Bristol Myers Squibb (BMY) Shares Slide as Milvexian Heart Trial Halted After Interim Review – What Investors Need to Know Today (14 November 2025)

Bristol Myers Squibb and Johnson & Johnson end a key Phase 3 heart study for milvexian, sending BMY stock lower even as the pharma giant leans on a strong growth portfolio and fresh financing firepower.

Bristol-Myers Squibb Company (NYSE: BMY) is back in the spotlight today after the company and its partner Johnson & Johnson announced they will discontinue a major Phase 3 trial of their experimental blood thinner milvexian in acute coronary syndrome (ACS). The decision, based on a scheduled interim review showing the study was unlikely to hit its main goal, has pushed BMY shares lower and reignited debate about the company’s late‑stage pipeline and valuation. ^[1]

At the same time, new institutional ownership disclosures, recent Q3 2025 earnings, and a €5 billion euro‑denominated bond offering are giving investors fresh data points on the health of Bristol Myers Squibb’s balance sheet and long‑term strategy. ^[2]

Librexia ACS: Milvexian Heart Trial Stopped for Futility

Bristol Myers Squibb and Johnson & Johnson today confirmed they are stopping Librexia ACS, a large Phase 3 study evaluating milvexian on top of conventional antiplatelet therapy in patients who recently experienced an acute coronary syndrome event (such as heart attack or unstable angina). ^[3]

Key details from the company’s announcement and follow‑up coverage:

Reason for discontinuation:
An independent Data Monitoring Committee, in a pre‑planned interim analysis, concluded the trial was unlikely to meet its primary efficacy endpoint – time to first major adverse cardiovascular event (cardiovascular death, myocardial infarction, or ischemic stroke). ^[4]
Safety profile:
No new safety concerns were identified; the safety profile remained consistent with earlier milvexian data, according to Bristol Myers and J&J. ^[5]
Trial scale:
The Librexia ACS study was designed to enroll around 16,000 patients globally and run through late 2026 before the interim analysis led to early termination. ^[6]

Milvexian is a factor XIa inhibitor, part of a new class of oral anticoagulants designed to reduce the risk of dangerous blood clots while minimizing bleeding compared with today’s standard blood thinners. The ACS failure follows earlier setbacks in the same drug class, including Bayer’s asundexian program, and heightens questions about how broadly factor XIa inhibitors will work across cardiovascular indications. ^[7]

Still, Bristol Myers Squibb stresses that the ACS result doesn’t spell the end for milvexian. The company says it “remains confident in the potential of milvexian” in other settings and points out that the patient populations, background therapies, and dosing in its stroke and atrial fibrillation trials differ meaningfully from Librexia ACS. ^[8]

Two Milvexian Phase 3 Studies March On

Despite the ACS disappointment, Bristol Myers and Johnson & Johnson are continuing the other two large Phase 3 trials in the Librexia program: ^[9]

Librexia AF – compares milvexian to apixaban (Eliquis) in patients with atrial fibrillation.
Librexia STROKE – evaluates milvexian on top of antiplatelet therapy for secondary stroke prevention after ischemic stroke or high‑risk TIA.

Top‑line data from both AF and stroke studies are expected in 2026, making them critical upcoming catalysts for Bristol Myers Squibb and for the entire factor XIa class. ^[10]

Some analysts see an “incrementally negative” read‑through from the ACS failure to the stroke trial, which uses the same 25 mg twice‑daily dose, but view the atrial fibrillation indication as more distinct due to higher dosing and different clinical endpoints. ^[11]

Market reaction has been swift:

Premarket: Multiple outlets reported BMY down around 5–6% in premarket trading following the trial announcement, with Johnson & Johnson seeing a more modest dip. ^[12]
Intraday: As of early U.S. session trading, Bristol Myers Squibb shares are hovering in the mid‑$40s, down roughly 4–6% on the day, deepening a volatile stretch for the stock. (Real‑time values will continue to change during the trading session.)

For context:

Recent investor notes highlighted BMY’s 5%+ dividend yield and “blue‑chip pharma at a low multiple” status, reflecting skepticism about its patent cliff but also interest from income‑focused investors. ^[13]
Prior to today’s slide, BMY had bounced roughly 10–13% over the past month, helped by positive reaction to Q3 earnings and optimism around new drug approvals. ^[14]

Today’s move essentially gives back a chunk of that recent rebound as the market recalibrates expectations for milvexian’s commercial trajectory.

ACS Failure in Context: Another Test for Factor XIa

The Librexia ACS news lands in an already crowded and bruised landscape for factor XIa inhibitors:

Bayer previously halted its Phase 3 atrial fibrillation trial of asundexian for futility, cooling some of the early excitement around the class. ^[15]
With ACS now off the table for milvexian – at least in this trial design – much of the potential value now hinges on stroke prevention and atrial fibrillation, which represent larger commercial opportunities than ACS alone. ^[16]

For patients, the failure underlines how challenging it is to push outcomes beyond what can be achieved with aggressive antiplatelet therapy in ACS. For Bristol Myers, it reinforces the importance of diversification: the company cannot rely on any single late‑stage asset to offset looming revenue pressure from generic erosion elsewhere in the portfolio.

Under the Hood: Q3 2025 Results Show a Still‑Growing Core Business

Today’s sell‑off comes just two weeks after Bristol Myers Squibb reported better‑than‑expected Q3 2025 results, powered by its growth portfolio: ^[17]

Headline numbers (Q3 2025):

Revenue: $12.2 billion, up ~3% year‑over‑year and ahead of Wall Street estimates around $11.8 billion.
Adjusted EPS: $1.63, beating consensus of roughly $1.51–$1.52, though down versus $1.80 in the prior‑year quarter.
GAAP EPS: $1.08, up from $0.60 a year ago, reflecting changes in amortization and R&D charges.

Growth portfolio strength:

Opdivo (cancer immunotherapy): Sales rose about 7% to $2.53 billion, including early uptake of a newer subcutaneous formulation.
Eliquis (blood thinner, co‑developed with Pfizer): Revenue jumped ~25% to $3.75 billion.
Overall, the company’s growth portfolio generated about $6.9 billion, up roughly 17–18% year‑over‑year and helping offset sharp declines in older, patent‑exposed products such as Revlimid. ^[18]

On the back of these results, Bristol Myers raised its 2025 revenue guidance to roughly $47.5–$48.0 billion, while maintaining full‑year adjusted EPS guidance at $6.40–$6.60. ^[19]

In other words: fundamental performance had been trending better than feared heading into today, which is partly why the milvexian news feels like a setback rather than a collapse in the investment case.

Big Balance-Sheet Move: €5 Billion Euro Notes to Refinance Debt

Earlier this month, Bristol Myers strengthened its financial flexibility by pricing a €5 billion offering of senior unsecured notes via its Irish financing subsidiary, in five tranches maturing between 2030 and 2055. ^[20]

Key points:

Proceeds, together with around $3.0 billion in cash, are expected to fund a tender offer for existing notes, pay transaction costs, and support general corporate purposes.
The securities are fully and unconditionally guaranteed by Bristol‑Myers Squibb Company on a senior unsecured basis.

This move is primarily a refinancing and liability‑management exercise, not an aggressive leveraging step, and should help smooth the company’s debt maturity profile at a time when interest‑rate and patent‑cliff dynamics require careful capital allocation.

Institutional Investors Shuffle Positions in BMY

Alongside today’s trial news, investors are digesting a flurry of fresh 13F‑style institutional ownership updates that hit the tape:

Recent disclosures summarized by MarketBeat show: ^[21]

Candriam S.C.A.
- Sold 92,461 shares, trimming its BMY stake by 8.4% to just over 1.0 million shares worth about $46 million in Q2.
National Pension Service (South Korea)
- Reduced its position by 0.8%, selling ~41,465 shares and ending the quarter with 4.86 million shares valued around $225 million.
PNC Financial Services Group Inc.
- Cut its stake by 5.6% in Q2, now holding roughly 4.14 million shares (about 0.20% of the company) worth nearly $192 million.
Vestmark Advisory Solutions Inc.
- Slashed its holdings by 53.4%, to about 6,420 shares.
Cherokee Insurance Co
- Went the other way, initiating a new position of 30,600 shares valued at roughly $1.4 million.

Across these filings, one common thread is that institutional ownership remains high, at around 76% of the float, even as some large holders fine‑tune their exposure. ^[22]

Dividend, Valuation and Analyst Sentiment

From an income‑and‑valuation perspective, BMY still looks like a classic “value pharma” name in many models:

Dividend:
- Quarterly dividend of $0.62 per share, or $2.48 annually, implying a yield right around 5% at current prices and a payout ratio in the low‑80% range on forward earnings. ^[23]
Valuation:
- Recent analyses peg BMY’s P/E around 16–20x depending on whether one uses trailing or forward adjusted EPS, generally below peers in large‑cap pharma. ^[24]
- A Simply Wall St DCF model values the stock at about $127 per share, suggesting BMY could be trading at a 60%+ discount to its estimated intrinsic value — a sign, in their view, that the market may be over‑penalizing pipeline and patent‑cliff risks. ^[25]
Wall Street rating:
- BMY carries a consensus “Hold” rating from roughly 20–21 analysts, with only a minority recommending “Buy” or “Strong Buy.”
- Average 12‑month price targets cluster around the mid‑$50s, implying upside from current levels but also reflecting caution around long‑term growth. ^[26]

Put simply, many investors were already in “show‑me” mode before the ACS news; today’s setback will likely keep BMY in the value‑with‑hair bucket for fundamental stock pickers.

Strategic Growth: Oncology Network, Partnerships and RNA Bets

Beyond milvexian, Bristol Myers has been busy on the strategic collaboration front:

Sarah Cannon Research Institute (SCRI) collaboration expansion
This week, BMS highlighted an expanded strategic partnership with Sarah Cannon Research Institute, leveraging SCRI’s Accelero clinical trial delivery model to speed oncology trial enrollment across more than 200 community sites in the U.S. The goal: faster access to innovative cancer therapies for a broader patient base. ^[27]
BioNTech immuno‑oncology alliance
Earlier this month, BioNTech raised its 2025 revenue guidance after receiving initial payments from Bristol Myers under a cancer immunotherapy partnership that could total up to $11.1 billion over time. The collaboration centers on the T‑cell‑engaging candidate pumitamig and is intended to compete with heavyweights like Merck’s Keytruda. ^[28]

Taken together with recent acquisitions (such as the earlier‑announced deal for Orbital Therapeutics to bolster RNA medicines), these moves underscore BMS’s effort to rebuild and diversify its growth engine as older blockbusters lose exclusivity. ^[29]

What Today’s News Means for Patients and Investors

For patients with acute coronary syndrome

The Librexia ACS halt is disappointing because milvexian had the potential to become the first factor XIa inhibitor approved in ACS, possibly offering better protection from recurrent events with less bleeding risk. ^[30]
However, no new safety problems were seen, and standard ACS care — including established antiplatelets and other therapies — remains unchanged by today’s decision. ^[31]

For investors in BMY

Short‑term:
- Expect continued volatility as the market digests the lost ACS opportunity and recalibrates milvexian peak‑sales estimates.
- The sell‑off partially offsets optimism generated by a strong Q3, an attractive yield, and fresh balance‑sheet capacity from the euro note offering.
Medium‑term:
Key questions now center on:
- How much value remains in Librexia AF and Librexia STROKE (data in 2026).
- Whether BMS’s growth portfolio can keep compounding double‑digit sales growth. ^[32]
- How quickly new partnerships (BioNTech, SCRI and others) can translate into meaningful revenue as Revlimid and other legacy products decline. ^[33]

As always, this coverage is for information and news purposes only and is not investment advice. Anyone considering BMY or related securities should evaluate their own financial situation, risk tolerance, and time horizon and, if needed, consult a qualified financial professional.

Bristol-Myers Squibb stock tumbles after stroke drug trial sees mixed results