On July 14, Bristol-Myers Squibb rose 3.12% in regular trading, trading at $59.37/share, with turnover of $475 million. The gain was driven by the announcement that the U.S. FDA has accepted the company's new drug application for mezigdomide in combination with carfilzomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma.
The filing was supported by Phase 3 trial data demonstrating a statistically significant improvement in progression-free survival. The trial showed the combination therapy reduced the risk of disease progression or death by 52%, extending median progression-free survival to 18 months versus 8.3 months for the standard-of-care arm. The overall response rate reached 80.2% compared with 53.4% for the control group. The FDA has assigned a PDUFA target action date of May 13, 2027.
The mezigdomide program is part of Bristol-Myers Squibb's CELMoD franchise, which RBC Capital Markets previously highlighted as an often-overlooked pipeline with several potential opportunities that could support upside for the stock.
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