According to analysts at BMO Capital Markets, non-obstructive hypertrophic cardiomyopathy would have meant a $1.3 billion label expansion opportunity for Camzyos.
Bristol Myers Squibb’s myosin blocker Camzyos failed to ease clinical burden and improve oxygen consumption in patients with non-obstructive hypertrophic cardiomyopathy, the pharma announced on Monday.
“This trial failure removes the opportunity for Camzyos in the 1/3 HCM patients who have the non-obstructive form of the disease,” analysts at BMO Capital Markets told investors in a Monday note. The late-stage stumble makes Camzyos’ label expansion into non-obstructive HCM “highly unlikely,” the analysts said.
BMS did not present specific data in the news release, only revealing that Camzyos “did not meet its dual primary endpoints” in the Phase III ODYSSEY-HCM study, including 48-week improvement in peak oxygen consumption and other symptoms, including shortness of breath and blood markers for potential heart failure. In terms of safety, BMS did not document any new signals of concern. The pharma has promised to share detailed results from ODYSSEY-HCM “in the future,” as per its Monday release.
Hypertrophic cardiomyopathy is a genetic disorder that causes heart muscle thickening. Depending on whether that thickening reduces flow of blood from the heart, the disorder can be classified as obstructive or non-obstructive.
For BMO, the failure did not come as a big surprise: “We’ve always framed this trial as more challenging.” The analysts pointed to the difficulties of demonstrating strong and significant treatment benefits in patients with the less severe, non-obstructive form of the disease.
Camzyos is an orally available cardiac myosin inhibitor that works by protein actions in muscular activation in the heart, with the goal of relaxing heart muscle and allowing the heart to fill with more blood. BMS gained ownership of Camzyos when it bought MyoKardia for $13.1 billion in October 2020. Two years later, the pharma secured the FDA’s approval for the drug, allowing its use in obstructive HCM.
According to the BMO note, ODYSSEY-HCM will not change Camzyos’ opportunity in obstructive HCM, retaining a roughly $2.7 billion sales potential at peak. Still, the late-stage failure is a blow to BMS’ cardio portfolio, which will now miss out on more an additional 33,000 patients with the non-obstructive form of the disease—approximately $1.3 billion in earnings. BMO called this missed opportunity “meaningful.”
BMS in the meantime is continuing to beef up its pipeline, with multiple “impactful catalysts” still lined up for 2025, according to BMO. “Top of mind for us remain the ARISE data evaluating the use of Cobenfy in adjunctive schizophrenia,” the analysts wrote, adding that this readout will come “any day now.” BMO is also looking forward to Cobenfy data in Alzheimer’s psychosis, expected in the latter half of 2025.
