Bristol-Myers Squibb 株価情報 (NYSE: BMY)

Bristol-Myers Squibb (NYSE:BMY) 株価情報

BRISTOL-MYERS SQUIBB CO

Bristol-Myers Squibb

Bristol-Myers Squibb discovers, develops, and markets drugs for various therapeutic areas, such as cardiovascular, cancer, and immune disorders. A key focus for Bristol is immuno-oncology, where the firm is a leader in drug development. Bristol derives close to 70% of total sales from the US, showing a higher dependence on the US market than most of its peer group.

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投資家の恐怖指数は改善｜ダウは350ポイント以上の下落を記録

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb Co

BRISTOL-MYERS SQUIBB $2PR by Bristol-Myers Squibb Co.

The U.S. Food and Drug Administration (FDA) approved label updates for Bristol Myers Squibb &amp; Co.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) for large B cell lymphoma (LBCL) and other lymphomas and Abecma (idecabtagene vicleucel; ide-cel) <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">for multiple myeloma</a>.
In the first quarter of 2025, Bristol Myers Squibb reported Abecam sales of $103 million, up 26% year over year, and Breyanzi sales <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44986472/bristol-myers-delivers-upbeat-2025-forecast-after-beating-q1-wall-street-expectations-says-guidance-includes-china-tariffs-impact" rel="noreferrer noopener">jumped 146% to $204 million</a>.
The company said in a statement on Thursday that these label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46131412/u-s-food-and-drug-administration-approves-streamlined-patient-monitoring-requirements-and-removal-" rel="noreferrer noopener">was initially approved</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/legal/25/06/46098969/bristol-myers-faces-scrutiny-for-allegedly-rigging-market-on-2b-cancer-drug" rel="noreferrer noopener">Bristol Myers Faces Scrutiny For Allegedly Rigging Market On $2 Billion Cancer Drug</a>
The company says about 2 in 10 eligible patients receive it due to the confluence of complex logistical and geographic barriers affecting patients and providers.
The FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma across both labels.
These prolonged requirements burdened healthcare delivery systems and certain patients and their care partners, particularly those who live far from certified cell therapy treatment centers.
Driving restrictions post-treatment have been reduced from eight weeks to two weeks. The requirement to remain within proximity of a healthcare facility after infusion has also been shortened from four weeks to two weeks.
The FDA has also approved the removal of the REMS requirement from each product label. A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies.
The FDA has since determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies.
In April 2024, the FDA said it would now&nbsp;require boxed warnings, the highest safety-related caution for medications, for all chimeric antigen <a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38334543/fda-mandates-boxed-warning-for-bristol-myers-johnson-johnson-car-t-based-blood-cancer-therapies" rel="noreferrer noopener">receptor (CAR) T-cell therapies</a>.&nbsp;
According to the agency, these blood cancer treatments may pose a&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36736043/focus-on-bristol-myers-gilead-sciences-johnson-johnson-novartis-fda-to-issue-classwide-black-box-" rel="noreferrer noopener">risk of secondary cancers</a>.
Price Action: BMY stock is trading higher by 0.40% to $46.84 last check Friday.
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FDA Eases Rules For Bristol Myers' Cell Therapies For Blood Cancers

<ul>
<li>Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access</li>
<li>Only about 2 in 10 eligible patients currently receive cell therapy treatment; today's announcement will reduce unnecessary barriers for patients and providers</li>
</ul>

Reported Earlier, Bristol Myers Squibb's Breyanzi And Abecma Receive FDA Label Revisions Removing REMS And Reducing Monitoring Burdens

Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) and its subsidiary Celgene Inc. face antitrust <a href="https://www.benzinga.com/topic/legal">allegations in a civil lawsuit</a>.
Cigna Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CI#NYSE">CI</a>) accuses both companies of unlawfully extending their monopoly on the multiple myeloma drug pomalidomide, marketed as Pomalyst.
The complaint argues that the pharmaceutical giants engaged in fraudulent patent practices, abuse of the court system, and anticompetitive deals to delay generic competition, resulting in billions of dollars in overcharges to drug purchasers.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45723383/bristol-myers-inks-11-billion-licensing-pact-with-biontech-for-bispecific-cancer-drug" rel="noreferrer noopener">Bristol Myers Inks $11 Billion Licensing Pact With BioNTech For Bispecific Cancer Drug</a>
Purchasers of this $2.25 billion a year drug—like Cigna—have overpaid for pomalidomide by many hundreds of millions, &#8220;if not billions, of dollars,&#8221; the lawsuit alleged.
Bloomberg Law published a copy of the lawsuit online Tuesday.
According to the lawsuit, Celgene secured method-of-use and formulation patents for pomalidomide by intentionally misleading the U.S. Patent and Trademark Office.
The company allegedly withheld information about earlier patents from a Boston Children's Hospital doctor and submitted false expert declarations claiming they overcame "unexpected" drug stability issues.
The suit claims those statements were knowingly false, as scientists had long addressed such challenges with thalidomide analogs through standard techniques. Without this fraudulent conduct, the patents would not have been granted, and generics could have entered the market earlier.
Celgene also allegedly filed a series of sham lawsuits to block potential competitors, fully aware that the patents in question were either invalid or easily circumvented.
These lawsuits were based on patents obtained through fraud or were so weak that no reasonable company could expect to win. Despite this, Celgene pursued litigation to delay generic entry and protect inflated drug prices.
&#8220;The lawsuits were a sham because no reasonable litigant in Celgene's position would have expected to prevail in showing that the patents at issue (method of treatment, formulation, and crystal form) were both valid and infringed,&#8221; Cigna <a target="_blank" href="https://www.bloomberglaw.com/public/desktop/document/vCelgeneCorporationetalDocketNo125cv05237SDNYJun242025CourtDocket?doc_id=X23NN7JB1SC8AMBB0IK58OQETGN" rel="noreferrer noopener">said</a> in the complaint.
The complaint further alleges that Celgene and Bristol Myers made reverse payments to generic manufacturers to delay market entry.
These settlements, including those tied to another Celgene drug, Revlimid, created coordinated output restrictions and delivered hundreds of millions in excess profits to generic competitors.
The arrangement maintained artificially high prices for Revlimid and Pomalyst. The generic launch for Pomalyst—set for the first quarter of 2026—coincides with the end of the Revlimid restriction. 
The lawsuit claims that Celgene paid generic drugmakers—Aurobindo, Eugia, Breckenridge, Natco, and Teva—to drop their efforts to challenge patents for the drug pomalidomide and delay launching cheaper versions in the U.S. market.
It also alleges that Celgene and Bristol Myers delayed generic versions of Pomalyst by offering large payments for related settlements over another drug, Revlimid.
Pomalyst and Revlimid are prescription medicines used to treat adults with multiple myeloma.
During the first quarter of 2025, Revlimid sales reached $936 million, down 44% year over year. Pomalyst/Imnovid sales fell <a href="https://www.benzinga.com/general/biotech/25/04/44986472/bristol-myers-delivers-upbeat-2025-forecast-after-beating-q1-wall-street-expectations-says-guidance-includes-china-tariffs-impact" target="_blank" rel="noreferrer noopener">24% to $658 million</a>.
Benzinga reached out to Bristol Myers for commentary but have not heard back. 
Price Action: BMY stock is down 0.59% at $46.75 at the last check on Wednesday.
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Bristol Myers Faces Scrutiny For Allegedly Rigging Market On $2 Billion Cancer Drug

Reuters Cites Court Filing Saying Cigna Files Antitrust Lawsuit Accusing Bristol Myers Of Illegally Extending Monopoly On Pomalyst Multiple Myeloma Drug, Causing Purchasers To Overpay

95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response, with 62.1% achieving complete response and 88.6% maintaining a response at 24 months
New data show liso-cel demonstrated high rates of durable responses and a consistent safety profile in a fifth cancer type, the most of any CD19-directed CAR T cell therapy
Additional liso-cel data at ICML 2025 further reinforce BMS' commitment to unlocking the full potential of this therapy for patients
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com%2F&amp;esheet=54275367&amp;newsitemid=20250613870408&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=d665851409cd5753f968a6745c7e20f9">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) today announced the first disclosure of the primary analysis results of the marginal zone lymphoma (MZL) cohort of TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory disease. The new data will be presented at the 2025 International Conference on Malignant Lymphoma (ICML) in an oral presentation on June 19, building on <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fnews.bms.com%2Fnews%2Fcorporate-financial%2F2025%2FBristol-Myers-Squibb-Announces-Positive-Topline-Results-for-Breyanzi-lisocabtagene-maraleucel-in-Adult-Patients-with-Relapsed-or-Refractory-Marginal-Zone-Lymphoma%2Fdefault.aspx&amp;esheet=54275367&amp;newsitemid=20250613870408&amp;lan=en-US&amp;anchor=positive+topline+results&amp;index=2&amp;md5=ab804680ec7fa20a8268604cd3793fbb">positive topline results</a> announced in February.

Bristol Myers Squibb Announces First Disclosure Of Primary Analysis Results Of MZL Cohort Of TRANSCEND FL, Phase 2, Single-Arm Study Evaluating Breyanzi In Patients With Relapsed Or Refractory Disease

BioNTech SE&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) on Thursday agreed to acquire CureVac N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) in an <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">all-stock transaction</a>.
According to the agreement, shareholders can exchange CureVac shares for around $5.46 in BioNTech ADSs. This equates, roughly, to an equity value of <a href="https://www.benzinga.com/pressreleases/25/06/g45900311/biontech-announces-strategic-transaction-to-acquire-curevac-in-public-exchange-offer" target="_blank" rel="noreferrer noopener">$1.25 billion</a>.
The consideration is subject to a collar mechanism. If the 10-day volume weighted average price of the BioNTech ADSs ending on the fifth business day before the offer&#8217;s closing exceeds $126.55, the exchange ratio would be 0.04318. If the VWAP is lower than $84.37, the exchange ratio would be 0.06476.
At closing, CureVac shareholders expect to own between 4% and 6% of BioNTech.
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With the acquisition, BioNTech aims to strengthen the research, development, manufacturing, and commercialization of investigational mRNA-based cancer immunotherapy.
The strategic transaction will complement BioNTech&#8217;s capabilities and proprietary technologies in mRNA design, delivery formulations, and manufacturing.
For BioNTech, this transaction marks the next milestone in the execution of its oncology strategy which focuses on two pan-tumor programs, mRNA-based cancer immunotherapy candidates, and BNT327, a PD-L1xVEGF-A bispecific antibody candidate.
Following the transaction&#8217;s closing, CureVac&#8217;s operating subsidiary will become a wholly owned subsidiary of BioNTech. As part of this plan, BioNTech will integrate CureVac&#8217;s research and manufacturing site in Tübingen.
The transaction was unanimously approved by BioNTech&#8217;s and CureVac&#8217;s management and supervisory boards. The transaction is expected to close in 2025.
As of March 31, BioNTech had 15.9 billion euros in cash, cash equivalents, <a href="https://www.benzinga.com/25/05/45205736/biontech-appoints-novartis-executive-as-finance-chief-reaffirms-2025-guidance-focuses-on-oncology-expansion" target="_blank" rel="noreferrer noopener">and security investments</a>.
Earlier in June, BioNTech and&nbsp;Bristol Myers Squibb&nbsp;&amp; Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) entered into a co-development and <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45723383/bristol-myers-inks-11-billion-licensing-pact-with-biontech-for-bispecific-cancer-drug" rel="noreferrer noopener">co-commercialization agreement</a>.
The pact focuses on BioNTech&#8217;s investigational bispecific antibody BNT327 across numerous solid tumor types.
Bristol Myers Squibb will pay BioNTech $1.5 billion upfront and $2 billion in non-contingent anniversary payments through 2028.
In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones.
In March, CureVac said the European Patent Office (EPO) confirmed the validity of CureVac&#8217;s European patent EP 3 708 668 B1 subject to amendments to specify <a target="_blank" href="https://www.benzinga.com/25/03/44535393/european-patent-office-rules-vaccine-developer-curevacs-amended-patent-valid-stock-jumps" rel="noreferrer noopener">the scope of protection</a>.
The opposition division largely dismissed BioNTech&#8217;s original opposition filed in April 2023, challenging the patent&#8217;s validity and maintaining it in amended form.
Price Action: BNTX stock is up 1.22% at $106.75, and CVAC stock is up 33.2% at $5.42 during the premarket session at the last check on Thursday.
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BioNTech Expands mRNA Cancer Portfolio With CureVac $1.25 Billion All-Stock Deal

Innovative Agents Highlight Growth of Targeted Protein Degradation Platform and BMS' Leadership in Innovative Cancer Therapies
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com%2F&amp;esheet=54272918&amp;newsitemid=20250612347504&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=d564e2f69d9f1c2ea34e8ca51e3ad252">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) today announced the presentation of new data from its targeted protein degradation platform during the 2025 European Hematology Association (EHA) Annual Congress being held from June 12-15 in Milan, Italy. Presentations feature updated clinical findings on the company's investigational oral CELMoD&#x2122; agents mezigdomide and iberdomide in multiple myeloma, and golcadomide in non-Hodgkin lymphoma, as well as the first results evaluating the company's first-in-class, oral BCL6 ligand-directed degrader (LDD) (BMS-986458) in non-Hodgkin lymphoma.
The latest data presented for the three lead CELMoD agents and BCL6 LDD underscore the potential impact that these therapies may have in addressing significant unmet medical needs in hematologic malignancies. These agents are part of continuing research across targeted protein degradation at Bristol Myers Squibb, which also encompasses additional CELMoD agents, LDDs and degrader antibody conjugates (DACs) across blood cancers and solid tumors, as well as non-malignant hematologic disorders.
Protein degraders, like CELMoD agents and LDDs, are therapies designed to target and degrade specific proteins that drive diseases, including many proteins that are difficult to target through conventional small-molecule inhibitors. These innovative agents have the possibility to enhance the efficacy of existing therapies and overcome resistance in various malignancies, potentially improving patient outcomes.

Bristol Myers Squibb Presents Updated Clinical Findings On CELMoD Agents Mezigdomide And Iberdomide In Multiple Myeloma, Golcadomide In Non-Hodgkin Lymphoma, And First Results Evaluating Oral BCL6 LDD In Non-Hodgkin Lymphoma, At EHA 2025

Significantly more patients treated with Sotyktu achieved improvements in joint and skin symptoms, measures of disease activity and quality of life at Week 16 in POETYK PsA-1
New data from POETYK PsA-2 trial demonstrated that meaningful clinical responses continued to improve and outcomes were maintained through Week 52
Sotyktu demonstrated safety consistent with the established clinical profile and was well tolerated in both studies, with no new safety signals
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com%2F&amp;esheet=54271967&amp;newsitemid=20250610213248&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=9b6ef596309f7eebddfadc2dc480b6d2">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) today announced positive data from the pivotal Phase 3 POETYK PsA-1 trial (IM011-054) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD). The trial met its primary endpoint, with a significantly greater proportion of patients treated with Sotyktu achievingACR20 response (at least a 20 percent improvement in signs and symptoms of disease) compared with placebo at Week 16 (54.2% versus 34.1%, respectively; p&lt;0.0001). The safety profile of Sotyktu through 16 weeks of treatment was consistent with what has been reported throughout the clinical trial programs for Sotyktu, including the Phase 3 POETYK PsA-2 trial and the Phase 3 moderate-to-severe plaque psoriasis (PsO) clinical trials.
The data for POETYK PsA-1 are being presented as a late-breaking abstract (#LB0001) at the European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain, taking place June 11-14, 2025.

Bristol Myers Squibb Announces Phase 3 POETYK PsA-1 Trial Met Primary Endpoint For Sotyktu In Psoriatic Arthritis

Consideration composed of a $350m up-front payment and up to $1.0bn in development, regulatory and commercial milestones, along with mid-single to low double-digit royalties on Global Net Sales

Reported Earlier, Philochem Licenses Global Rights To Prostate Cancer Radiopharmaceutical OncoACP3 To RayzeBio, A Bristol-Myers Squibb Company, In Deal Worth Up To $1.35B

AnaptysBio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANAB#NASDAQ">ANAB</a>) on Tuesday released updated data from the Phase 2b trial of rosnilimab, a PD-1 depleter and agonist, for <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">rheumatoid arthritis</a>.
In the 424-patient 2b trial, rosnilimab achieved JAK-like efficacy on multiple clinically meaningful measures, including low disease activity (LDA) and remission on the Clinical Disease Activity Index (CDAI), as well as ACR70 response, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g45757627/anaptys-announces-positive-rosnilimab-data-updated-through-six-months-in-robust-phase-2b-trial-in-" rel="noreferrer noopener">over six months</a>.
Furthermore, responses were then durable for at least two months off the drug.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42445688/anaptysbio-discontinues-investment-in-eczema-candidate-after-disappointing-data" rel="noreferrer noopener">AnaptysBio Discontinues Investment In Eczema Candidate After Disappointing Data</a>
Rosnilimab was safe and well tolerated, particularly compared to standard-of-care biologics or JAKs.
All three doses (100mg Q4W, 400mg Q4W, 600mg Q2W) achieved statistically significant reductions in DAS-28 CRP and ACR20 at Week 12 versus placebo.
CDAI LDA (≤10) was achieved by 45% of 318 rosnilimab patients by Week 12, increasing to 69% (220 responders) across all doses by Week 14.
The company aims to complete its Phase 2 study for rosnilimab in ulcerative colitis/UC, with initial data expected in the fourth quarter of 2025.
As of the March 11, 2025&nbsp;data cutoff date, 83% were still in LDA at Week 34 across all doses. Of the remaining 17% of patients who did not sustain CDAI LDA at Week 34, most remained near the cutoff of CDAI=10, with a median CDAI of 13.
Rosnilimab demonstrated clinically meaningful improvements that deepened through Week 28 across multiple validated patient-reported outcomes, including the pain visual analog scale (VAS) and the health assessment questionnaire, or HAQ-Disability Index (DI), a self-reporting tool to measure function and disability.
HC Wainwright analyst Emily Bodnar wrote on Wednesday, &#8220;Given the data showcase a positive holistic story for rosnilimab in RA, we are increasingly positive on upcoming UC data.&#8221;
Bodnar upgraded AnaptysBio from Neutral to Buy, raising the price target<a href="https://www.benzinga.com/quote/ANAB/analyst-ratings" target="_blank" rel="noreferrer noopener"> from $22 to $38</a>.
HC Wainwright Highlights Competitor Datasets
Data using non-responder imputation (NRI) from Week 24 of the SELECT-CHOICE trial, which compared AbbVie Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) Rinvoq vs Bristol Myers Squibb&nbsp;&amp; Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Orencia in rheumatoid arthritis (RA), showed similar results for both drugs. These findings align with the results seen for the company&#8217;s rosnilimab at Week 28, even though about 29% of patients had previously been treated with JAK inhibitors.
In contrast, Eli Lilly And Co&#8216;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) now-discontinued PD-1 agonist peresolimab showed a drop in CDAI LDA rates—from 55% at Week 14 to 37% at Week 24. This is notably lower than the 53–63% range reported for rosnilimab at Week 28.
Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) is also set to present early data for its PD-1 agonist at the upcoming EULAR conference, though its study is smaller than AnaptysBio&#8217;s.
Price Action: ANAB stock is down 12.1% at $20.66 at the last check on Wednesday.
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AnaptysBio's Arthritis Drug Matches Top Therapies In Phase 2 Trial, Analyst Sees Turning Point

BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) and Bristol Myers Squibb &amp; Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) entered into a co-development and <a href="https://www.benzinga.com/pressreleases/25/06/b45717442/biontech-and-bristol-myers-squibb-announce-global-strategic-partnership-to-co-develop-and-co-comme" target="_blank" rel="noreferrer noopener">co-commercialization agreement</a>.
The pact focuses on BioNTech&#8217;s investigational bispecific antibody BNT327 across numerous <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">solid tumor types</a>.
Under the agreement, BioNTech and Bristol Myers Squibb will work jointly to broaden and accelerate the development of this clinical candidate.
Also Read: <a href="https://www.benzinga.com/25/05/45205736/biontech-appoints-novartis-executive-as-finance-chief-reaffirms-2025-guidance-focuses-on-oncology-expansion" target="_blank" rel="noreferrer noopener">BioNTech Appoints Novartis Executive As Finance Chief, Reaffirms 2025 Outlook Focusing on Oncology Expansion</a>
BioNTech&#8217;s BNT327 is currently under extensive evaluation in multiple ongoing clinical trials, with over 1,000 patients having received the treatment to date. 
These evaluations include global Phase 3 trials with registrational potential, investigating BNT327 as a first-line treatment for both extensive-stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC). 
Furthermore, BioNTech plans to initiate an additional global Phase 3 trial by the end of 2025 to assess the candidate&#8217;s efficacy in treating triple-negative breast cancer (TNBC).
Under the terms of the agreement, the companies will jointly develop and commercialize BNT327, including the development of BNT327 as monotherapy and in combination with other products. 
Both companies have the right to independently develop BNT327 in further indications and combinations, including combinations of BNT327 with proprietary pipeline assets.
Bristol Myers Squibb will pay BioNTech $1.5 billion in an upfront payment and $2 billion in non-contingent anniversary payments through 2028.
These tax-deductible charges will be recorded as Acquired IPR&amp;D Expense when incurred, with the $1.5 billion being incurred in Q2.
In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones.
BioNTech and Bristol Myers Squibb will share joint development and manufacturing costs on a 50:50 basis, subject to certain exceptions. Global profits/losses will be equally shared between BioNTech and Bristol-Myers Squibb.
In May, Bristol-Myers Squibb agreed to pay $350 million to the State of Hawaii to settle claims related to the prescription drug Plavix, an antiplatelet drug that prevents blood clots by keeping platelets in the blood from coming&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45389547/bristol-myers-squibb-strikes-350-million-deal-to-end-hawaiis-plavix-lawsuit" rel="noreferrer noopener">together and making clots</a>.
The agreement resolves a lawsuit filed by the state that alleged the pharmaceutical company engaged in deceptive practices surrounding the development, labeling, and marketing of the drug.
Price Action: BNTX stock is trading higher by 14.8% to $109.95, and BMY stock is trading lower by 0.62% to $47.98 at last check Monday.
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Photo via Shutterstock

Bristol Myers Inks $11 Billion Licensing Pact With BioNTech For Bispecific Cancer Drug

<ul>
<li>BNT327, BioNTech's PD-L1xVEGF-A bispecific antibody, is a clinically advanced investigational immunotherapy candidate with the potential to surpass current checkpoint inhibitor outcomes and set a new standard of care in multiple tumor types</li>
<li>The co-development and co-commercialization collaboration with a 50/50 profit/loss split will leverage both partners' expertise, resources and global footprint to accelerate BNT327's path towards potential regulatory approvals and market launches</li>
<li>BioNTech and Bristol Myers Squibb will jointly execute a broad clinical development program to evaluate and advance BNT327 across numerous solid tumor types</li>
</ul>
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.biontech.com%2Fen&amp;esheet=54263388&amp;newsitemid=20250602838823&amp;lan=en-US&amp;anchor=BioNTech+SE&amp;index=1&amp;md5=1b483074285e1f354b050f382ec03fb3">BioNTech SE</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>, "BioNTech"))) and <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.bms.com%2F&amp;esheet=54263388&amp;newsitemid=20250602838823&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=2&amp;md5=83c6c6eeb4378c5bb6d68c8e39efc4ff">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>, "BMS"))) today announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech's investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate.

BioNTech And Bristol Myers Squibb Partner To Advance Bispecific Antibody BNT327 For Solid Tumors

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com%2F&amp;esheet=54260725&amp;newsitemid=20250527346996&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=e7f93e68b9084ecd1baf82bbde47a358">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) today announced that the European Commission (EC) has approved a new Opdivo&#xAE; (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Opdivo SC, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), has been approved for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy&#xAE; (ipilimumab)combination therapy, or in combination with chemotherapy or cabozantinib.
"The EC's decision to approve Opdivo SC ushers in a new era of cancer care in which we are able to deliver a 3- to 5-minute injection of a treatment that has shown consistent efficacy and comparable safety to intravenous Opdivo, which changed the cancer treatment landscape over a decade ago," said Dana Walker, M.D., M.S.C.E., Opdivo global program lead, Bristol Myers Squibb. "BMS is committed to advancing medicines that help improve the patient experience, and with the approval of Opdivo SC in the European Union, we are delivering on this goal."
The positive EC decision is based on results from the CheckMate -67T clinical trial and additional data that demonstrated comparable pharmacokinetics (PK) and safety profiles between Opdivo SC and IV Opdivo. The CheckMate –67T clinical trial showed noninferiority of PK primary endpoints, Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state), with Opdivo SC vs. IV Opdivo in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had received no more than two prior lines of systemic therapy but had not received prior immuno-oncology therapy. The geometric mean ratio (GMR) for Cavgd28 was 2.10 (90% CI: 2.00-2.20) and the GMR for Cminss was 1.77 (90% CI: 1.63-1.93). Additionally, as a key powered secondary endpoint, the objective response rate (ORR) in the Opdivo SC arm (n=248) was 24% (95% CI: 19-30), compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247), showing that Opdivo SC has similar efficacy compared to IV Opdivo. The safety profile of Opdivo SC remained consistent with the IV formulation.
The pharmacokinetics, efficacy and safety results from CheckMate -67T were presented at the 2024 <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fnews.bms.com%2Fnews%2Fdetails%2F2024%2FSubcutaneous-Nivolumab-nivolumab-and-hyaluronidase-Shows-Noninferiority-Compared-to-Intravenous-Opdivo-nivolumab-in-Advanced-or-Metastatic-Clear-Cell-Renal-Cell-Carcinoma-in-CheckMate--67T-Trial%2Fdefault.aspx&amp;esheet=54260725&amp;newsitemid=20250527346996&amp;lan=en-US&amp;anchor=American+Society+of+Clinical+Oncology+%28ASCO%26%23174%3B%29&amp;index=2&amp;md5=42f55650523ff910e96b5bf4a257bb10">American Society of Clinical Oncology (ASCO&#xAE;)</a> Genitourinary Cancers Symposium. Additional analyses were presented at the 2024 ASCO Annual Meeting, the 2024 European Society for Medical Oncology (ESMO) Congress, and published in the Annals of Oncology.
"As the first and only subcutaneously administered PD-1 inhibitor approved in the European Union, subcutaneous nivolumab is helping to transform the treatment landscape for eligible patients by giving them a new way to potentially receive the same benefits of the IV formulation of nivolumab, in a more convenient manner," said Laurence Albiges, M.D., Ph.D., a professor of medical oncology at Université Paris-Saclay,&nbsp;and head of the Department of Oncology at Gustave Roussy, Villejuif, France. "This approval provides eligible patients and their doctors a new way to tailor treatment plans for each individual's needs and to improve the efficiency with which nivolumab can be administered&nbsp;from a patient perspective as well as in the organization of our healthcare resources."
The approval by the EC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

Government

Regulations

Bristol Myers Squibb Gets EU OK for First-of-Its-Kind 5-Minute Injection Cancer Drug Opdivo SC

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com&amp;esheet=54259291&amp;newsitemid=20250522073240&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=af9d83007f4ec9c0208de4cae58918fc">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) today announced the presentation of data across its oncology portfolio and pipeline at the 2025 American Society of Clinical Oncology (ASCO&#xAE;) Annual Meeting to be held May 30-June 3 in Chicago, Illinois. Data from more than 80 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning more than 20 cancer types.

Bristol Myers Squibb To Present Data Highlighting Differentiated Research Platform Of Oncology Treatments And Innovative Research Pipeline At ASCO 2025

This whale alert can help traders discover the next big trading opportunities.
Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner.
Traders will search for circumstances when the market estimation of an option diverges heavily from its normal worth. High amounts of trading activity could push option prices to exaggerated or underestimated levels. 
Here's the list of options activity happening in today's session: 
<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>BSX</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>06/20/25</td>
<td>$90.00</td>
<td>$286.6K</td>
<td>20.5K</td>
<td>19.1K</td>
</tr>
<tr>
<td>UNH</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>05/30/25</td>
<td>$320.00</td>
<td>$82.5K</td>
<td>2.3K</td>
<td>5.2K</td>
</tr>
<tr>
<td>HUM</td>
<td>CALL</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>05/30/25</td>
<td>$290.00</td>
<td>$330.7K</td>
<td>64</td>
<td>1.3K</td>
</tr>
<tr>
<td>AKRO</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$50.00</td>
<td>$81.0K</td>
<td>573</td>
<td>292</td>
</tr>
<tr>
<td>OCUL</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>12/19/25</td>
<td>$10.00</td>
<td>$32.5K</td>
<td>60</td>
<td>190</td>
</tr>
<tr>
<td>LLY</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>06/27/25</td>
<td>$810.00</td>
<td>$35.5K</td>
<td>12</td>
<td>169</td>
</tr>
<tr>
<td>BMY</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>03/20/26</td>
<td>$45.00</td>
<td>$43.0K</td>
<td>3.5K</td>
<td>113</td>
</tr>
<tr>
<td>HIMS</td>
<td>CALL</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>08/15/25</td>
<td>$60.00</td>
<td>$35.0K</td>
<td>2.4K</td>
<td>85</td>
</tr>
<tr>
<td>ABBV</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>08/15/25</td>
<td>$175.00</td>
<td>$93.8K</td>
<td>384</td>
<td>59</td>
</tr>
<tr>
<td>NVO</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>01/15/27</td>
<td>$40.00</td>
<td>$29.9K</td>
<td>776</td>
<td>58</td>
</tr>
</tbody>
</table>

<h2>Explanation</h2>
These itemized elaborations have been created using the accompanying table. 
• For BSX (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BSX#NYSE">BSX</a>), we notice a put option trade that happens to be bearish, expiring in 31 day(s) on June 20, 2025. This event was a transfer of 11467 contract(s) at a $90.00 strike. The total cost received by the writing party (or parties) was $286.6K, with a price of $25.0 per contract. There were 20532 open contracts at this strike prior to today, and today 19153 contract(s) were bought and sold. 
• Regarding UNH (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>), we observe a call option trade with bearish sentiment. It expires in 10 day(s) on May 30, 2025. Parties traded 60 contract(s) at a $320.00 strike. The total cost received by the writing party (or parties) was $82.5K, with a price of $1375.0 per contract. There were 2315 open contracts at this strike prior to today, and today 5276 contract(s) were bought and sold. 
• Regarding HUM (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HUM#NYSE">HUM</a>), we observe a call option trade with bullish sentiment. It expires in 10 day(s) on May 30, 2025. Parties traded 1350 contract(s) at a $290.00 strike. The total cost received by the writing party (or parties) was $330.7K, with a price of $245.0 per contract. There were 64 open contracts at this strike prior to today, and today 1371 contract(s) were bought and sold. 
• Regarding AKRO (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AKRO#NASDAQ">AKRO</a>), we observe a call option sweep with bullish sentiment. It expires in 31 day(s) on June 20, 2025. Parties traded 270 contract(s) at a $50.00 strike. This particular call needed to be split into 11 different trades to become filled. The total cost received by the writing party (or parties) was $81.0K, with a price of $300.0 per contract. There were 573 open contracts at this strike prior to today, and today 292 contract(s) were bought and sold. 
• Regarding OCUL (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OCUL#NASDAQ">OCUL</a>), we observe a put option trade with bearish sentiment. It expires in 213 day(s) on December 19, 2025. Parties traded 100 contract(s) at a $10.00 strike. The total cost received by the writing party (or parties) was $32.5K, with a price of $325.0 per contract. There were 60 open contracts at this strike prior to today, and today 190 contract(s) were bought and sold. 
• For LLY (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), we notice a call option trade that happens to be bearish, expiring in 38 day(s) on June 27, 2025. This event was a transfer of 24 contract(s) at a $810.00 strike. The total cost received by the writing party (or parties) was $35.5K, with a price of $1480.0 per contract. There were 12 open contracts at this strike prior to today, and today 169 contract(s) were bought and sold. 
• Regarding BMY (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), we observe a put option trade with bearish sentiment. It expires in 304 day(s) on March 20, 2026. Parties traded 104 contract(s) at a $45.00 strike. The total cost received by the writing party (or parties) was $43.0K, with a price of $414.0 per contract. There were 3563 open contracts at this strike prior to today, and today 113 contract(s) were bought and sold. 
• Regarding HIMS (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HIMS#NYSE">HIMS</a>), we observe a call option trade with neutral sentiment. It expires in 87 day(s) on August 15, 2025. Parties traded 25 contract(s) at a $60.00 strike. The total cost received by the writing party (or parties) was $35.0K, with a price of $1400.0 per contract. There were 2475 open contracts at this strike prior to today, and today 85 contract(s) were bought and sold. 
• Regarding ABBV (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>), we observe a call option sweep with bearish sentiment. It expires in 87 day(s) on August 15, 2025. Parties traded 59 contract(s) at a $175.00 strike. This particular call needed to be split into 5 different trades to become filled. The total cost received by the writing party (or parties) was $93.8K, with a price of $1590.0 per contract. There were 384 open contracts at this strike prior to today, and today 59 contract(s) were bought and sold. 
• For NVO (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), we notice a call option sweep that happens to be bullish, expiring in 605 day(s) on January 15, 2027. This event was a transfer of 9 contract(s) at a $40.00 strike. This particular call needed to be split into 9 different trades to become filled. The total cost received by the writing party (or parties) was $29.9K, with a price of $3330.0 per contract. There were 776 open contracts at this strike prior to today, and today 58 contract(s) were bought and sold. 
Options Alert Terminology 
 - Call Contracts: The right to buy shares as indicated in the contract. 
 - Put Contracts: The right to sell shares as indicated in the contract. 
 - Expiration Date: When the contract expires. One must act on the contract by this date if one wants to use it. 
 - Premium/Option Price: The price of the contract. 
For more information, visit our <a href="https://pro.benzinga.com/blog/how-to-understand-option-alerts/">Guide to Understanding Options Alerts</a> or read <a href="https://www.benzinga.com/markets/options">more news on unusual options activity</a>. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Options

AKRO

Hims & Hers Health, Inc. Class A Common Stock

HIMS

OCUL

10 Health Care Stocks With Whale Alerts In Today's Session

On the surface, outside circumstances don't appear favorable for pharmaceutical giant Bristol-Myers Squibb Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), which finds itself caught in a political wake. Earlier this week, President Donald Trump signed an executive order aimed at <a href="https://www.benzinga.com/general/health-care/25/05/45341590/trumps-drug-pricing-executive-order-could-rattle-pharma-stocksprice-cuts-up-to-80">lowering prescription drug prices</a>, posing significant challenges for pharmaceutical companies. Still, with the bad news baked into BMY stock, a potential for a bounce back isn't out of the question.
In a Truth Social post on Sunday, Trump stated that the executive order will implement a "Most Favored Nations" policy. Essentially, the directive will prevent pharmaceutical firms from charging disparate prices across different markets. In theory, then, U.S. consumers will pay no more than what patients from other countries will be charged for the same drug.
Fundamentally, the move will likely have the biggest impact on Medicare Part B drugs, a category that largely consists of outpatient prescriptions and biologicals. Further, the prices of these drugs are directly managed by the Centers for Medicare &amp; Medicaid Services (CMS).
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As it relates to Bristol-Myers Squibb, its cancer drug Opdivo falls under the Part B categorization. This fact puts BMY stock at risk since Trump is seeking to reduce prescription drug prices by "30% to 80%." Setting aside the <a href="https://www.msnbc.com/opinion/msnbc-opinion/trump-drug-price-executive-order-big-pharma-rcna206289">legality</a> of the proposal, a discount of that magnitude would force a reevaluation of the business.
Nevertheless, the shock to the system may present an opportunity for contrarian speculators.
<h2 class="wp-block-heading">A Rare Quantitative Signal May Bode Well for BMY Stock</h2>
Although BMY stock represents one of the stalwarts of the broader healthcare ecosystem, it hasn't always been the most productive security for investors. For example, in the past 52 weeks, shares have only gained less than 6%. And in the trailing five years, BMY is down more than 27%.
Part of the challenge centers on the choppiness of the security. Since January 2019, BMY stock barely demonstrates an upward bias. Specifically, the odds that a long position held for a one-week period will be profitable are only 50.6%. That's not a reliable edge by any means.
However, the long-side probability is not 50.6% across all sentiment regimes. In other words, certain fear and greed cycles may feature probabilities that are much more favorable than the baseline.
As circumstances stand right now, BMY stock is charting a "2-8" sequence: two up weeks mixed with eight down weeks, with a negative trajectory across the period. This bearish-dominated sequence has only materialized 18 times in the past decade. Notably, though, in 61.11% of cases, the following week's price action has resulted in upside, with a median return of 1.19%.
<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="576" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/16152538/BMY-stock-10wk-forecast-1024x576.jpg" alt="" class="wp-image-918453" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/16152538/BMY-stock-10wk-forecast-1024x576.jpg 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/16152538/BMY-stock-10wk-forecast-300x169.jpg 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/16152538/BMY-stock-10wk-forecast-768x432.jpg 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/16152538/BMY-stock-10wk-forecast.jpg 1280w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">Image by author</figcaption></figure>
Assuming the bulls continue to control the market, a move toward $48 over the next three weeks would be quite reasonable. On the other hand, should the bears assume the wheel, a gradual descent to around $45 may be the downside target.
<h2 class="wp-block-heading">Scalping a Big Payout from a Small Move</h2>
In the open market, BMY stock could deliver a return of about 3%, which isn't anything to write home about. However, it's a different story when traders take advantage of the unique geometry of multi-leg options strategies.
Take, for example, the 47/48 bull call spread expiring June 6. This transaction involves buying the $47 call and simultaneously selling the $48 call. With the credit received from the short call partially offsetting the debit paid for the long call, the net debit paid for this trade comes out to $47. Should BMY stock rise through the short strike price of $48 at expiration, the maximum reward is $53, a payout of nearly 113%.
To be clear, both legs of the 47/48 call spread are out the money, which means that if BMY stock doesn't move at all from here, the entire net debit is at risk of loss. On the other hand, the leverage that options provide allows relatively small moves to translate to big gains.
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Image: Shutterstock

Options Corner: Political Turmoil Sets Up A Contrarian Call Spread For Bristol-Myers Squibb

On May 12, President Donald Trump followed through on a campaign promise by signing an Executive Order (EO) mandating that pharmaceutical companies lower their prescription drug prices in the US to those seen abroad.
At a media event, Trump told reporters he was aiming for price cuts of between 59% and 90% and gave drug companies 30 days to play ball.
Wall Street digested the news, and while major biopharma stocks saw share prices drop the day the EO was announced, most industry stocks rebounded.&nbsp;
Here are three pharma stocks that won&#8217;t just rebound, but are poised to soar because of Trump&#8217;s executive order.
<h1 class="wp-block-heading">Team Trump on Solid Ground?</h1>
Nobody&#8217;s denying that US drug prices are out of whack. A 2024 RAND Corporation study concluded US drug prices were approximately three times higher than those in 33 other developed countries.
Presidents have full power to order such a price cut from a private industry, at least in part.
&#8220;That&#8217;s especially the case in sectors like healthcare where government programs like Medicare are massive buyers,&#8221; said Lou Carter, founder and CEO at the Best Practice Institute in Palm Beach Gardens, Fla. &#8220;Policy isn&#8217;t just about law—it&#8217;s about leverage. This EO uses the weight of public programs to force pricing accountability, and that&#8217;s smart business when you&#8217;re managing taxpayer funds.&#8221;
Congress and the courts can try to stop the EO in its tracks, but success on that front is unlikely.&nbsp;
&#8220;Politically, it&#8217;s tough to argue against lower drug prices,&#8221; Carter said. &#8220;Even if pharma lobbies hard, most lawmakers know it&#8217;s political suicide to oppose something that helps seniors afford insulin. If this goes to court, it&#8217;ll hinge on procedural questions—not on whether the move is popular or right.&#8221;
<h1 class="wp-block-heading">Bigger Drug Makers are Hardest Hit</h1>
Given the size and scope of the EO, it&#8217;s no surprise that the more substantial drug companies may find themselves in financial trouble.&nbsp;
&#8220;Large-cap biotech and specialty pharma companies with heavy Medicare exposure like Amgen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) or Regeneron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) could be hit hardest,&#8221; said Dr. Will Soliman, Founder and CEO of the New York City-based Accreditation Council for Medical Affairs. &#8220;They rely on high-margin (Medicare) Part B drugs.&#8221;
Vertical-oriented drug makers could also feel the heat from the EO.&nbsp;
&#8220;Specialized oncology manufacturers like Bristol Myers Squibb (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) have greater exposure than diversified pharmaceutical companies with broader portfolio ranges,&#8221; said Seann Malloy, founder and managing partner of Malloy Law Offices in Bethesda, Md. &#8220;Small to mid-cap biotechnology companies with early commercial products often fall outside immediate impact zones due to limited Medicare utilization and existing price protection provisions. &#8220;
&#8220;The executive order&#8217;s key element mandates that Medicare&#8217;s prescription drug payments align with the lowest prices in other developed countries, essentially using international reference pricing,&#8221; Malloy said. &#8220;While some demonstration projects will start within 30 days, full implementation across all provisions will take longer, likely 6-12 months, due to necessary regulatory development. &#8220;
Timing could play a big role in determining how much of an impact the EO will have on biotech drug stocks, if any.
Initially, the order focuses on physician-administered drugs under Medicare Part B but may later include retail prescriptions under Part D. &#8220;This staged implementation means the immediate and long-term market effects will differ, a point often missed by investors,&#8221; Malloy noted. &#8220;Despite initial impressions of swift price changes, significant revenue impacts will likely be delayed by extensive regulatory procedures.&#8221;
Additionally, overseas drug providers may face stiff headwinds from the Trump drug price directive.
&#8220;International manufacturers are most vulnerable,&#8221; said Javier Palomarez, founder and CEO of the United States Hispanic Business Council. &#8220;Many of them ship to the United States because of the return on investment &#8211; eroding that return dampens the incentive and ability to ship medicines across the world, which could lead to total loss of US market access for some companies.&#8221;
<h1 class="wp-block-heading">Three Drug Stocks That Bear Watching Over the Next 30 Days</h1>
Biotech investors looking to leverage the Trump EO should understand Trump&#8217;s intention to &#8220;cut out the middleman,&#8221; as he said in his May 12 press event. This translates to good news for actual drug manufacturers and not-so-good news for so-called pharmacy-benefit managers.
PBM&#8217;s act as intermediaries between health insurance companies, big employers, drug manufacturers, insurers, and patients. While they don&#8217;t produce prescription drugs, they handle the more mundane side of the drug business, like claims processing and negotiating prescription drug prices.
The big drug producers have historically blamed the PBMs for sky-high drug prices and would likely back any initiative that expands the direct-to-consumer drug marketplace. In that scenario, no insurers are needed, as drug consumers could deal directly with drug manufacturers to buy the medicines they need, presumably at a more affordable price.
Investors in that marketplace would want large drug makers, and big PBMs would not. These three drug stocks stand out on the plus side.
<h2 class="wp-block-heading">Eli Lilly</h2>
Drug manufacturing giant Eli Lilly (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) is priced high at $730 per share, but it&#8217;s a stock that would likely prosper in a direct-to-consumer prescription drug marketplace. The stock is off by 5.0% year-to-date, but 26 Wall Street analysts who track LLY give it a top rating. The company&#8217;s recent earnings per share are off the charts, with an upward spike of 106% in EPS in 2024 and an estimated 68% in 2025. The stock is off 20% compared to recent highs, which could mean a nice discount for a drug industry stalwart.
<h2 class="wp-block-heading">Novo Nordisk</h2>
Novo Nordisk (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) has experienced market woes that preceded the Trump E/O, as competitors continue to chew into market share in the lucrative weight loss drug market. Particularly damaging was a recent study that concluded patients taking Eli Lilly&#8217;s Zepbound were losing weight faster than with Novo&#8217;s Wegovy. That&#8217;s one big reason Novo Nordisk has seen its share price fall by 50% over the past year. Yet the stock is in rebound mode right now, up 13.9% over the past month. A $2.2 billion deal between Novo and Septerna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SEPN#NASDAQ">SEPN</a>) to develop weight loss pills is seen as a big step by analysts and big names like Goldman Sachs and JP Morgan are sticking to their buy calls on the stock. Meanwhile, a larger group of industry analysts is out with a consensus 50% share price upside from current levels.
<h2 class="wp-block-heading">AbbVie</h2>
AbbVie (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) is a genuine cash flow producer that seems immune to any political interference from Washington, D.C. The drug manufacturer has a diverse set of popular prescription drugs, like Botox, Humira, Rinvoq, and Skyrizi. The stock only fell by a paltry 1% on the E news this week, and is up 5% over the past month. It also comes with a healthy 3.6% dividend for income-minded investors, a robust drug pipeline in play, and a brand new regulatory &#8220;green light&#8221; for its lung cancer drug Emrelis, supporting the rationale that ABBV shares should continue to climb in 2025.
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Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced on Wednesday that it will invest at least $20 billion in the <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">U.S. through 2030</a>.
Research and development, plus U.S. manufacturing, will receive the bulk of the spending.
The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help <a href="https://www.benzinga.com/pressreleases/25/05/n45414947/sanofi-to-invest-at-least-20-billion-in-the-us-through-2030-growing-investments-in-science-and-exp" target="_blank" rel="noreferrer noopener">enhance the U.S. supply chain</a>.
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Sanofi has 13,000 US-based employees, according to CEO Paul Hudson.
&#8220;Our expected investments in the US will be substantial and will help ensure the production of key medicines in the U.S.,&#8221; he added.
Sanofi also expects to partner with other domestic manufacturers to help ensure the production of medicines in the U.S.  
Earlier in May, U.S. President&nbsp;Donald Trump's&nbsp;signed an executive order to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on&nbsp;<a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">imported medicines loom</a>.
The White House wants facilities to come on board at a faster rate. It <a href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">estimates</a> that it can currently take five to 10 years to build new pharmaceutical manufacturing capacity, which it calls "unacceptable from a national-security standpoint.&#8221;
It&#8217;s not just Sanofi. <a href="https://www.benzinga.com/25/05/45234032/fda-expands-surprise-inspections-at-foreign-drug-and-food-facilities-targets-double-standards-in-overseas-manufacturing-oversight" target="_blank" rel="noreferrer noopener">Amid tariff uncertainty</a>, many drug companies are investing to boost production within the U.S.:
<ul class="wp-block-list">
<li>Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) doubled&nbsp;<a href="https://www.benzinga.com/general/biotech/25/02/43982604/eli-lilly-doubles-capital-spending-on-us-drug-manufacturing-with-50-billion-target" target="_blank" rel="noreferrer noopener">domestic medicine production</a>.</li>
<li>Thermo Fisher Scientific Inc.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) announced it would invest an additional $2 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/general/health-care/25/04/44995428/thermo-fisher-doubles-down-on-us-manufacturing-in-2b-expansion-plan" target="_blank" rel="noreferrer noopener">the next four years</a>.</li>
<li>Medtech firm&nbsp;Becton, Dickinson, and Company&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) also announced its intention to invest&nbsp;$2.5 billion&nbsp;in U.S. manufacturing capacity&nbsp;<a href="https://www.benzinga.com/general/health-care/25/05/45140102/potential-tariff-bites-into-becton-dickinson-2025-profit-outlook-company-will-invest-2-5-billion-to-boost-us-manufacturing" target="_blank" rel="noreferrer noopener">over the next 5 years</a>.</li>
<li>Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)  seeks to nearly double its manufacturing capacity through a new agreement with <a href="https://www.benzinga.com/general/biotech/25/04/44931246/regeneron-partners-with-japan-based-fujifilm-to-bolster-us-manufacturing-capacity-via-3-billion-deal" target="_blank" rel="noreferrer noopener">FUJIFILM Diosynth Biotechnologies</a>.</li>
<li>Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) unveiled a $23 billion investment plan to expand in the U.S. <a href="https://www.benzinga.com/general/biotech/25/04/44761201/novartis-commits-23-billion-to-expand-us-manufacturing-over-five-years-despite-tariffs-uncertaint" target="_blank" rel="noreferrer noopener">over the next five years</a>.</li>
<li>Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) plans to invest more than <a href="https://www.benzinga.com/markets/equities/25/03/44433978/johnson-johnson-to-invest-55-billion-in-us-to-boost-manufacturing-drug-discovery" target="_blank" rel="noreferrer noopener">$55 billion in the U.S. over the next four years</a>.</li>
<li>Roche Holdings AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)&nbsp;announced that it will invest $50 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/topic/pharmaceuticals" target="_blank" rel="noreferrer noopener">the next five years.</a></li>
<li>Bristol-Myers Squibb &amp; Co.'s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>)&nbsp;Christopher Boerner, chair and chief executive officer,&nbsp;<a href="https://www.statnews.com/2025/05/05/bristol-myers-squibb-pharmaceutical-policy-us-trump-administration-innovation-tariffs/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">shared</a>&nbsp;plans to invest $40 billion in U.S. R&amp;D, technology, and manufacturing over the next five years in an op-ed published by Statnews.</li>
</ul>
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) is one pharma company that did not highlight investments in new manufacturing plants. The company noted that they already have significant capacity and flexibility to manufacture <a href="https://www.benzinga.com/general/biotech/25/04/45118145/pfizer-ceo-albert-bourla-emphasizes-national-security-in-us-drug-manufacturing" target="_blank" rel="noreferrer noopener">products in the U.S</a>.
Price Action: Sanofi stock is down 1.53% at $49.20 at the last check on Wednesday.
Read Next:
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<li><a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs" target="_blank" rel="noreferrer noopener">Novo Nordisk Inks $2.2 Billion Deal With Septerna To Develop Oral Weight Loss And Diabetes Drugs</a></li>
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