By Josh Nathan-Kazis
Bristol Myers Squibb can't catch a break.
The big pharma company has faced down one late-stage trial failure after another this year. A Phase 3 trial of its schizophrenia drug Cobenfy failed in April, as did a separate Phase 3 trial of its heart drug Camzyos. Its cancer drug Opdualag failed in a Phase 3 trial in melanoma patients in February, and its drug Reblozyl failed in a Phase 3 trial in July.
Now, investors can add one more late-stage failure to that list.
Early Friday, Bristol said it had decided to stop one of its ongoing Phase 3 trials testing an experimental blood thinner called milvexian after a data monitoring committee said that the trial was likely to fail.
Bristol is developing milvexian in partnership with Johnson & Johnson. The companies are testing milvexian in two other ongoing Phase 3 trials, and said Friday that those tests will continue. Analysts have been more focused on the other trials, which test the drug in more potentially lucrative indications.
In a statement, Bristol's head of immunology and cardiovascular medicines drug development, Roland Chen, said that the company's belief in the other two studies "remains high and is rooted in robust data from large Phase 2 clinical studies."
Bristol shares were down 3.1% on Friday, after falling as much as 5.2% at midmorning. The stock is now down 17% on the year. Johnson & Johnson stock was flat on Friday.
The stopped trial administered milvexian to patients who had recently had an acute coronary syndrome event, a reduction in blood flow to the heart that can cause a heart attack. It tested whether the drug cut the risk of a future heart attack or stroke in those patients.
An independent data monitoring committee "determined the trial is unlikely to meet the primary efficacy endpoint," Bristol said.
The other ongoing Phase 3 milvexian trials test whether the drug can prevent stroke in patients with atrial fibrillation, and whether the drug can prevent the recurrence of stroke in patients who have already had a stroke.
Analyst said Friday that investors hadn't been focused on milvexian as a treatment for acute coronary syndrome, but that the stopped trial was worrying for its potential implications for the atrial fibrillation indication.
"The fallout will come from interpretation of what the early study discontinuation will mean for Phase 3 studies of milvexian in secondary stroke prevention (LIBREXIA-STROKE) and atrial fibrillation (LIBREXIA-AF)," Raymond James analyst Sean McCutcheon wrote Friday, naming the two other milvexian trials.
William Blair analyst Matt Phipps wrote Friday that the stopped acute coronary syndrome trial is very similar to the stroke prevention trial. Both used the same dose level of milvexian. "We believe today's news has an incrementally negative read-through" to the stroke trial, he wrote.
The atrial fibrilation trial, however, is different, Phipps said. Investors have been most focused on milvexian as an atrial fibrillation treatment, since the condition is relatively common in the U.S. The atrial fibrillation trial tests a higher dose of milvexian, and Phipps wrote it "may have less read-through from today's setback."
That's a potentially good sign for Bristol, and likely the reason the stock's reaction has been muted on Friday.
Phipps models $703 million in milvexian revenue for Bristol in 2028. He said his model won't change, since it hadn't included any contribution from the acute coronary syndrome indication.
Like other Big Pharma names, Bristol is heading for a wave of significant patent expirations. Its top-selling drugs, the blood thinner Eliquis and the cancer medicine Opdivo, will see their patents expire in 2028, and patents on its cancer medicine Yervoy expire this year. Analysts see its sales 24% falling from 2024 through 2030, according to FactSet.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.
(END) Dow Jones Newswires
November 14, 2025 12:35 ET (17:35 GMT)
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