Zinger Key Points
- Camzyos missed both primary endpoints in the Phase 3 ODYSSEY-HCM trial for nHCM.
- No new safety concerns were identified in the 48-week clinical study.
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Bristol Myers Squibb & Co BMY on Monday announced topline data from the Phase 3 ODYSSEY-HCM trial of Camzyos (mavacamten) for symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM).
The trial did not meet its dual primary endpoints of changes from baseline to Week 48 compared to placebo in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2).
No new safety signals were observed.
Bristol Myers Squibb will work with key investigators to share detailed results with the scientific community in the future.
Camzyos is the first and only cardiac myosin inhibitor approved in the U.S., indicated for adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms, and in the European Union, indicated for symptomatic (NYHA, class II-III) oHCM in adult patients.
William Blair writes that the press release specifically calls out that the results of the studies of mavacamten in oHCM and nHCM demonstrate that they are unique diseases, suggesting this was not a "near-miss" or one in which trends were observed.
While expansion into the nHCM patient population would have been a clear positive for Camzyos, analyst Matt Phipps did not include this opportunity in current estimates for Camzyos since the results of the Phase II MAVERICK-HCM study showed little benefit on the primary endpoints in the ODYSSEY-HCM trial.
The analyst says the trial's failure may be more attributable to differences in disease biology and sees minimal impact to Camzyos in oHCM.
Results from the Phase 2 MAVERICK-HCM trial of Camzyos showed minimal improvements in pVO2 and symptoms.
“While full results from the ODYSSEY-HCM trial will be needed to determine if the results read through to other drugs with the same mechanism being studied in nHCM, Cytokinetic Inc's CYTK aficamten), we believe the Phase 2 MAVERICK-HCM and Phase 3 ODYSSEY-HCM trials suggest it could read through to the class,” William Blair writes.
Bristol Myers Squibb Stock Prediction For 2025
Equity research can be a valuable source of information for learning about a company's fundamentals. Analysts create financial models based on the fundamentals and expected future earnings of a company to arrive at a price target and recommendation for the stock.
Shares of Bristol-Myers Squibb have an average 1-year price target of $58.2, representing an expected upside of 15.68%.
Because of differences in assumptions, analysts can arrive at very different price targets and recommendations. No analysts have bearish recommendations on Bristol-Myers Squibb, while No analysts have bullish ratings. The street high price target from Citigroup is $65.0, while the street low from UBS is $54.0.
Price Action: BMY stock is down 2.89% at $49.89 at the last check Tuesday.
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