[DewDiligence]

BMY takes global license to IMTX’s TCR-bispecific program—$150M up-front:

https://finance.yahoo.com/news/immatics-bristol-myers-squibb-enter-115900405.html

Under the terms of the agreement, Immatics will receive an upfront payment of $150 million as well as up to $770 million in development, regulatory and commercial milestone payments, in addition to tiered double-digit royalty payments on net sales of IMA401. Immatics retains the options to co-fund U.S. development in exchange for enhanced U.S. royalty payments and/or to co-promote IMA401 in the US.

p.s. This is the second collaboration between these companies; the first was inherited from Celgene.

[DewDiligence]

GILD vs BMY in LBCL CAR-T—who has the edge?

https://www.fiercepharma.com/pharma/bristol-myers-squibb-breyanzi-gilead-yescarta-lock-horns-car-t-therapy-earlier-lymphoma

Both Yescarta and Breyanzi are poised to take share from stemcell transplants.

[DewDiligence]

BMY boosts dividend—authorizes $15B share buyback:

https://finance.yahoo.com/news/bristol-myers-squibb-announces-dividend-115900706.html

The new annualized dividend is $2.16 (up from $1.96); at the current share price, the new payout is a yield of 3.8%.

The $15B buyback authorization does not have a time limit. (Inasmuch as BMY had $200K remaining on the old buyback authorization, the total buyback authorization is now $15.2B.)

[DewDiligence]

Reblozyl sBLA in beta thalassemia—>3/27/22 PDUFA date—(with FDA priority review):

https://www.businesswire.com/news/home/20211203005095/en

BMY is now partnered with MRK on Reblozyl development and commercialization as a result of MRK’s buyout of XLRN, which makes for an odd working relationship.

[biotech_researcher]

Being destroyed like the micro cap biotechs… puzzling..

[DewDiligence]

Deucravacitinib for psoriasis has 9/10/22 PDUFA date (with standard FDA review):

https://www.businesswire.com/news/home/20211129005192/en

The Deucra MAA in psoriasis has also been validated by the EMA.

[DewDiligence]

Mavacamten PDUFA extended 3mo to 4/28/22:

https://www.businesswire.com/news/home/20211119005267/en

The FDA simply needs more time to complete the NDA review—it has not requested any new data or analyses from BMY.

Mavacamten is the drug BMY got in the $13.1B acquisition of MYOK in Oct 2020 (#msg-158698900).

[DewDiligence]

BMY Investor Day slides (140 pages):

https://s21.q4cdn.com/104148044/files/doc_presentations/2021/2021-BMS-Investor-Event-Presentation.pdf

[DewDiligence]

BMY presents phase-2 Milvexian data at AHA:

https://www.businesswire.com/news/home/20211115005987/en

Milvexian is an oral anticoagulant that inhibits Factor XIa, a new MoA. Compared to FXa inhibitors such as Eliquis and Xarelto, Milvexian may be able to offer comparable efficacy with less bleeding risk.

BMY is developing Milvexian with JNJ, pursuant to a 2018 collaboration (#msg-140083631). BMY hopes Milvexian can replace some or all of the revenue from Eliquis, which loses exclusivity in 2028. Phase-3 trials for Milvexian are slated to start in 2022.

[DewDiligence]

BMY reports statsig DFS in neoadjuvant* NSCLC:

https://finance.yahoo.com/news/neoadjuvant-opdivo-nivolumab-plus-chemotherapy-115900324.html

These data are from the phase-3 CHECKMATE-816 study. BMY reported stellar pCR (complete pathological response) data from this trial in Apr 2021 (#msg- 163102660), but the DFS (primary endpoint) data were not yet mature then.

This result should enable Opdivo to compete with Tecentriq use in adjuvant NSCLC.

See #msg-163102660 for background info.

*Stage Ib to IIIa.

[DewDiligence]

BMY’s AHA lineup:

https://finance.yahoo.com/news/bristol-myers-squibb-present-data-115900631.html

[danoz28]

well, this stock is sure driving me crazy. goes down on decent earnings. i've felt this stock has been undervalued for years. ibd writer keeps saying patent cliffs coming soon , isn't that true for all pharma stocks? i know bmy is rumored to be buying ?aurina? for roughly $35 or 4.5B which im tired of this ceo not paying down current massive debt of $45B. with guidance around $7.50 this year and probably much higher next year wheres the wallstreet luv? my fav part of this stock is the free cash flow of 15B and growing. whats the reason any of you have invested in this stock? cheers

[DewDiligence]

BMY 3Q21 CC transcript:

https://www.fool.com/earnings/call-transcripts/2021/10/28/bristol-myers-squibb-bmy-q3-2021-earnings-call-tra/

[biotech_researcher]

Street hates the results for some reason.. Or, maybe the guidance??

[DewDiligence]

BMY 3Q21 CC slides:

https://s21.q4cdn.com/104148044/files/doc_presentations/2021/BMY-2021-Q3-Results-Investor-Presentation.pdf

[DewDiligence]

BMY 3Q21 results:

https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Reports-Third-Quarter-Financial-Results-for-2021/default.aspx

2021 non-GAAP EPS guidance is now $7.40-7.55 (up slightly from the prior guidance of $7.35-7.55.

[rosemountbomber]

Stories on the wires yesterday that BMY is showing interest in acquiring AUPH and their LN drug. We may hear more in the coming days.

[DewDiligence]

BMY will bank $1.3B from selling its 11.5% XLRN stake in MRK’s buyout, assuming the deal goes through:

https://finance.yahoo.com/news/bristol-myers-plans-exit-acceleron-023231535.html

[DewDiligence]

BMY’s Deucravacitinib fails phase-2 trial in UC:

https://finance.yahoo.com/news/bristol-myers-squibb-provides-phase-105900443.html

"While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical program in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases.

[DewDiligence]

FDC of Opdivo/Relatimab—(anti-LAG-3)—has 3/19/22 PDUFA date for 1L-melanoma (with FDA priority review):

https://finance.yahoo.com/news/u-food-drug-administration-accepts-105900488.html

[DewDiligence]

Nimbus Therapeutics (private) starts phase-2b of TYK2 inhibitor in psoriasis:

https://www.businesswire.com/news/home/20210914005150/en

This is potential competition for BMY’s Deucravacitinib.

[DewDiligence]

FDA approves Opdivo monotherapy in adjuvant MIUC:

https://www.businesswire.com/news/home/20210820005285/en

Bristol Myers Squibb today announced that Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks…was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

The approval is based on the CHECKMATE-274 study (#msg-161630427).

[DewDiligence]

Confirmed on today’s CC that the Opdivo/Yervoy arm in CHECKMATE-649 did not show a statsig benefit vs chemo. (See bottom paragraph of the post this is replying to.)

[DewDiligence]

BMY 2Q21 CC slides:

https://s21.q4cdn.com/104148044/files/doc_presentations/2021/BMY-2021-Q2-Results-Investor-Presentation.pdf

[DewDiligence]

BMY 2Q21 results—2021_non-GAAP_EPS_guidance remains $7.35-7.55:

https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Reports-Second-Quarter-Financial-Results-for-2021/default.aspx

[DewDiligence]

BMY, BBIO ink clinical-trial collaboration to test Opdivo + BBP-398 (SHP2 inhibitor) in NSCLC and other solid cancers:

https://finance.yahoo.com/news/bridgebio-announces-clinical-collaboration-bristol-113000704.html

The collaboration will also include the initiation of a Phase 1/2 study to evaluate the safety and preliminary efficacy of BBP-398 in combination with both OPDIVO as doublet therapy, and OPDIVO plus a KRASG12C inhibitor as triplet therapy in non-small cell lung cancer (NSCLC) with KRAS mutations, as first- and second-line treatment options.

Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Bristol Myers Squibb will provide nivolumab. Both BridgeBio and Bristol Myers Squibb will share the cost of clinical development activities for the combination trial.

[DewDiligence]

Opdivo/Yervoy fails to show statsig OS benefit compared to Erbitux/chemo in first-line SCCHN:

https://www.businesswire.com/news/home/20210716005019/en/Bristol-Myers-Squibb-Provides-Update-on-CheckMate--651-Trial-Evaluating-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Versus-EXTREME-Regimen-as-First-Line-Treatment-for-Squamous-Cell-Carcinoma-of-the-Head-and-Neck

These results are from the CHECKMATE-651 study.

[BottomBounce]

$BMY or IBIO https://www.globenewswire.com/en/news-release/2021/07/08/2260252/0/en/iBio-Establishes-Oncology-Drug-Discovery-Pipeline-with-Three-New-Antibody-Programs.html

[DewDiligence]

BMY opys-in_for PRTA's anti-tau_compound, PRX005:

https://finance.yahoo.com/news/prothena-announces-bristol-myers-squibb-123000524.html

PRTA gets $80M from BMY for the opt-in and is eligible to receive as much as $2.2B in regulatory/commercial milestone payments.

BMY inherited this collaboration from CELG (#msg-139431013).

[DewDiligence]

BMY settles US Revlimid-patent case with another challenger—Sun Pharma—on similar terms to prior settlements—(e.g. #msg-158350306):

https://www.fiercepharma.com/manufacturing/bristol-myers-settles-sun-pharma-for-limited-revlimid-generic-launch-2022

The basic framework of these settlements is: a) the generic-drug companies who settled can launch limited quantities their Revilimid generics in the US market in 2022 (Mar 2022 for Natco [the first company to settle with BMY]; and somewhat later in 2022 for RDY, Cipla, and Sun Pharma); and 2) the generic-drug companies who settled can launch unlimited quantities of their Revlimid generics starting on 1/31/26.

[DewDiligence]

BMY, Eisai ink global collaboration for MORAb-202 ADC:

https://investors.bms.com/iframes/press-releases/press-release-details/2021/Eisai-and-Bristol-Myers-Squibb-Enter-Into-Global-Strategic-Collaboration-for-Eisais-MORAb-202-Antibody-Drug-Conjugate/default.aspx

Eisai Co., Ltd. and Bristol-Myers Squibb Company announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC). MORAb-202 is Eisai’s first ADC and combines Eisai’s in house developed anti-folate receptor alpha (FR-alpha) antibody, and Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. It is a potential best-in-class FR-alpha ADC with a favorable pharmacology profile and demonstrated single agent activity in patients with advanced solid tumors.

Eisai is currently investigating MORAb-202 in FR-alpha-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States. The companies are planning to move into the registrational stage of development for this asset as early as next year.

Under the agreement, Eisai and Bristol Myers Squibb will jointly develop and commercialize MORAb-202 in the following collaboration territories: Japan; China; countries in the Asia-Pacific region; the United States; Canada; Europe, including the European Union and the United Kingdom; and Russia. Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories. Eisai will remain responsible for the manufacturing and supply of MORAb-202 globally.

Under the financial terms of the agreement, Bristol Myers Squibb will pay $650 million U.S. dollars to Eisai including $200 million U.S. dollars as payment toward Eisai research and development expenses. Eisai is also entitled to receive up to $2.45 billion U.S. dollars in potential future development, regulatory, and commercial milestones. The parties will share profits, research and development and commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories. Eisai is expected to book sales of MORAb-202 in Japan, China, countries in the Asia-Pacific region, Europe and Russia. Bristol Myers Squibb is expected to book sales of MORAb-202 in the United States and Canada.

This compound is clearly on the fast track.

[DewDiligence]

Reblozl helps beta-thalassemia patients remain non-transfusion-dependent:

https://finance.yahoo.com/news/bristol-myers-squibb-acceleron-present-070000378.html

See #msg-154788821 for related info.

[DewDiligence]

Breyanzi shows phase-3 statsig-superior EFS compared to SoC (high-dose chemo followed by stem-cell transplant) in second-line, large B-cell lymphoma:

https://www.businesswire.com/news/home/20210610005259/en

Bryanzi’s existing label includes only the third-line setting (#msg-161552697).

[DewDiligence]

BMY’s ASCO CC slides:

https://s21.q4cdn.com/104148044/files/doc_presentations/2021/ASCO-Investor-Presentation.pdf

[DewDiligence]

BMY releases additional Opdivo/chemo and Opdivo/Yervoy data from the CHECKMATE-648 study in certain GI cancers:

https://www.businesswire.com/news/home/20210603005918/en

In Apr 2021, BMY announced that this study hit its OS primary endpoint for both the Opdivo/chemo and Opdivo/Yervoy arms, compared to chemo alone (#msg-163050617), but no details were available until now.

The dataset is complex and you need a scorecard to understand all of it; fortunately, Evaluate Vantage has provided one:

https://www.evaluate.com/vantage/articles/events/conferences/asco-2021-bristol-makes-more-progress-stomach-cancer

Note: Opdivo/chemo is already FDA-approved in a different kind of metastatic GI cancer, based on the CHECKMATE-649 (rather than -648) study (#msg-163247972); and Opdivo monotherapy is already FDA-approved in adjuvant esophageal cancer, based on the CHECKMATE-577 study (#msg-163936079).

[DewDiligence]

FDA approves Zeposia for_moderate/severe ulcerative colitis:

https://finance.yahoo.com/news/u-food-drug-administration-approves-201300046.html

Zeposia was approved in 2020 by FDA and EMA for relapsing MS (#msg-154586608, #msg-154614638). The label expansion to UC is BMY’s first GI-immunology approval.

[DewDiligence]

FDA approves Opdivo monotherapy in adjuvant esophageal cancer (for patients who have residual pathological disease following chemo/radiation in the neoadjuvant setting and a complete resection):

https://finance.yahoo.com/news/u-food-drug-administration-approves-172600155.html

The approval was based on the CHECKMATE-577 study. Today was the PDUFA date.

This is Opdivo’s second approval in an adjuvant setting—the other is in melanoma.

[DewDiligence]

BMY’s Relatlimab—(anti-LAG-3)—impresses_in_first-line_melanoma:

https://investors.bms.com/iframes/press-releases/press-release-details/2021/Bristol-Myers-Squibb-Announces-LAG-3-Blocking-Antibody-Relatlimab-and-Nivolumab-Fixed-Dose-Combination-Significantly-Improves-Progression-Free-Survival-vs.-Opdivo-nivolumab-in-Patients-with-Previously-Untreated-Metastatic-or-Unresectable-Melanoma/default.aspx

Bristol Myers Squibb today announced results from the Phase 2/3 RELATIVITY-047 trial, which showed that the fixed-dose combination of relatlimab, a LAG-3-blocking antibody, and nivolumab, administered as a single infusion, demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit compared to Opdivo (nivolumab) alone in patients with previously untreated metastatic or unresectable melanoma.

This is the first regimen to demonstrate a statistical benefit over anti-PD-1 monotherapy in metastatic melanoma. Among patients treated with the combination, the median PFS (mPFS) was significantly longer at 10.12 months (95% Confidence Interval [CI]: 6.37-15.74) vs. 4.63 in those who received Opdivo (95% CI: 3.38–5.62); (Hazard Ratio [HR] 0.75; 95% CI: 0.62-0.92, p=0.0055). The PFS benefit of the fixed-dose combination was observed early, at the time of the first scan, and was consistent over time. In exploratory, descriptive analyses, the combination of relatlimab and nivolumab extended PFS regardless of pre-specified subgroups and stratification factors.

…The safety profile of the fixed-dose combination of relatlimab and nivolumab was manageable and consistent with those previously reported for relatlimab and nivolumab. No new safety signals or new types of clinically important events were identified with the fixed-dose combination when compared to Opdivo monotherapy. Grade 3/4 drug-related adverse events were 18.9% in the combination arm compared to 9.7% in the Opdivo arm. [The Opdivo/Yervoy combination in this setting had a Grade-3/4 rate of about 60%.]

… RELATIVITY-047 (CA224-047) is a global, randomized, double-blind Phase 2/3 study evaluating the fixed-dose combination of relatlimab and nivolumab in patients with previously untreated metastatic or unresectable melanoma versus Opdivo alone. The primary endpoint of the trial is progression-free survival (PFS) by Blinded Independent Central Review (BICR) and the secondary endpoints are overall survival (OS) and objective response rate (ORR). A total of 714 patients were randomized 1:1 to receive a fixed-dose combination of relatlimab 160 mg and nivolumab 480 mg or Opdivo 480 mg by intravenous infusion every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent. Follow-up for the secondary endpoints of OS and ORR is ongoing and the Company remains blinded.

In this setting, Relatlimab + Opdivo may offer efficacy similar to Opdivo + Yervoy with much less toxicity.

BMY reported on 3/25/21 (#msg-162784750) that this trial (RELATIVITY-047) met its PFS primary endpoint, but no further details were available until now.

[DewDiligence]

BMY inks AI-based drug-discovery_collaboration_with_(private)_Exscientia:

https://www.businesswire.com/news/home/20210519005180/en

Exscientia…announced today that it has entered into a collaboration agreement with Bristol-Myers Squibb… The collaboration will use AI to accelerate the discovery of small molecule therapeutic drug candidates in multiple therapeutic areas, including oncology & immunology.

The agreement includes up to $50 million in upfront funding, up to $125 million in near to mid-term potential milestones, and additional clinical, regulatory and commercial payments that take the potential value of the deal beyond $1.2 billion. Exscientia will also receive tiered royalties on net sales of any marketed drug products resulting from the collaboration.

This expanded collaboration builds upon Exscientia’s existing collaboration with Bristol Myers Squibb that was initiated in 2019 with Celgene prior to Celgene’s acquisition by Bristol Myers Squibb.

This makes two material biz-dev deals in two days for BMY.

[DewDiligence]

BMY inks drug-development deal with AGEN:

#msg-163868798
#msg-163877262

This deal was announced yesterday (5/18/21).

[DewDiligence]

BMY’s ASCO/EHA lineup:

https://finance.yahoo.com/news/bristol-myers-squibb-presents-research-154300423.html

[DewDiligence]

PDUFA for Opdivo in adjuvant MUIC is 9/3/21 (with priority review):

https://www.businesswire.com/news/home/20210430005094/en

The sBLA is based on the CHECKMATE-274 study.

[JohnLocke101]

62.58 - close enough