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BMY のニュース
BMY のイベント
RBC Analyst Calls Bristol Myers Drug Results Positive
After Bristol Myers announced positive topline results from both the Phase 3 ALOFT-IPF trial for admilparant in IPF and the ACTION-1 trial for RYZ101 in GEP-NETs, RBC Capital analyst Trung Huynh called admilparant "the more significant of the two readouts." The pivotal ALOFT-IPF trial evaluating admilparant in adults with idiopathic pulmonary fibrosis met the primary endpoint at the 60mg dose, while missing at the 120mg dose, which the firm calls "encouraging, but confounding." The firm believes the 120mg dose was introduced to differentiate from competitors, but now that "this option is off the table, we think meaningful differentiation based on efficacy is unlikely," says the analyst, who has a Sector Perform rating and $64 price target on Bristol shares.
S&P 500 Futures Mixed as Oil Prices Rise
Stock futures are mixed as investors weigh rising oil prices and geopolitical risks against expectations for another strong corporate earnings season. Brent crude has climbed above $106 a barrel, reaching a roughly two-week high, after deadly strikes on Riyadh's international airport over the weekend, while uncertainty surrounding the conflict involving Iran continues to cloud the outlook for global energy supplies.The focus now shifts to third-quarter earnings, with JPMorgan Chase, Wells Fargo, Goldman Sachs and Citigroup set to report Tuesday. Analysts are expecting strong year-over-year earnings growth for S&P 500 companies, with AI-related spending and growth continuing to support the outlook. Investors are also watching September inflation figures, with CPI due Wednesday and PPI and retail sales scheduled for Thursday.Spot gold is around $4,200 an ounce and silver is near $61, as investors monitor inflation risks, interest-rate expectations and geopolitical uncertainty. The Treasury market is closed for Columbus Day, limiting fresh signals from bond trading.In pre-market trading, S&P 500 futures rose 0.05%, Nasdaq futures fell 0.16% and Dow futures rose 0.09%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -First Solarup 8% after Truist upgraded shares to Buy with a price target of $270, up from $229.Enovixup 8% after reporting preliminary Q3 resultsSalesforceup 4% after BofA upgraded the stock to Buy from Underperform with a price target of $285, up from $160Biogenup 4% after JPMorgan upgraded the stock to Overweight with a price target of $300, up from $210Bristol Myersup 3% after reporting its Phase 3 ALOFT-IPF trial evaluating the efficacy, safety and tolerability of admilparan met the primary endpointASE Technologyup 3% after reporting third quarter and monthly revenue figuresLOWER -IonQdown 3% after entering into a definitive agreement to acquire Elisity in an all-stock transaction valued at up to $1.3BAdobedown 3% after Wells Fargo double downgraded shares to Underweight from Equal Weight with a price target of $225, down from $270
Bristol Myers Squibb Announces Phase 3 Trial Results for Admilparant
Bristol Myers Squibb announced topline results from the pivotal Phase 3 ALOFT-IPF trial evaluating the efficacy, safety and tolerability of admilparant, a potential first-in-class, orally administered, potent and selective lysophosphatidic acid receptor 1 antagonist, in adults with idiopathic pulmonary fibrosis. The trial evaluated two dose levels of admilparant, 60 mg and 120 mg, twice daily for greater than or equal to52 weeks against placebo. The trial met its primary endpoint at the 60 mg dose, with admilparant demonstrating a statistically significant improvement compared to placebo in absolute change in forced vital capacity from baseline at Week 52. At the 120 mg dose, admilparant slowed the decline of FVC but was not statistically significant. Notably, admilparant demonstrated a well-tolerated safety profile across both doses in the ALOFT-IPF trial. In both admilparant arms of the trial, discontinuations due to adverse events were low and similar to placebo. "Taken together, these topline data reinforce the profile of admilparant as a promising, clinically meaningful investigational therapy for IPF - one that reflects the innovation of targeting the LPA1 pathway as a first-in-class approach," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We also look forward to sharing the topline results from the ALOFT-PPF trial early next year, as we continue working to improve outcomes for patients with pulmonary fibrosis."
Bristol Myers Squibb Announces Positive ACTION-1 Trial Results
Bristol Myers Squibb announced positive topline results from the planned interim analysis of the ACTION-1 trial conducted by RayzeBio, a Bristol Myers Squibb company. The study met the primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival by blinded independent central review, and safety results consistent with the known RYZ101 safety profile. ACTION-1 is a randomized Phase 3 clinical trial evaluating RYZ101 versus investigator's choice of standard of care in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors who have progressed following Lutetium-177-based therapy. The FDA granted RYZ101 Orphan Drug Designation for the treatment of GEP-NETs in August 2026 based on the significant unmet need facing patients with this disease. That designation, combined with the results of this interim analysis, supports RayzeBio's continued development efforts and plans to engage with the FDA to discuss next steps toward a regulatory submission. Detailed results are expected to be presented at a future medical meeting
Bristol Myers Announces Positive Phase 3 Results for Zenbexus
Bristol Myers announced positive topline results from the Phase 3 EXCALIBER-RRMM study, evaluating zenbexus - iberdomide - in combination with daratumumab and dexamethasone - ZDd - in 800 patients with multiple myeloma, or MM, as early as first relapse. Results showed ZDd demonstrated a statistically significant improvement in the dual-primary endpoint of progression-free survival, with median PFS of 42 months for ZDd vs. 20 months for daratumumab, bortezomib and dexamethasone, representing a 51% reduction in the risk of disease progression or death. Median follow-up was 23 months. The safety profile of zenbexus in combination with standard therapies remained consistent with previously reported safety findings from the study. Detailed minimal residual disease results were presented at the International Myeloma Society 23rd annual meeting and simultaneously published in Lancet Oncology.
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