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      6. Bristol Myers Squibb Co (BMY)

      7. Bristol Myers Squibb Co (BMY) News

      Bristol Myers Squibb Co

      Bristol Myers Squibb Co (BMY)

      Bloomsbury Publishing Plc
      59.22
      -0.05
      (-0.08%)
      At close: December 01 4:00PM
      Delayed by 15 minutes
      59.22
      0.00
      ( 0.00% )
      After Hours: 5:04PM
      Delayed by 15 minutes

      Your Hub for Real-Time streaming quotes, Ideas and Live Discussions

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      BMY News

      Official News Only

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      November 05 2024
      BMY (-0.08%)

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      November 05 2024
      BMY (-0.08%)

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      November 05 2024
      BMY (-0.08%)

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      November 05 2024
      BMY (-0.08%)

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      November 05 2024
      BMY (-0.08%)

      BMY Discussion

      View Posts
      Monksdream Monksdream 1 month ago
      BMY, new 52=high
      👍️0
      TechandBio TechandBio 2 months ago
      Schizo drug approval coming?
      Deep Pipeline.
      $BMY
      👍️0
      morokoy morokoy 3 months ago
      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.
      👍️0
      Monksdream Monksdream 3 months ago
      BMY range bound
      👍️0
      Nebuchadnezzar Nebuchadnezzar 4 months ago
      easy mOnAAy BMY
      👍️0
      Nebuchadnezzar Nebuchadnezzar 4 months ago
      safest buy in market right now at $39-$42

      other safe bets

      PFE CSCO SLB BP CAG HRL CPB
      👍️0
      Sirpeter Sirpeter 5 months ago
      Boom
      👍️0
      Money hunt Money hunt 5 months ago
      RNAZ Buyout coming….
      👍️0
      DewDiligence DewDiligence 1 year ago
      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
      👍️0
      DewDiligence DewDiligence 1 year ago
      BMY 2Q23 CC transcript:

      https://www.fool.com/earnings/call-transcripts/2023/07/27/bristol-myers-squibb-bmy-q2-2023-earnings-call-tra
      👍️0
      DewDiligence DewDiligence 1 year ago
      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).
      👍️0
      DewDiligence DewDiligence 1 year ago
      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.
      👍️0
      DewDiligence DewDiligence 1 year ago
      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.
      👍️0
      DewDiligence DewDiligence 1 year ago
      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.
      👍️0
      DewDiligence DewDiligence 1 year ago
      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.
      👍️0
      DewDiligence DewDiligence 1 year ago
      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.
      👍️0
      DewDiligence DewDiligence 1 year ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      CHMP approves Opdivo/chemo in neoadjuvant NSCLC:

      https://www.businesswire.com/news/home/20230525005752/en
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      BMY’s BMS-986278 for IPF will advance to phase-3:

      https://www.businesswire.com/news/home/20230519005266/en
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      BMY’s ASCO/EHA/ICML lineup:

      https://www.businesswire.com/news/home/20230510006079/en
      👍️0
      DewDiligence DewDiligence 2 years ago
      $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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      BMY 1Q23 CC transcript:

      https://finance.yahoo.com/news/q1-2023-bristol-myers-squibb-042637576.html
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      CHMP approves Camzyos:

      https://finance.yahoo.com/news/bristol-myers-squibb-receives-positive-184200509.html
      👍️0
      DewDiligence DewDiligence 2 years ago
      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).
      👍️0
      DewDiligence DewDiligence 2 years ago
      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).
      👍️0
      DewDiligence DewDiligence 2 years ago
      EC approves Sotyktu for psoriasis:

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

      Essentially same label as FDA’s.
      👍️0
      DewDiligence DewDiligence 2 years ago
      TAK-279 vs Sotyktu (from biopharmadive.com): #msg-171480207.
      👍️0
      DewDiligence DewDiligence 2 years ago
      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/
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      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).
      👍️0
      DewDiligence DewDiligence 2 years ago
      BMY’s ACC lineup:

      https://www.businesswire.com/news/home/20230224005299/en
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      BMY 4Q22 CC transcript:

      https://www.fool.com/earnings/call-transcripts/2023/02/02/bristol-myers-squibb-bmy-q4-2022-earnings-call-tra/
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.)
      👍️0
      DewDiligence DewDiligence 2 years ago
      BMY 4Q22 CC slides:

      https://s21.q4cdn.com/104148044/files/doc_presentations/2022/BMY-Q4-2022-Results-Presentation-with-Appendix.pdf
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      CHMP approves BMY’s Sotyktu for psoriasis:

      https://www.businesswire.com/news/home/20230125005858/en
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      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
      👍️0
      DewDiligence DewDiligence 2 years ago
      BMY’s JPM webcast slides:

      https://www.sec.gov/Archives/edgar/data/14272/000114036123000970/brhc10046308_99-1.htm
      👍️0
      DewDiligence DewDiligence 2 years ago
      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.
      👍️0
      DewDiligence DewDiligence 2 years ago
      BMY’s ASH presentations:

      https://finance.yahoo.com/news/bristol-myers-squibb-announces-first-115900939.html
      👍️0
      DewDiligence DewDiligence 2 years ago
      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%.
      👍️0

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