“Secondary strokes continue to be a serious health risk for stroke patients and we believe these data demonstrated the potential of milvexian to address a key unmet need in this population,” Bristol Myers said.
Bristol Myers (BMY) – Get Bristol-Myers Squibb Company Report shares slumped lower Monday after the drugmaker published results from a mid-stage trial of its developing stroke treatment that failed to meet the primary goal of the study.
Bristol Myers said the phase 2 trial showed success in that its new drug candidate designed to prevent secondary strokes, an anticoagulant known as milvexian, showed a 30% relative risk reduction, as well as a favorable safety profile, when compared to placebos.
However, in data presented to the the European Society of Cardiology on Sunday, the study’s primary endpoint — which included by a dose response in terms of stroke incident as well as a brain infarction biomarker — was not met.
“Secondary strokes continue to be a serious health risk for stroke patients and we believe these data demonstrated the potential of milvexian to address a key unmet need in this population,” said Dr. Puneet Mohan, vice president, milvexian clinical development at Bristol Myers. “The AXIOMATIC-SSP results, together with previously reported findings from the Phase 2 study of milvexian in total knee replacement, further reinforce our confidence in this asset and we expect to initiate our broad Phase 3 program later this year.”
Bristol Myers shares were marked 6.35% lower in early Monday trading to change hands at $66.70 each, a move that nudge the stock into negative territory for the past six months.
Late last month, Bristol Myers boosted its full-year profit forecast to a range of between $4.20 to $4.30 per share following better-than-expected second quarter earnings that were powered in part by a 24% surge in its Eliquis blood clot treatment.
Bristol-Myers said non-GAAP earnings for the three months ending in June came in at $1.18 per share, up 16.8% from the same period last year and 10 cents ahead of the Street consensus forecast. Group revenues, Bristol-Myers said, rose 10.52% to $6.3 billion and again topped analysts’ estimates of $5.72 billion.