Bristol-Myers Squibb Company

The Trump administration has selected 10 companies, including AbbVie, Amgen, Pfizer, and GSK, for a new pilot program that tests a rebate model for drugs purchased under a federal program benefiting uninsured and low-income patients. The 340B Rebate Model Pilot takes effect on January 1 and allows the selected manufacturers to verify and pay rebates for 21 discounted drugs purchased under the government's 340B drug pricing program, rather than offering savings upfront as under the current discount model. The participating drugmakers are AbbVie, Amgen, Astellas, AstraZeneca, Bristol Myers, GSK, Merck, Pfizer, and Teva. The Health Resources and Services Administration, the HHS unit overseeing the program, said the approach helps address compliance concerns proactively rather than relying primarily on retrospective reviews, audits, and dispute resolution processes. The pilot marks the Trump administration's second attempt to overhaul the decades-old drug discount program, after a federal judge blocked HRSA's first 340B rebate pilot following a case brought by hospital groups last year.

The U.S. Food and Drug Administration has approved an expanded indication for Bristol Myers Squibb's CAMZYOS (mavacamten) to treat symptomatic obstructive hypertrophic cardiomyopathy in adults and pediatric patients weighing 30 kg (66 lbs) or more, making it the only FDA-approved therapy for oHCM in a pediatric population and giving it the broadest indication of any cardiac myosin inhibitor. The approval is based on positive results from the Phase 3 SCOUT-HCM trial, which evaluated CAMZYOS (n=23) versus placebo (n=21) in patients aged 12 to under 18 years with symptomatic NYHA Class II-III oHCM. CAMZYOS met the trial's primary endpoint, showing a statistically significant reduction in Valsalva left ventricular outflow tract gradient at Week 28 compared with placebo, with a least-squares mean difference from placebo of minus 48.0 mm Hg (95% CI, minus 67.7 to minus 28.3; P<0.0001). No patients in SCOUT-HCM experienced left ventricular ejection fraction below 50%, no adverse events led to treatment discontinuation, and no new adverse reactions were identified beyond the safety profile observed in adults. CAMZYOS was first approved by the FDA in 2022 for adults with symptomatic NYHA class II-III oHCM and has been prescribed by more than 5,000 healthcare providers to over 25,000 patients in the U.S. alone; the pediatric data is now being discussed with multiple global regulatory authorities for potential pediatric indications.

Bristol-Myers Squibb announced on September 8 positive Phase 2 results from its registrational QUINTESSENTIAL trial of arlocabtagene autoleucel, or arlo-cel, in adult patients with quadruple-class exposed relapsed and refractory multiple myeloma. The trial met its primary endpoint, showing a statistically significant and clinically meaningful overall response rate along with strong complete response rates in heavily pretreated patients who had received three or more prior lines of therapy, and the safety profile was consistent with existing CAR T and GPRC5D-targeting therapies. The readout comes as BMS works to expand its Growth Portfolio against mature-brand erosion; in the second quarter the company reported a 6% revenue increase to $13.0 billion, with Growth Portfolio revenues up 15% to $7.6 billion, and management raised full-year 2026 revenue guidance to $49.0 to $50.0 billion and non-GAAP EPS expectations to $6.75 to $7.00. The company still faces generic competition in its Legacy Portfolio, which fell 4% to $5.4 billion in the quarter, while full-year operating expenses are projected at $16.5 billion and non-GAAP gross margins contracted from 72.6% to 71.4%. BMS said arlo-cel provides a potentially differentiated cell therapy platform to address severe unmet needs in oncology.

Bristol Myers Squibb announced the first presentation of results from the pivotal Phase 3 EXCALIBER-RRMM trial showing that ZENBEXUS, or iberdomide, in combination with daratumumab and dexamethasone doubled minimal residual disease-negative complete response rates compared with daratumumab, bortezomib and dexamethasone, at 41.1% versus 20.7%. The data, presented at the 23rd Annual Meeting of the International Myeloma Society in Glasgow and simultaneously published in The Lancet Oncology, covered 420 evaluable patients at a median follow-up of 15.7 months and showed a statistically significant improvement with an odds ratio of 2.75. Overall response rate was 88.9% with the ZENBEXUS-based triplet versus 76.1% for the comparator, while complete response or better nearly doubled at 45.9% versus 24.9%. Based on these results, ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone received accelerated approval from the U.S. Food and Drug Administration on August 13 for adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, marking the arrival of a new treatment class. Evaluation of the dual primary endpoint of progression-free survival in the confirmatory analysis cohort of 800 patients is ongoing.

Bristol-Myers Squibb has selected Onco360 to join the restricted specialty pharmacy network for ZENBEXUS, its newly approved therapy for certain multiple myeloma patients. ZENBEXUS will be dispensed through a Risk Evaluation and Mitigation Strategy program, with Onco360 handling specialty dispensing and clinical support for eligible patients as the drug enters commercial rollout for an underserved group. The launch sits within Bristol-Myers Squibb's broader push in oncology therapies, where treatment access and safety controls are central to the business model, and the company carries a US$124.9b market cap. The company's narrative frames oncology launch execution as an offset to patent cliff risk, alongside global launches and commercial expansion of newer products. The practical test for investors will be ZENBEXUS uptake once the REMS network is fully operational, including disclosures on treated patient numbers within the eligible multiple myeloma population and updates on access or prescriber adoption tied to the Onco360 dispensing model.

Bristol Myers Squibb's growth portfolio now accounts for 56% of total revenues, up from 51.8% a year earlier, after sales from those products rose 13% in the first half of 2026. The growth portfolio comprises Opdivo, Opdivo Qvantig, Orencia, Yervoy, Reblozyl, Camzyos, Breyanzi, Opdualag, Zeposia, Sotyktu, Krazati and Cobenfy, while legacy products including Eliquis, Revlimid, Pomalyst, Sprycel and Abraxane make up the remaining 44% of revenues and face loss of exclusivity and generic competition. Opdivo Qvantig, the subcutaneous formulation of Opdivo, is now generating more than $1 billion in annualized revenues, and the FDA recently granted accelerated approval to iberdomide, in combination with daratumumab and hyaluronidase-fihj and dexamethasone under the brand name Zenbexus, for adults with multiple myeloma who have received at least one prior line of therapy, making it the first FDA-approved cereblon E3 ligase modulator. The Zacks Consensus Estimate for 2026 EPS has moved north to $6.91 from $6.34 in the past 60 days, while the 2027 EPS estimate has improved to $6.46 from $6.12. Bristol Myers shares have gained 13.4% year to date compared with the industry's growth of 8.5%, and the stock trades at 9.28X forward earnings versus the large-cap pharma industry's 18.23X.

The AI Structural Biology Network, powered by Apheris, launched AISB Bind, a federated initiative in which AbbVie, AstraZeneca, Bristol Myers Squibb, and Johnson & Johnson will collaboratively train an AI model to predict how small molecules bind to protein targets for virtual screening and lead optimization. The new initiative extends the network's first effort, which focused on protein-ligand structure prediction, where a co-folding model fine-tuned across more than 20,000 proprietary structures from active drug-discovery programs raised the share of high-quality predictions from 36% to 52%, outperforming public models and any model fine-tuned on a single partner's data alone. In AISB Bind, the four founding partners contribute three complementary types of data: experimentally determined structures, quantitative affinity and potency measurements, and high-throughput screening activity data, the last adding a large body of confirmed non-binders that is rarely available at industrial scale. Training runs through federated learning, so each partner's proprietary data stays within its own secure environment, with Apheris hosting the network and running the training and each partner receiving the resulting model to run and further tailor internally. Federated training begins in September 2026, with final models expected in early 2027, powered by the infrastructure of Apheris's technology partner, Amazon Web Services.

Bristol Myers Squibb announced positive two-year results from the late-stage POETYK PsA-2 study of Sotyktu, or deucravacitinib, including its open-label extension. Among patients entering the extension, clinical responses improved from week 16 through week 52 and were sustained through week 104, with robust results across ACR20/50/70 and Minimal Disease Activity in both continuous Sotyktu patients and those who switched from placebo at week 16. The safety profile remained consistent through week 104 with no new safety signals; adverse events occurred in 86.6% of 604 patients exposed to Sotyktu, while serious adverse events and discontinuations due to adverse events were reported in 12.6% and 7.6% of patients, respectively. Sotyktu, an oral selective tyrosine kinase 2 inhibitor approved in the United States and numerous other countries for moderate-to-severe plaque psoriasis and active psoriatic arthritis, generated $156 million in first-half 2026 revenues, up 24% year over year. Data from the POETYK SLE-1 and SLE-2 studies in systemic lupus erythematosus are expected later in 2026, while Amgen's Otezla and Takeda's investigational zasocitinib, whose new drug application the FDA recently accepted for plaque psoriasis, remain competitive threats.

Pfizer's decade-long streak of annual dividend increases has stalled, with its quarterly payout holding at $0.43 through the September 1, 2026 payment after the January 2026 ex-dividend date matched the prior four quarters instead of rising. The 6.20% yield remains covered by reaffirmed 2026 adjusted diluted EPS guidance of $2.80 to $3.00 against a run-rate $1.72 annual payout, and Q1 2026 adjusted EPS of $0.75 beat consensus for a fifth consecutive quarter above estimates. Cash outflow is real, with $2.4 billion in dividends paid in Q1 alone and $9.8 billion for full-year 2025, while Pfizer completed no buybacks in 2025 and anticipates none in 2026 despite $3.3 billion of unused authorization. On the August 4, 2026 call, incoming interim CFO Cecile Guegan said Pfizer would keep maintaining and over the long term growing the dividend, and Chairman and CEO Albert Bourla said the dividend will be maintained and eventually start growing again after the loss-of-exclusivity period. Peers have not frozen their payouts: Merck raised its quarterly from $0.81 to $0.85 starting with the December 2025 ex-date, and Bristol-Myers Squibb nudged its payout from $0.62 to $0.63 with the January 2026 ex-date. The pressure behind the pause is visible in the mix, with Comirnaty down 59% and Paxlovid down 62% in Q1 2026 and roughly $1.5 billion in additional generic and biosimilar headwind guided for the year, partly offset by launched and acquired products growing 22% operationally and Vyndamax exclusivity now running to June 2031.

Supernus Pharmaceuticals reported second-quarter revenues of $211.3 million, up 27.7% year on year and exceeding analysts' expectations by 2.8%, as the broader group of 9 branded pharmaceuticals stocks tracked reported a strong quarter with revenues beating consensus estimates by 6.6% as a group. The company said full-year operating income guidance exceeded analysts' expectations and full-year revenue guidance slightly topped them, prompting President and CEO Jack Khattar to cite the continued strength and sustained momentum of its growth products and continued execution on its commercial strategy. Despite the beat, Supernus shares are down 5.9% since reporting and currently trade at $41.99. Among peers, Bristol-Myers Squibb reported revenues of $12.97 billion, up 5.7% year on year and 12.9% above expectations, while Corcept Therapeutics posted revenues of $256.1 million, up 31.7% and 21.6% above estimates, the biggest beat and highest full-year guidance raise of the group. Zoetis delivered the weakest performance, with revenues of $2.47 billion, flat year on year and 1.5% below expectations, alongside a significant miss of full-year EPS guidance estimates.

Bristol-Myers Squibb reported positive two-year Sotyktu results in psoriatic arthritis and affirmed a quarterly dividend of US$0.63 per share for November payment. The clinical and income news arrives as the company's share price has climbed 16.37% over the past 90 days and 17.55% year to date, with a 1-year total shareholder return of 44.42%. Bristol-Myers Squibb last closed at $62.84, while the most followed narrative pegs fair value at $66.21, a small valuation gap the market has not fully closed. The company's pipeline and life-cycle management for major brands, plus strategic partnerships with BioNTech, Philochem and Bain, are seen as offsetting upcoming patent expiries, though heavy dependence on drugs facing those expiries and increasing drug pricing pressure remain key risks.

Arm Holdings CEO Rene Haas said artificial intelligence could help find a cure for cancer within our lifetime, but warned that chip shortages are limiting the expansion of AI infrastructure. In an interview with the BBC, Haas said AI could eventually solve complex problems in cancer research and accelerate drug development, though modelling cells and DNA markers remains too complex today. The computing requirements for AI-driven drug discovery are already substantial, with Generate Biomedicines co-founder Gevorg Grigoryan noting that large-scale model training needs access to many GPUs, plus proprietary biological data. Bristol Myers Squibb has deployed a new NVIDIA AI computing system to support research across cancer and other therapeutic areas. Haas described the industry as in an "absolutely supply-constrained environment," saying more chip factories are needed to support growing data centers, but manufacturing capacity cannot be added overnight. He also said Arm's power-efficient technology is used in about half of AI data centers worldwide, and demand for Arm's AGI chip, developed with Meta Platforms, has exceeded $2 billion since its launch.

Bristol Myers Squibb announced positive topline results from the registrational Phase 2 QUINTESSENTIAL trial of arlocabtagene autoleucel, a potential first-in-class GPRC5D-directed CAR T cell therapy, in patients with quadruple-class exposed relapsed and refractory multiple myeloma. The trial met its primary endpoint of overall response rate and key secondary endpoint of complete response rate in this heavily pretreated population who had received prior BCMA-targeted therapy. QUINTESSENTIAL is the first pivotal trial to evaluate a therapy in quadruple-class exposed patients following prior BCMA-targeted therapies, and arlo-cel is designed as a single infusion. The safety profile was consistent with other CAR T cell therapies. Full results will be presented at an upcoming medical meeting.

Bristol Myers Squibb presented results from the EXPLORER-LTE cohort of the MAVA-LTE study at the European Society of Cardiology Congress 2026, showing that Camzyos (mavacamten) provides sustained efficacy and safety for up to five years in patients with symptomatic obstructive hypertrophic cardiomyopathy. The single-arm, open-label extension of the Phase 3 EXPLORER-HCM study included 231 patients, with 97.4% achieving a Valsalva left ventricular outflow tract gradient of 30 mm Hg or less, 69.6% improving by at least one New York Heart Association class, and 59.2% becoming asymptomatic at 252 weeks. Mean resting and Valsalva LVOT gradients decreased by 38.7 mm Hg and 55.6 mm Hg, respectively, while left ventricular ejection fraction decreased by 10.2% but remained within normal range. Additional real-world data from the COLLIGO-HCM study and a German registry reinforced the drug's effectiveness across diverse populations, and a Swedish healthcare resource utilization study highlighted the disease burden of HCM. No new safety signals emerged, and the findings support Camzyos as the most-studied cardiac myosin inhibitor, with over 25,000 patients treated in the U.S. alone.

The U.S. FDA has approved Bristol-Myers Squibb's oral blood-cancer drug iberdomide, sold as Zenbexus, for patients with relapsed or refractory multiple myeloma, given with Johnson & Johnson's Darzalex and dexamethasone. The approval adds a potential growth driver to BMY's oncology portfolio, supported by late-stage data showing improved minimal residual disease rates versus standard therapy. Zenbexus has a list price of $29,500 for a 28-day cycle, and about 36,000 new U.S. cases are expected this year. However, the drug received accelerated approval, requiring confirmatory trials, and carries a boxed warning for embryo-fetal toxicity, distributed through a restricted program. Competition in multiple myeloma remains intense, so Zenbexus may build into a growth driver over time rather than an immediate game changer.

Bristol-Myers Squibb announced on August 10 that it will invest about $2.3 billion in a new manufacturing plant in Houston, part of a larger $40 billion U.S. investment pledge. The roughly 600,000-square-foot campus will produce small-molecule medicines, biologics, and antibody-drug conjugates, and is expected to create close to 500 skilled jobs and about 2,000 construction jobs between 2027 and 2030. Texas is providing $4.89 million in state funding for the project. The move comes as drugmakers including Eli Lilly, Johnson & Johnson, and Pfizer expand U.S. manufacturing amid tariff pressure from the Trump administration. Separately, British regulators cleared Eli Lilly's weight-loss pill Foundayo for weight management and type 2 diabetes, making the UK the first country in Europe to approve the drug.

Bristol Myers Squibb raised its full-year 2026 revenue guidance to $49-$50 billion, up from $46-$47.5 billion, after Eliquis sales grew 19% to $8.6 billion in the first half. The company now expects Eliquis revenue growth of 20-25% for the year, versus a prior 10-15% forecast, and legacy portfolio revenues to decline 4-6% instead of 12-16%. Eliquis, co-commercialized with Pfizer, posted 22% growth in the second quarter, helping offset generic erosion for Revlimid, Pomalyst, Sprycel and Abraxane. Management still expects Eliquis sales to decline by $1.5-$2 billion in 2027.

Bristol Myers Squibb announced a new collaboration with Chai Discovery to advance AI-driven therapeutic antibody discovery. The agreement focuses on using artificial intelligence and machine learning to support the identification of novel therapeutic antibody candidates. The move reflects Bristol Myers Squibb's effort to integrate advanced computational tools into its drug discovery work. Investors should watch for pipeline updates where the company attributes new antibody programs or faster candidate selection to this AI system.

Corcept Therapeutics reported second-quarter revenues of $256.1 million, up 31.7% year on year and beating analysts' expectations by 21.6%, making it the standout performer among eight branded pharmaceutical stocks tracked. The company also beat EPS estimates and raised full-year revenue guidance above expectations, with its stock up 28.1% since reporting to trade at $119.05. Bristol-Myers Squibb posted revenues of $12.97 billion, up 5.7% and 12.9% above estimates, while Eli Lilly delivered the fastest revenue growth at 47.7% to $22.97 billion, beating by 11.4%. Zoetis was the weakest, with flat revenues of $2.47 billion missing estimates by 1.5% and lowering full-year guidance. Supernus Pharmaceuticals reported $211.3 million in revenue, up 27.7% and 2.8% above estimates.

Healthcare ETFs are hitting one-year highs as the sector benefits from improving earnings visibility, attractive relative valuations, and a rotation out of overcrowded AI and tech trades into defensive growth. State Street Health Care Select Sector SPDR ETF XLV has surged 6.6% over the past month compared with 3.4% gains for State Street SPDR S&P 500 ETF Trust SPY. S&P 500 healthcare companies are expected to deliver double-digit earnings growth from Q4 2026 through 2027, and the sector is expected to log a 21.2% increase in earnings on 2.2% higher revenues, according to Zacks Sector and Market Earnings Trends issued on Aug. 12, 2026. M&A value in the sector has touched nearly $284 billion this year, approaching 2025's total of $306 billion, and hedge fund bets in favor of healthcare stocks recently neared a five-year high, per a Goldman Sachs note. The FDA has accelerated its approval process, with the annual number of new drug approvals in 2025 reaching its highest level since 2020.

Hematogenix announced that its proprietary Next Generation Flow Cytometry assay for multiple myeloma minimal residual disease served as the analytical method for the pivotal efficacy endpoint supporting the FDA's accelerated approval of Bristol Myers Squibb's ZENBEXUS (iberdomide), the first CELMoD therapy approved for multiple myeloma. The FDA-approved prescribing information states that MRD-negative complete response was assessed using a Hematogenix Next Generation Flow Cytometry assay at a threshold of 10⁻⁵. In the Phase 3 EXCALIBER-RRMM trial, patients treated with ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone achieved an MRD-negative complete response rate of 41%, compared with 21% for patients treated with daratumumab, bortezomib, and dexamethasone, a statistically significant improvement with p<0.0001. Hematogenix President and CEO Dr. Hytham Al-Masri said being named directly in the FDA label for the first approved therapy in a novel drug class validates the precision and scientific rigor of the company's laboratory platform. Hematogenix operates CAP-accredited and CLIA certified laboratories in the United States, United Kingdom, Malaysia, and China.

China has pulled ahead of the United States in clinical drug development and supply chain, two of six domains measured in a June Cure Innovation Index survey, even as Big Pharma signs billion-dollar deals for Chinese-developed medicines. Dr. Nathan Goodyear of Williams Cancer Institute told Benzinga that roughly a third of new drugs Big Pharma licensed in came from Chinese labs, up from almost none a decade ago. Bristol Myers Squibb signed a $15.2 billion collaboration with Jiangsu Hengrui Pharmaceuticals in May covering 13 early-stage programs, while Merck reached a $2 billion licensing agreement in March 2025 for HRS-5346, a cardiovascular drug developed entirely in China. The U.S. Department of Health and Human Services launched Operation TrailBlazer in late June, and Congress introduced the Biotech Investment National Security Act to screen outbound biotech investment, building on the Biosecure Act signed into law in December 2025. The survey of 117 senior U.S. industry and academic leaders found 76% say the U.S. leads but China is closing fast, 85% say the U.S. lead lasts 10 years or less, and 72% agree China is improving faster than the U.S.

Bristol Myers Squibb received FDA accelerated approval for ZENBEXUS in a multiple myeloma combination regimen, marking the first approved CELMoD therapy in this disease setting. The approval comes as the stock trades at $64.65, with a 30-day return of 13.52%, a year-to-date return of 20.93%, and a one-year total shareholder return of 41.71%. Analysts following the most popular narrative value the stock at $62.96, about 3% below the current price, citing declining revenue but rising margins and a higher future P/E. The company's current P/E of 14.2x is below the US Pharmaceuticals industry average of 16.6x.

The U.S. Food and Drug Administration has granted accelerated approval to Bristol Myers Squibb's ZENBEXUS, the first CELMoD therapy, in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Approval was based on Phase 3 EXCALIBER-RRMM results showing the ZDd regimen doubled minimal residual disease-negative complete response rates versus daratumumab, bortezomib and dexamethasone, at 41% versus 21%. ZENBEXUS carries Boxed Warnings for embryo-fetal toxicity and venous and arterial thromboembolism, and is available only through a restricted REMS program. Bristol Myers Squibb also noted that a New Drug Application for mezigdomide, another investigational CELMoD, is under FDA review with a target date of May 13, 2027.

Atrium Therapeutics reported second quarter 2026 financial results and announced FDA clearance of its IND application for ATR 1072, enabling the launch of the Corventis Phase 1/2 trial in PRKAG2 syndrome. The company also earned a second milestone payment of $15 million under its global cardiovascular collaboration with Bristol Myers Squibb, which will be recorded in the third quarter. Collaboration revenue was $3.0 million for the quarter, while R&D expenses were $15.3 million and G&A expenses were $10.3 million. As of June 30, 2026, Atrium had $263.9 million in cash, cash equivalents and short-term investments, which the company believes is sufficient to fund operations through mid-2028. The Corventis trial is expected to enroll its first participant by the end of 2026, with initial proof-of-concept data anticipated in the second half of 2027.

Bristol Myers Squibb's growth portfolio sales rose 13% in the first half of 2026, lifting its share of total revenues to 56% from 51.8% a year earlier. The portfolio includes Opdivo, Opdivo Qvantig, Orencia, Yervoy, Reblozyl, Camzyos, Breyanzi, Opdualag, Zeposia, Sotyku, Krazati and Cobenfy. Opdivo Qvantig is now generating annualized revenues of more than $1 billion. Legacy products including Eliquis, Revlimid, Pomalyst, Sprycel and Abraxane still account for 44% of revenues and face erosion from loss of exclusivity. Bristol Myers shares have gained 17.9% year to date, and the Zacks Consensus Estimate for 2026 EPS has risen to $6.81 from $6.32 over the past 60 days.

AstraZeneca shares suffered their biggest one-day drop since 2020, closing down as much as 9%, after reports emerged that the company held merger talks with U.S. rival Bristol-Myers Squibb. A combined entity would be worth close to $400 billion, making it the fourth-largest drugmaker globally by market value, though neither firm confirmed the discussions and people familiar with the matter told Reuters a deal may never materialize. Investors and analysts reacted with skepticism, with Jefferies analysts saying they were "a bit perplexed" given AstraZeneca's strong growth trajectory under CEO Pascal Soriot, who recently reiterated the company does not need M&A to reach its $80 billion annual revenue target by 2030. Union Investment's Markus Manns called the idea strategically and financially unsound, while ATG Healthcare's Lukas Leu described it as growth-dilutive in the near term. Bristol-Myers Squibb shares initially rose as much as 6% on the news, reflecting a view that the company needs a deal more urgently as its top products Eliquis and Opdivo face looming patent expirations, though BMO's Evan Seigerman warned that antitrust concerns over overlapping cancer drugs could reduce the odds of a successful merger.