart attack and were undergoing a procedure to open narrowed coronary arteries.
During the trial, 82% of patients given Repatha met the LDL-C endpoint at 12 months compared with 40% in the standard care group – representing a significant benefit on this side of the equation. Those that achieved the LDL-C target also did so in nine weeks compared with 19 in the standard care group.
However, Repatha’s LDL-C-lowering prowess did not translate into improved clinical outcomes in this patient population, as there was no significant difference in the rate of all-cause deaths or cardiovascular hospitalisations between the treatment groups.
According to Hôpital Pitié-Salpêtrière’s Gilles Montalescot, the lack of Repatha’s impact on cardiovascular outcomes observed in AMUNDSEN suggests that the drug “may not have early clinically meaningful pleiotropic effects and the benefit of lipid lowering may require more time.”
Repatha’s mixed data comes as PCSK9 inhibitors see increased uptake within the cholesterol-lowering medicines space, despite their higher price tag compared with their generic counterparts, the statins. Following the approval of MSD’s Lipfendra, which is the first oral PCSK9-targeting therapy to make it to market, experts are enthusiastic about the drug’s market potential.
BMS details Phase III milvexian loss
While Bristol Myers Squibb (BMS) previously terminated the Phase III LIBREXIA-ACS study (NCT05754957) evaluating its cardiovascular disease hopeful, milvexian, in acute coronary syndrome due to a lacklustre interim analysis, the company has debuted detailed results from the trial that could signal positive readthrough to the drug’s other development programmes.
As per a subsequent analysis of the data collected, the rate of cardiovascular death, heart attack or ischaemic stroke remained largely similar across the milvexian and placebo-treated groups, with events of this nature occurring in 5.4% and 5.1% of patients, respectively, at a median follow-up of 10 months.
However, on a more positive note for BMS’s programmes involving milvexian in atrial fibrillation and secondary stroke prevention, researchers observed no difference in the levels of intercranial or fatal bleeding between the groups in this study.
In a statement, Gabriel Steg, LIBREXIA-ACS’s principal investigator, noted that this outcome was “reassuring”. He also added that there are notable distinctions between the LIBREXIA ACS study and the ongoing LIBREXIA AF and LIBREXIA Stroke trials, such as patient populations, disease pathology and endpoints.
BMS hopes that factor Xia (FXIa) inhibitor and next-generation anticoagulant, milvexian, can carry on the legacy built by its blockbuster predecessor, Eliquis (apixaban), which is nearing its loss of market exclusivity. In a recent earnings call, analysts had questions aplenty on milvexian, pointing to their interest in the asset as it progresses through late-stage development.
