Bristol Myers Squibb Co【BMY】株式ニュース

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U.S. Food and Drug Administration Approves Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection, for Subcutaneous Use in Most Previously Approved Adult, Solid Tumor Opdivo® (nivolumab) Indications1,2

Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor1 Given over three- to...

Bristol Myers Squibb Announces Positive Topline Results from Two Pivotal Phase 3 Trials Evaluating Sotyktu (deucravacitinib) in Adults with Psoriatic Arthritis

POETYK PsA-1 and POETYK PsA-2 trials met primary endpoint, with significantly greater proportion of Sotyktu-treated patients achieving ACR20...

Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite Instability–High or Mismatch Repair Deficient Metastatic Colorectal Cancer

Approval based on results of the Phase 3 CheckMate -8HW trial, in which the dual immunotherapy combination of Opdivo plus Yervoy demonstrated...

Bristol Myers Squibb to Report Results for Fourth Quarter 2024 on February 6, 2025

Bristol Myers Squibb (NYSE: BMY) will announce results for the fourth quarter of 2024 on Thursday, February 6, 2025. Company executives will...

Bristol Myers Squibb Announces Dividend Increase

Bristol Myers Squibb (NYSE: BMY) today announced that its Board of Directors has declared a quarterly dividend of sixty-two cents ($0.62) per...

Bristol Myers Squibb Highlights Progress of Cell Therapy Portfolio at ASH 2024 with Long-Term Survival Data and Results from Expanding Pipeline

Data presentations highlight BMS’ leadership and commitment to harnessing the full potential of cell therapy, with advances in blood cancers and...

Bristol Myers Squibb to Participate in Citi’s 2024 Global Healthcare Conference

Bristol Myers Squibb (NYSE: BMY) today announced that the company will participate in Citi’s 2024 Global Healthcare Conference. Christopher...

Bristol Myers Squibb’s Presentations at ASH 2024 Reinforce Strength of Hematology Portfolio and Scientific Advances in Differentiated Research Platforms

Data from more than 20 programs, including new research from cell therapy and targeted protein degradation platforms, showcase the depth and...

Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite Instability–High or Mismatch Repair Deficient Metastatic Colorectal Cancer

Opinion based on results from the Phase 3 CheckMate -8HW trial, in which the dual immunotherapy combination of Opdivo and Yervoy demonstrated...

Bristol Myers Squibb Receives Positive CHMP Opinion for Repotrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer and Advanced NTRK-Positive Solid Tumors

Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity with...

Perspective Therapeutics Provides Recent Business Highlights and Reports Fiscal 3Q 2024 Results

Advancing investigation of [212Pb]VMT01 as a monotherapy and in combination with the anti-PD-1 antibody...

Bristol Myers Squibb Showcases the Continued Strength of its Cardiovascular Portfolio with New Clinical and Real-World Data at American Heart Association Scientific Sessions 2024

Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence...

Form 4 - Statement of changes in beneficial ownership of securities

Schizo drug approval coming?
Deep Pipeline.
$BMY

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morokoy 3月前

Keeping an eye on this one, looking for a repeat. Bought on 7/9, sold 8/9 for a 15.96% gain.
Record date is 10/4, looking at $50.00 9/27 Options to get me in on time. Divvy is $0.60
Will see what develops.

safest buy in market right now at $39-$42

other safe bets

PFE CSCO SLB BP CAG HRL CPB

AZN pays BMY/Ono Pharma $510M to_settle_all_patent_litigation_regarding Imjudo/Imfinzi:

https://www.fiercepharma.com/pharma/bristol-myers-astrazeneca-settle-pd-1-ctla-4-cancer-immunotherapy-patent-suits-510m

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DewDiligence 1年前

BMY 2Q23 CC transcript:

https://www.fool.com/earnings/call-transcripts/2023/07/27/bristol-myers-squibb-bmy-q2-2023-earnings-call-tra

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DewDiligence 1年前

BMY reports 2Q23 results—cuts 2023 non-GAAP EPS guidance:

PR:
https://s21.q4cdn.com/104148044/files/doc_financials/quarterly_reports/2023/BMY-Q22023-Earnings-Press-Release.pdf

CC slides:
https://s21.q4cdn.com/104148044/files/doc_presentations/2023/BMY-2023-Q2-Results-Investor-Presentation-Appendix.pdf

2023 non-GAAP EPS guidance is now $7.35-7.65, down $0.60 from the prior range of $7.95-8.25. The new guidance represents a 4% YoY decline at the midpoint of the range. The reason for the cut is lower expected sales of Revlimid (now generic) and Pomalyst (soon to be generic).

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DewDiligence 1年前

Opdivo monotherapy—>statsig OS/PFS as_addend_to_cisplatin_in first-line bladder cancer:

https://finance.yahoo.com/news/opdivo-nivolumab-combination-cisplatin-based-105900450.html

The trial in question is a 600-patient sub-study of CHECKMATE-901, which is now complete. (The other part of CHECKMATE-901, which compares Opdivo/Yervoy vs chemo, is ongoing.) The trial had no requirement for PD-L1 expression.

Today’s PR does not contain a hazard ratio or any other detailed results; those data will be presented at an unspecified medical conference.

Opdivo for bladder cancer is already FDA-approved in the adjuvant (#msg-165546303) and second-line (#msg-128386168) settings. Approval in the first-line (unresectable or metastatic) setting would give Opdivo across-the-board coverage for bladder cancer.

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DewDiligence 1年前

BMY opts-in for worldwide rights_to PRTA’s anti-tau compound, PRX005:

https://www.businesswire.com/news/home/20230710599297/en

PRTA reported phase-1 data for PRX005 in Alzheimer’s disease in Jan 2023 (#msg-171085895).

BMY opted in for the US rights to PRX005 in 2021 (#msg-164573926), which resulted in an $80M milestone payment to PRTA. Today’s opt-in for the ex-US rights generates an additional $55M payment to PRTA.

This collaboration, which BMY inherited from CELG (#msg-139431013), potentially includes two drug candidates in addition to PRX005 (one targeting TDP-43 and one with an undisclosed target), but BMY has as yet opted in only for PRX005 and has shown no interest in the other two candidates, as far as I know.

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DewDiligence 2年前

GERN submits Imetelstat NDA for treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes:

https://www.businesswire.com/news/home/20230620336071/en

This is an indication where BMY is seeking FDA approval for Reblozyl and where Reblozyl is already approved in the EU.

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DewDiligence 2年前

BMY sues US government regarding IRA:

https://www.bms.com/impact-of-the-inflation-reduction-act-on-innovative-medicines-for-patients.html

The arguments are very similar to MRK’s IRA lawsuit (#msg-172068691). It seems pretty likely that these lawsuits will eventually be consolidated.

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DewDiligence 2年前

BMY’s ASCO slide set:

https://s21.q4cdn.com/104148044/files/doc_presentations/2023/bmy-asco-investor-presentation.pdf

These are the slides that accompanied BMY’s investor webcast today.

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DewDiligence 2年前

Opdivo bests Adcetris in first-line-HL PFS—immature_OS_data_trending_in_favor_of_Opdivo:

https://www.fiercepharma.com/pharma/seagens-top-selling-drug-under-threat-bristol-myers-opdivo-beats-adcetris-lymphoma Compared with Adcetris, Bristol Myers Squibb’s Opdivo significantly reduced the risk of cancer progression or death by 52% [i.e. the HR for PFS was 0.48—Dew] in adults and children with newly diagnosed stage 3 or 4 classical Hodgkin lymphoma, according to phase 3 data unveiled at the 2023 American Society of Clinical Oncology annual meeting. Both drugs were used on top of the AVD regimen of chemotherapy.

The collaborative group-conducted trial, coded SWOG S1826, randomized nearly 1,000 patients. The results point to Opdivo-AVD as “a new standard of care that is better tolerated and results in a higher proportion of patients with durable remissions” than Adcetris-AVD, Oreofe Odejide, M.D., from the Dana-Farber Cancer Institute and an invited ASCO expert, said in a statement.

…Opdivo is currently only allowed in HL following Adcetris treatment thanks to an FDA accelerated approval in 2016. The new SWOG trial will support an FDA filing for Opdivo in front-line treatment, Herrera told Fierce Pharma in an interview. It could also help Bristol Myers turn the original conditional nod into a full approval.

…The Opdivo regimen has yet to show a significant patient survival benefit. By the data cutoff, 11 (2.2%) deaths happened in the Adcetris arm, compared with four (0.8%) for Opdivo. It will take a few years for the OS data from this trial to reach maturity.

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DewDiligence 2年前

Repotrectinib NDA has 11/27/23 PDUFA date—(with FDA priority review):

https://finance.yahoo.com/news/u-food-drug-administration-accepts-105900511.html

The indication is locally advanced or metastatic ROS1-positive NSCLC.

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DewDiligence 2年前

CHMP approves Opdivo/chemo in neoadjuvant NSCLC:

https://www.businesswire.com/news/home/20230525005752/en

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DewDiligence 2年前

Milvexian—>FDA Fast Track designation for_all_indications:

https://finance.yahoo.com/news/milvexian-granted-u-fda-fast-105900364.html

The three indications BMY is pursuing in phase-3 are: secondary stroke prevention; ACS; and primary stroke prevention in patients with AF.

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DewDiligence 2年前

BMY’s BMS-986278 for IPF will advance to phase-3:

https://www.businesswire.com/news/home/20230519005266/en

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DewDiligence 2年前

IMMP +65% on interim (single-arm) phase-2 data for LAG-3 drug with Keytruda in NSCLC:

https://finance.yahoo.com/news/immutep-efti-combination-pembrolizumab-achieves-120000596.html

IMMP’s eftilagimod alpha is a LAG-3 protein that targets the same biologic pathway as BMY’s relatlimab, one of the component drugs (along with Opdivo) in Opdulag.

BMY’s Opdulag, which was FDA approved in Mar 2022 for first-line melanoma, is already selling at an annualized rate of $500M in the US alone (#msg-171784010).

Please see #msg-168259768 for related info.

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DewDiligence 2年前

BMY’s ASCO/EHA/ICML lineup:

https://www.businesswire.com/news/home/20230510006079/en

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DewDiligence 2年前

$3.4M insider sale yesterday by BMY’s CSO, Rupert Vessey:

https://www.sec.gov/Archives/edgar/data/14272/000001427223000114/xslF345X04/wf-form4_168323704827586.xml

Unless Vessey is buying a house, a sale of this size at this price level is somewhat concerning.

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DewDiligence 2年前

BMY 1Q23 CC transcript:

https://finance.yahoo.com/news/q1-2023-bristol-myers-squibb-042637576.html

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DewDiligence 2年前

BMY 1Q23 results…

PR:
https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-Reports-First-Quarter-Financial-Results-for-2023/default.aspx

CC slides:
https://s21.q4cdn.com/104148044/files/doc_presentations/2023/BMY-2023-Q1-Results-Presentation-Appendix.pdf

2023 non-GAAP EPS guidance remains $7.95-8.25, +4% YoY at the midpoint of the range.

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DewDiligence 2年前

BMY’s CCO, Christopher Boerner—>CEO effective 11/1/23:

https://www.sec.gov/ix?doc=/Archives/edgar/data/0000014272/000114036123020605/brhc20052030_8k.htm

CEO, Giovanni Caforio will become Executive Chairman on 11/1/23. Between now and 11/1/23, Boerner will have the title of COO.

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DewDiligence 2年前

CHMP approves Camzyos:

https://finance.yahoo.com/news/bristol-myers-squibb-receives-positive-184200509.html

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DewDiligence 2年前

CHMP approves Breyanzi in second-line LBCL:

https://www.businesswire.com/news/home/20230330005697/en

FDA approval in this indication came in Jun 2022 (#msg-169240243).

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DewDiligence 2年前

BMY, EVO extend/expand neurodegeneration collaboration:

https://www.accesswire.com/viewarticle.aspx?id=746175&lang=en

The collaboration now runs for another eight years, and EVO receives an additional $50M in up-front cash.

Note that BMY and EVO are also collaborating in protein degradation (#msg-168811996).

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DewDiligence 2年前

EC approves Sotyktu for psoriasis:

https://finance.yahoo.com/news/bristol-myers-squibb-receives-european-105900011.html

Essentially same label as FDA’s.

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DewDiligence 2年前

TAK-279 vs Sotyktu (from biopharmadive.com): #msg-171480207.

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DewDiligence 2年前

BMY will not launch Opdualag in Germany due to pricing constraints on FDC (combination) drugs:

https://endpts.com/bristol-myers-axes-german-launch-of-new-cancer-drug-citing-pricing-hurdles/

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DewDiligence 2年前

BMY/JNJ unveil_phase-3_program_for Milvexian—50,000 patients_across_three_ trials_in secondary stoke prevention, ACS, and AF/primary stroke prevention:

https://www.businesswire.com/news/home/20230228006466/en Enrollment has begun for the Librexia STROKE trial, which is evaluating milvexian in addition to standard of care antiplatelet therapy for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack. The Librexia ACS trial, which will evaluate event reduction in acute coronary syndromes in addition to standard of care antiplatelet therapy, and the Librexia AF trial, which will investigate milvexian compared to apixaban [Eliquis] in the prevention of stroke in patients with atrial fibrillation, will also initiate during the first half of 2023. Milvexian is an oral FXIa inhibitor. The phase-3 trial in secondary stroke prevention is at: https://www.clinicaltrials.gov/ct2/show/NCT05702034 .

The commercial impetus for the Milvexian program is to supersede Eliquis (BMY) and Xarelto (JNJ) when those drugs go off-patent or become subject to Medicare price-setting. The competition for Milvexian is Bayer’s Asundexian, another oral FXIa inhibitor that started a somewhat less aggressive phase-3 program (#msg-169841711) that does not have a trial for ACS.

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DewDiligence 2年前

Opdivo PDUFA date for adjuvant melanoma—>10/13/23:

https://finance.yahoo.com/news/u-food-drug-administration-accepts-115900042.html

The corresponding MAA has been validated by the EMA, starting the review clock.

The sBLA and MAA are based on the CHECKMATE-076 study, which showed HR=0.42 for the primary RFS endpoint (#msg-170239823).

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DewDiligence 2年前

BMY’s ACC lineup:

https://www.businesswire.com/news/home/20230224005299/en

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DewDiligence 2年前

BMY/TVST report Abecma data from phase-3 KarMMa-3 study:

https://www.businesswire.com/news/home/20230209005647/en At a median follow up of 18.6 months, treatment with Abecma (n=254) demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared with standard regimens (n=132), with a median PFS of 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9), respectively (HR:0.49; p<0.0001).Abecnma is currently FDA-approved for fifth-line MM; the results above should enable a label expansion into the third-line setting.

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DewDiligence 2年前

BMY -2.5% today—possible reason is that the CEO just sold $18M worth of stock—approximately half his holding—(the Form-4 filing hit the wires last night after the close):

https://www.sec.gov/Archives/edgar/data/14272/000001427223000044/xslF345X03/wf-form4_167590496019590.xml

It's hard to interpret a transaction of this size as non-bearish. I wonder if Giovanni Caforio is planning to retire in the next 12-18 months.

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DewDiligence 2年前

Bayer enrolls first phase-3 patients for FXIa inhibitor, Asundexian:

https://www.businesswire.com/news/home/20230208005322/en
• The OCEANIC program will investigate the efficacy and safety of asundexian (BAY2433334) in the prevention of stroke in patients with atrial fibrillation and also patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA)
2
• OCEANIC-AF and OCEANIC-STROKE are expected to enroll more than 27,000 patients in over 40 countries Bayer’s competition in this arena is BMY/JNJ’s Milvexian (#msg-169818942, #msg-169841711), which is awaiting the start of phase-3.

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DewDiligence 2年前

BMY 4Q22 CC transcript:

https://www.fool.com/earnings/call-transcripts/2023/02/02/bristol-myers-squibb-bmy-q4-2022-earnings-call-tra/

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DewDiligence 2年前

BMY’s Sotyktu patients are coming approximately 1/3 from treatment-naïve, 1/3 for Otezla switches, and 1/3 from biologic switches. (Source: 4Q22 CC.)

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DewDiligence 2年前

BMY 4Q22 CC slides:

https://s21.q4cdn.com/104148044/files/doc_presentations/2022/BMY-Q4-2022-Results-Presentation-with-Appendix.pdf

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DewDiligence 2年前

BMY 4Q22 results—2023 guidance:

https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-Reports-Fourth-Quarter-and-Full-Year-Financial-Results-for-2022/default.aspx

2023 non-GAAP EPS guidance is $7.95-8.25; at the midpoint of the range, this is a 4% increase relative to 2022’s non-GAAP EPS of $7.70.

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DewDiligence 2年前

CHMP approves BMY’s Sotyktu for psoriasis:

https://www.businesswire.com/news/home/20230125005858/en

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DewDiligence 2年前

Addendum—Breyanzi is the first CAR-T to show efficacy in CLL, as far as I know. rrCLL is a large market; if Breyanzi’s complete-response rate after, say, 5 years is as high as 15-20%, this indication could be a meaningful commercial contributor.

Breyanzi, which is currently approved for various forms of relapsed NHL, has annualized sales of under $200M.

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DewDiligence 2年前

BMY’s Breyanzi meets primary endpoint in rrCLL/SLL single-arm trial:

https://finance.yahoo.com/news/bristol-myers-squibb-announces-transcend-115900140.html Bristol Myers Squibb today announced topline results from TRANSCEND CLL 004, a Phase 1/2, open-label, single-arm, multicenter study evaluating Breyanzi (lisocabtagene maraleucel) in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Results from TRANSCEND CLL 004 showed the study met the primary endpoint of complete response rate compared to historical control in the prespecified subset of patients with R/R CLL that was refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor. The trial listing is at:
https://www.clinicaltrials.gov/ct2/show/NCT03331198

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DewDiligence 2年前

BMY’s JPM webcast slides:

https://www.sec.gov/Archives/edgar/data/14272/000114036123000970/brhc10046308_99-1.htm

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DewDiligence 2年前

BMY’s Breyanzi continues to show robust results in second-line LBCL after longer follow-up:

https://www.fiercepharma.com/pharma/bristol-myers-bolsters-breyanzis-earlier-lymphoma-case-elevated-car-t-fight-against-gilead-0

Data from the same trial presented one year ago (at ASH 2021) are in #msg-164317285.

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DewDiligence 2年前

BMY’s ASH presentations:

https://finance.yahoo.com/news/bristol-myers-squibb-announces-first-115900939.html

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DewDiligence 2年前

BMY boosts annualized dividend to $2.28—(from $2.16):

https://finance.yahoo.com/news/bristol-myers-squibb-announces-dividend-211600245.html

At the current share price ($79.88), the new annualized payout is a yield of 2.9%.

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