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Roche Holding (OTC:RHHBY) 株価情報, 空売り情報

Roche Holding

ROCHE HLDG LTD SPONS

Roche is a Swiss biopharmaceutical and diagnostic company. The firm's bestselling pharmaceutical products include a variety of oncology therapies from acquired partner Genentech, and its diagnostics group was bolstered by the acquisition of Ventana in 2008. Oncology products account for 50% of pharmaceutical sales, and centralized and point-of-care diagnostics for more than half of diagnostic-related sales.

ROCHE HOLDING LTD S/ADR by Roche Holding Ltd

Roche Holding AG

<ul>
<li>The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone –</li>
<li>The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis –</li>
<li>New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine</li>
</ul>

News

RHHBF

RHHBY

Reported Saturday, Genentech's Itovebi-Based Regimen Cuts Risk Of Death By Over 30% In PIK3CA-Mutated HR-Positive, HER2-Negative Advanced Breast Cancer, Phase III INAVO120 Data Show

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) on Friday announced new 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low disease activity levels for up to two years.
The latest <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-05-30" rel="noreferrer noopener">results</a> for this investigational Bruton&#8217;s tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.
Ninety-nine patients entered the OLE and 93 remained in the OLE after 96 weeks.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45393806/ten-year-data-from-roches-breast-cancer-trial-shows-perjeta-based-regimen-cuts-death-risk-by-17" rel="noreferrer noopener">Ten-Year Data From Roche&#8217;s Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%</a>
During the OLE period, patients treated with fenebrutinib for up to 96 weeks had a low annualised relapse rate (ARR) of 0.06, and during this time there was no disability progression, as measured by the Expanded Disability Status Scale (EDSS).
MRI scans showed that fenebrutinib treatment suppressed disease activity in the brain. At 96 weeks zero new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation, were detected.
In the treatment group that switched from placebo to fenebrutinib in the OLE, the annualized rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12-week double-blind period to 0.34 by 96 weeks.
The safety profile of fenebrutinib in the OLE was consistent with previously reported data, with no new safety concerns identified at 96 weeks.
During the OLE, one patient experienced asymptomatic alanine aminotransferase elevation at OLE week 4, after 16 weeks on treatment, which resolved with treatment discontinuation.
Three Phase 3 trials are ongoing, including the FENhance 1 and 2 trials in RMS and the FENtrepid trial in primary progressive multiple sclerosis (PPMS). The first data from these studies are expected at the end of 2025.
In April, Roche announced it would invest $50 billion in the U.S. over&nbsp;the <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44934942/roche-plans-50-billion-us-investment-over-5-years-with-12000-new-jobs" rel="noreferrer noopener">next five years</a>.
These investments further strengthen Roche&#8217;s already significant U.S. footprint, which includes 13 manufacturing and 15 R&amp;D sites across the Pharmaceutical and Diagnostics Divisions.
The investment is expected to&nbsp;<a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-04-22?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" rel="noreferrer noopener">create</a> over 12,000 new jobs, including nearly 6,500 construction jobs and 1,000 jobs at new and expanded facilities.
Price Action: RHHBY stock is trading higher by 1.83% to $40.25 at last check Friday.
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</ul>
Photo by OleksSH via Shutterstock

Health Care

Roche's Multiple Sclerosis Drug Shows Low Disease Activity Over Two Years

<ul>
<li>- Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment -</li>
<li>- Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end -</li>
</ul>

Roche's Genentech Reports Long-Term Data Showing Fenebrutinib Prevents Active Brain Lesions And MS Disability Progression Over 2 Years

<ul>
<li>Updated data from the pivotal Phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant</li>
<li>89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment</li>
<li>Timely initiation of effective therapy at relapse or after initial therapy failure is critical for this aggressive, life-threatening disease&nbsp;</li>
<li>Results demonstrate potential of the Columvi combination as a much-needed, off-the-shelf and fixed-duration treatment option&nbsp;</li>
</ul>

Roche's Genentech Highlights Two-Year STARGLO Data: Columvi Plus Chemotherapy Delivers 40% Overall Survival Benefit In Transplant-Ineligible Relapsed Or Refractory DLBCL Patients

Contracts

Watching Roche; Reuters Reports Statement From Co Stating It Plans To Invest Up To 4 Billion Pesos In Clinical Investigation In Mexico In Next 5-Years

<a href="https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease">https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease</a>.

Biotech

General

ACIU

ANVS

BIIB

DNLI

PRTA

SAVA

'FDA Clears First Blood Test Used In Diagnosing Alzheimer's Disease; New Test Provides Less Invasive Option, Reduces Reliance On Pet Scans And Increases Diagnosis Accessibility' - FDA

Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) on Thursday said the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), met its primary endpoint of progression-free survival (PFS) for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">and in all comers</a>.
The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45418609/fda-approves-mercks-kidney-cancer-drug-for-rare-type-of-neuroendocrine-tumors" rel="noreferrer noopener">FDA Approves Merck&#8217;s Kidney Cancer Drug For Rare Type Of Neuroendocrine Tumors</a>
The study is evaluating Keytruda&nbsp;(pembrolizumab), Merck&#8217;s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Avastin (bevacizumab) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/b45431872/merck-announces-phase-3-keynote-b96-trial-met-primary-endpoint-of-progression-free-survival-pfs-in" rel="noreferrer noopener">for these patients</a>.
The trial continues, and OS for the full study population will be evaluated at a future analysis.
The Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy with or without bevacizumab.
The study also showed a statistically significant and clinically meaningful improvement in OS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) compared to placebo plus chemotherapy with or without bevacizumab.
&#8220;This marks the first time a KEYTRUDA-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer,&#8221; said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
Keytruda is not approved for ovarian cancer.
Lynparza (olaparib), jointly developed by AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) and Merck, has three approved ovarian <a href="https://www.benzinga.com/24/12/42393128/merck-reveals-mixed-data-from-keytrudalynparza-regime-in-ovarian-cancer" target="_blank" rel="noreferrer noopener">cancer indications in the U.S</a>.
In October, Merck&nbsp;announced that the Phase 3 KEYNOTE-689 trial of Keytruda, as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma, met its primary endpoint of&nbsp;<a target="_blank" href="https://www.benzinga.com/general/health-care/24/10/41230591/merck-touts-phase-3-success-for-20b-cancer-drug-keytruda-in-untreated-head-and-neck-cancer-pa" rel="noreferrer noopener">event-free survival (EFS)</a>.
Price Action: MRK stock is
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</ul>
Image: Shutterstock

Large Cap

Merck Data Shows Positive Outcomes For Ovarian Cancer Patients Treated With Keytruda

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>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44981281/french-drugmaker-sanofi-clocks-20-q1-profit-growth-forecasts-strong-rebound-in-annual-profit" rel="noreferrer noopener">French Drugmaker Sanofi Clocks 20% Q1 Profit Growth, Forecasts Strong Rebound In Annual Profit</a>
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.
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</ul>
Image: Shutterstock

Movers

Trading Ideas

REGN

Sanofi To Navigate Tariff Impact With $20 Billion In Spending Through 2030

The U.S. Food and Drug Administration (FDA) granted accelerated approval to AbbVie&nbsp;Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) Emrelis&nbsp;(telisotuzumab vedotin-tllv) for adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">received a prior systemic therapy</a>.
High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45415840/u-s-fda-approves-emrelis-telisotuzumab-vedotin-tllv-for-adults-with-previously-treated-advanced-no" rel="noreferrer noopener">by an FDA-approved test</a>.
This indication is approved based on overall response rate (ORR) and duration of response (DOR).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s), the company said in a statement on Wednesday.
Also Read: <a target="_blank" href="https://www.benzinga.com//node/45079377" rel="noreferrer noopener">AbbVie Scores FDA Approval For Its Blockbuster Drug Rinvoq To Treat Type Of Arthritis</a>
Emrelis is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population.&nbsp;
ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent &#8216;payload&#8217; directly to the biomarker-expressing cell.
Data from the Phase 2 LUMINOSITY study, designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations, support the FDA&#8217;s accelerated approval.
Findings from the study showed patients with high c-Met protein overexpression (n=84) who received Emrelis demonstrated a 35% Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months.
In&nbsp;December 2021, the FDA granted EMRELIS&nbsp;<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4408820-1&amp;h=2952437730&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4264002-1%26h%3D3470428670%26u%3Dhttps%253A%252F%252Fnews.abbvie.com%252F2022-01-04-AbbVie-Announces-U-S-FDA-Granted-Breakthrough-Therapy-Designation-BTD-to-Telisotuzumab-Vedotin-Teliso-V-for-Previously-Treated-Non-Small-Cell-Lung-Cancer%26a%3DBreakthrough%2BTherapy%2BDesignation%2Bby%2Bthe%2BFDA&amp;a=Breakthrough+Therapy+Designation" rel="noreferrer noopener">Breakthrough Therapy Designation</a> (BTD) based on Phase 2 LUMINOSITY study data.
Emrelis is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study&nbsp;<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4408820-1&amp;h=741691694&amp;u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04928846&amp;a=TeliMET+NSCLC-01" rel="noreferrer noopener">TeliMET NSCLC-01</a>.
Enrollment in the study is underway and continues across global clinical trial sites.
The FDA has also approved Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) VENTANA&nbsp;MET (SP44) RxDx Assay, the only IHC companion diagnostic identifying patients eligible for Emrelis treatment.
On Wednesday, AbbVie&nbsp;and ADARx Pharmaceuticals announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45405186/abbvie-and-adarx-pharmaceuticals-announce-collaboration-and-license-option-agreement-to-develop-ne" rel="noreferrer noopener">immunology, and oncology</a>.
siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates gene expression. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.
ADARx will receive a&nbsp;$335 million&nbsp;upfront payment and is eligible to receive several billion dollars in additional contingent payments, including option-related fees, milestone payments, and royalties.
Price Action: ABBV stock is down 5.32% at $177.96&nbsp;at the last check on Wednesday.
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Photo via Shutterstock

ABBV

FDA Fast-Tracks AbbVie's New Lung Cancer Therapy Emrelis For Tough Lung Cancer Cases

<a href="https://www.bloomberg.com/news/articles/2025-05-14/roche-warns-us-investments-at-risk-from-trump-drug-price-plans" title="https://www.bloomberg.com/news/articles/2025-05-14/roche-warns-us-investments-at-risk-from-trump-drug-price-plans">https://www.bloomberg.com/news/articles/2025-05-14/roche-warns-us-investments-at-risk-from-trump-drug-price-plans</a>

'Roche Warns US Investments at Risk From Trump Drug Price Plans' - Bloomberg News

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) on Tuesday released statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">early-stage breast cancer</a>.
After ten years, the risk of death was reduced by 17% for people treated with Perjeta (pertuzumab), Herceptin (trastuzumab), and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/04/44934942/roche-plans-50-billion-us-investment-over-5-years-with-12000-new-jobs" target="_blank" rel="noreferrer noopener">Roche Plans $50 Billion US Investment Over 5 Years With 12,000 New Jobs</a>
After ten years, <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-05-13" rel="noreferrer noopener">results</a> show:
<ul class="wp-block-list">
<li>91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, p-value=0.044).</li>
<li>A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79).</li>
<li>The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79), strengthening results from earlier APHINITY analyses. No benefit was seen in the node-negative subgroup.</li>
<li>The safety profile, including cardiac safety, was consistent with previous studies, and no new or unexpected safety signals were identified.</li>
</ul>
Full results will be presented at the 2025 European Society for Medical Oncology Breast Cancer Congress.
In April, Sarepta Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) and&nbsp;Roche temporarily&nbsp;halted&nbsp;several clinical studies for Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with <a target="_blank" href="https://www.benzinga.com/25/04/44634689/sareptaroche-suspend-elevidys-gene-therapy-trials-in-europe-after-patient-death" rel="noreferrer noopener">Duchenne muscular dystrophy</a>.
The company reported a patient death following treatment with Elevidys, having suffered&nbsp;<a target="_blank" href="https://www.benzinga.com/25/03/44376919/sarepta-therapeutics-reports-patient-death-post-elevidys-gene-therapy-treatment-stock-plunges" rel="noreferrer noopener">acute liver failure</a>.
In April, Roche&#8217;s MUSETTE Phase 3 trial of a high dose of Ocrevus (ocrelizumab) intravenous infusion for relapsing multiple sclerosis did not meet its primary endpoint in showing additional benefit in slowing disability progression compared with the currently approved <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44613949/why-is-pharma-giant-roche-stock-trading-lower-on-wednesday" rel="noreferrer noopener">Ocrevus IV 600 mg dose</a>.
Price Action: RHHBY stock is trading at $38.34 at the last check on Tuesday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/large-cap/25/05/45383468/earnings-just-put-dan-loebs-bets-to-the-testheres-what-held-up" target="_blank" rel="noreferrer noopener">Earnings Just Put Dan Loeb&#8217;s Bets To The Test — Here&#8217;s What Held Up</a></li>
</ul>
Photo by OleksSH via Shutterstock

SRPT

Ten-Year Data From Roche's Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%

<ul>
<li>An investment of up to $550 million by 2030 will establish the Indianapolis site as a hub for manufacturing of Roche's continuous glucose monitoring solution.</li>
<li>Expansion will create hundreds of jobs while also enhancing U.S. production capabilities.</li>
<li>Increased access to diabetes management tools will help improve health outcomes for patients in the U.S. and globally.</li>
</ul>
INDIANAPOLIS, May 12, 2025 /PRNewswire/ -- Roche ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>) announced today it plans to invest up to $550 million in its Diagnostics site in Indianapolis by 2030. The site will become a major hub for the manufacturing of&nbsp;Roche's continuous glucose monitoring (CGM) systems – marking a new milestone in Roche's long history of revolutionizing healthcare across the globe.

Roche Plans To Invest Up To $550M In Its Diagnostics Site In Indianapolis By 2030

The Founder, CEO, and CIO of Ark Invest, Cathie Wood, has highlighted the rising applications of artificial intelligence and how it is poised to impact not only autonomous taxi networks and humanoid robots but also the health care space.
What Happened: According to ARK's proprietary Multiomics Flywheel, Wood highlighted in her recent X post that autonomous taxi networks and humanoid robots are likely to be the largest AI applications during the next five and ten years, respectively; however, &#8220;health care is likely to be the most profound.&#8221;
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">While autonomous taxi networks and humanoid robots are likely to be the largest <a href="https://twitter.com/hashtag/AI?src=hash&amp;ref_src=twsrc%5Etfw">#AI</a> applications during the next five and ten years, respectively, health care is likely to be the most profound. Thank you <a href="https://twitter.com/NMDespotARK?ref_src=twsrc%5Etfw">@NMDespotARK</a> for thought leadership in the multiomics space! <a href="https://t.co/C33JfypivU">https://t.co/C33JfypivU</a>
&mdash; Cathie Wood (@CathieDWood) <a href="https://twitter.com/CathieDWood/status/1921291392271167893?ref_src=twsrc%5Etfw">May 10, 2025</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
The post shared by Ark&#8217;s multiomics analyst, Nemo M Despot, underscored that &#8220;AI is powering a self-reinforcing loop that accelerates every aspect of multiomics—from generating biological data, to diagnosing diseases, to developing new drugs and cures.&#8221;
Multiomics is a biological analysis approach that integrates data from multiple &#8220;omic&#8221; fields, like genomics, transcriptomics, proteomics, and metabolomics, to gain an understanding of biological systems.
This integrated approach helps researchers uncover complex relationships, identify biomarkers, and ultimately understand the mechanisms behind disease and other biological processes.
He also highlights that companies like Twist Bioscience Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TWST#NASDAQ">TWST</a>), Tempus AI Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TEM#NASDAQ">TEM</a>), 10X Genomics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TXG#NASDAQ">TXG</a>), and Illumina Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ILMN#NASDAQ">ILMN</a>) are developing increasingly powerful tools to sequence and analyze DNA faster and more cost-effectively.
Despot stated that AI-powered molecular diagnostics are transforming early disease detection and enabling precise stratification of individual patient biological profiles.
&#8220;AI leverages data from multiomic tools and diagnostics to design more effective drugs, delivering results with higher success rates more quickly and less expensively,&#8221; he said.
According to him, these next-generation therapies are:
<ul class="wp-block-list">
<li>Approximately 20 times more valuable than standard drugs.</li>
</ul>
<ul class="wp-block-list">
<li>Two to four times more effective than even today's best-in-class precision medicine.</li>
</ul>
<ul class="wp-block-list">
<li>The new cures can address even rare diseases economically.</li>
</ul>
See Also: <a href="https://www.benzinga.com/government/regulations/25/05/45340465/bill-ackman-slams-subsidies-for-contributing-to-37-trillion-national-debt-hails-trumps-drug-price-order">Bill Ackman Slams Subsidies For Contributing To $37 Trillion National Debt, Hails Trump&#8217;s Drug Price Order</a>
Why It Matters: Trump, in a Truth Social post, said that he will <a href="https://www.benzinga.com/general/health-care/25/05/45339399/trump-says-prescription-drug-prices-set-to-drop-by-30-to-80-almost-immediately-thanks-to-most-favored-nation-plan-mark-cuban-urges-president-to-force-tran">sign an executive order</a> on Monday at 9:00 a.m. ET, which will lead the prescription drug and pharmaceutical prices to drop by 30% to 80%.
&#8220;They will rise throughout the World in order to equalize and, for the first time in many years, bring FAIRNESS TO AMERICA! I will be instituting a MOST FAVORED NATION'S POLICY whereby the United States will pay the same price as the Nation that pays the lowest price anywhere in the World,&#8221; he added.
Trump also believes that healthcare costs in the U.S. will be reduced after this move, and it would save &#8220;trillions of dollars.&#8221;
This action by Trump is anticipated to most significantly <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">affect Medicare Part B drugs</a>, primarily outpatient prescriptions and biological products, as their prices are directly controlled by the Centers for Medicare &amp; Medicaid Services (CMS).
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th>Drug Name</th>
<th>Manufacturer(s)</th>
<th>Total Spending</th>
<th>Primary Use</th>
</tr>
</thead>
<tbody>
<tr>
<td>Keytruda</td>
<td>Merck &amp; Co.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) 
<path d="M12 8c1.1 0 2-.9 2-2s-.9-2-2-2-2 .9-2 2 .9 2 2 2zm0 2c-1.1 0-2 .9-2 2s.9 2 2 2 2-.9 2-2-.9-2-2-2zm0 6c-1.1 0-2 .9-2 2s.9 2 2 2 2-.9 2-2-.9-2-2-2z"></path>
<div jsname="ntFePb" class="GRl5yb a8pxAe" style="max-height: 120px; visibility: inherit;"></div>
<div></div>
</td>
<td>$4.0B</td>
<td>Cancer (various types)</td>
</tr>
<tr>
<td>Eylea</td>
<td>Regeneron Pharmaceuticals Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)</td>
<td>$3.4B</td>
<td>Macular degeneration</td>
</tr>
<tr>
<td>Prolia/Xgeva</td>
<td>Amgen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>)</td>
<td>$2.1B</td>
<td>Osteoporosis, bone metastases</td>
</tr>
<tr>
<td>Opdivo</td>
<td>Bristol-Myers Squibb Co.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>)</td>
<td>$2.0B</td>
<td>Cancer (various types)</td>
</tr>
<tr>
<td>Darzalex</td>
<td>Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>)</td>
<td>$1.9B</td>
<td>Multiple myeloma</td>
</tr>
<tr>
<td>Avastin</td>
<td>Roche Holdings AG&nbsp;(OTCQX:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>)</td>
<td>$1.8B</td>
<td>Cancer (various types)</td>
</tr>
</tbody>
</table>
</figure>
Price Action: The SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) and Invesco QQQ Trust ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>), which track the S&amp;P 500 index and Nasdaq 100 index, respectively, rose in premarket on Monday. The SPY was up 2.78% to $564.34, while the QQQ advanced 3.75% to $506.26, according to <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a> data.
On Friday, the SPY was down 0.13% to $564.34, while the QQQ declined 0.066% to $487.97
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/government/regulations/25/05/45341850/economists-warn-of-empty-shelves-if-goods-stop-coming-from-china-amid-falling-inventory-to-sales-ratio-and-potential-tariffs">Economists Warn Of &#8216;Empty Shelves&#8217; If Goods Stop Coming From China Amid Falling Inventory-To-Sales Ratio And Potential Tariffs </a></li>
</ul>
Photo Courtesy: PeopleImages- Yuri A On Shutterstock

Analyst Color

Equities

Government

Market Summary

Regulations

Broad U.S. Equity ETFs

Futures

Markets

Analyst Ratings

ETFs

AMGN

ILMN

TWST

Cathie Wood Says AI Innovation In Healthcare Will Be More 'Profound' Than Autonomous Taxi Networks, Humanoid Robots

On Sunday, President Donald Trump announced on Truth Social that he plans to sign what he called the &#8220;<a href="https://www.benzinga.com/general/health-care/25/05/45339399/trump-says-prescription-drug-prices-set-to-drop-by-30-to-80-almost-immediately-thanks-to-most-favored-nation-plan-mark-cuban-urges-president-to-force-tran">most consequential executive order</a>&#8221; in U.S. history, aimed at lowering prescription drug prices.
What Happened: Trump said the executive order, set to be signed at 9 a.m. Monday, will implement a &#8220;Most Favored Nations&#8221; policy requiring pharmaceutical companies to charge U.S. consumers no more than the lowest price they offer for the same drug in any other country.
See More: <a href="https://www.benzinga.com/25/05/45338985/trump-reportedly-set-to-accept-flying-palace-from-qatar-white-house-says-lavish-gift-of-boeing-jumbo-jet-complies-with-all-applicable-laws">Trump Reportedly Set To Accept &#8216;Flying Palace&#8217; From Qatar, White House Says Lavish Gift Of Boeing Jumbo Jet Complies With &#8216;All Applicable Laws&#8217;</a>
Accusing pharmaceutical companies of overcharging American consumers, sometimes &#8220;five to ten times more&#8221; than patients in other countries, Trump slammed political opponents for enabling the status quo all these years.
Trump says that prescription drug prices will be reduced by &#8220;30% to 80%,&#8221; while rising throughout the world, to equalize and &#8220;bring fairness to America.&#8221;
Why It Matters: This move is expected to have the biggest impact on Medicare Part B drugs, which mainly constitute outpatient prescriptions and biologicals, the prices for which are directly managed by the Centers for Medicare &amp; Medicaid Services (CMS).
<figure class="wp-block-table"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th class="has-text-align-center" data-align="center">Drug Name</th>
<th class="has-text-align-center" data-align="center">Manufacturer(s)</th>
<th class="has-text-align-center" data-align="center">Total Spending</th>
<th class="has-text-align-center" data-align="center">Primary Use</th>
</tr>
</thead>
<tbody>
<tr>
<td class="has-text-align-center" data-align="center">Keytruda</td>
<td class="has-text-align-center" data-align="center">Merck &amp; Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>)</td>
<td class="has-text-align-center" data-align="center">$4.0B</td>
<td class="has-text-align-center" data-align="center">Cancer (various types)</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Eylea</td>
<td class="has-text-align-center" data-align="center">Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) </td>
<td class="has-text-align-center" data-align="center">$3.4B</td>
<td class="has-text-align-center" data-align="center">Macular degeneration</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Prolia/Xgeva</td>
<td class="has-text-align-center" data-align="center">Amgen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>)</td>
<td class="has-text-align-center" data-align="center">$2.1B</td>
<td class="has-text-align-center" data-align="center">Osteoporosis, bone metastases</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Opdivo</td>
<td class="has-text-align-center" data-align="center">Bristol-Myers Squibb Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) </td>
<td class="has-text-align-center" data-align="center">$2.0B</td>
<td class="has-text-align-center" data-align="center">Cancer (various types)</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Darzalex</td>
<td class="has-text-align-center" data-align="center">Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>)</td>
<td class="has-text-align-center" data-align="center">$1.9B</td>
<td class="has-text-align-center" data-align="center">Multiple myeloma</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Avastin</td>
<td class="has-text-align-center" data-align="center">Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)</td>
<td class="has-text-align-center" data-align="center">$1.8B</td>
<td class="has-text-align-center" data-align="center">Cancer (various types)</td>
</tr>
</tbody>
</table>
<figcaption class="wp-element-caption">A breakdown of the top Medicare Part B drugs by spending in 2023, based on the latest data shared by the Centers for Medicare &amp; Medicaid Services (CMS).</figcaption></figure>
These are the stocks that are most likely to be hit by this announcement when markets open on Monday, given their sizable exposure to Medicare, especially being classified as Part B. 
According to a report by the Rand Corporation, a California-based policy think-tank, prescription drug prices in the U.S. are, on average, at least 2.78 times higher than other countries.
While Trump&#8217;s move is being criticized by the likes of crypto enthusiast Ed Krassenstein, calling it &#8220;just another Trump lie,&#8221; saying that an executive order can steer Medicare and Medicaid payments, but <a href="https://www.benzinga.com/general/health-care/25/05/45339399/trump-says-prescription-drug-prices-set-to-drop-by-30-to-80-almost-immediately-thanks-to-most-favored-nation-plan-mark-cuban-urges-president-to-force-tran">cannot force manufacturers</a> to cut prices. 
Others, such as billionaire investor Mark Cuban, have come out in support of the move, saying that it can &#8220;force transparency,&#8221; even if the President cannot force price cuts.
Drug pricing disparities have been a point of contention across the political spectrum. Recently, Novo Nordisk A/S&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) CEO, Lars Fruergaard Jorgensen, <a href="https://www.benzinga.com/general/biotech/24/09/40986953/novo-nordisk-ceo-to-face-senate-scrutiny-over-high-ozempic-and-wegovy-prices-hearing-scheduled-on">faced Senate scrutiny</a> on these vast differences, where he was targeted by Sen.&nbsp;Bernie Sanders&nbsp;(I-Vt.) for the high price of the company&#8217;s diabetes drug, Ozempic. 
<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="135" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/12033045/Screenshot-2025-05-12-at-1.00.28-PM-1024x135.png" alt="" class="wp-image-911404" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/12033045/Screenshot-2025-05-12-at-1.00.28-PM-1024x135.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/12033045/Screenshot-2025-05-12-at-1.00.28-PM-300x40.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/12033045/Screenshot-2025-05-12-at-1.00.28-PM-768x101.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/12033045/Screenshot-2025-05-12-at-1.00.28-PM-1536x202.png 1536w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/12033045/Screenshot-2025-05-12-at-1.00.28-PM.png 1594w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
Novo Nordisk shares have an unfavorable price trend in the short, medium, and long term, but how does it compare with peers such as Johnson &amp; Johnson, Amgen, and Roche? Sign up for <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-2#:~:text=Turn%20Market%20Chaos,when%20markets%20rebound">Benzinga Edge</a> to find out.
Meanwhile, Novo Nordisk, Pfizer and J&amp;J were trading at least 3% lower in Monday premarket. 
Photo Courtesy: create jobs 51 On Shutterstock.com
Read More: 
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/25/05/45339784/mohamed-el-erian-warns-us-china-deal-reveals-americas-fear-of-empty-shelves-as-markets-rally-on-trade-optimism-peter-schiff-skeptical-without-renminbi-revaluation">Mohamed El-Erian Warns US-China Deal Reveals &#8216;America&#8217;s Fear Of Empty Shelves&#8217; As Markets Rally On Trade Optimism, Peter Schiff Skeptical Without Renminbi Revaluation</a></li>
</ul>

Trump's New Drug Pricing Executive Order Could Rattle Pharma Stocks, With Price Cuts Of Up To 80%: Novo Nordisk, Pfizer And J&J Fall In Premarket

The U.S. Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">American consumers and patients</a>.
This change builds upon the agency&#8217;s Office of Inspection and Investigations&#8217; Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.&nbsp;
&#8220;For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning,&#8221; said FDA Commissioner Martin Makary. &nbsp;
On Tuesday, the FDA <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities?utm_medium=email&amp;utm_source=govdelivery" rel="noreferrer noopener">said</a> it plans to review and improve its foreign inspection program to ensure it meets the highest standards for oversight. Part of this effort includes making it clear that FDA inspectors should not accept travel-related perks like hotel stays or transportation from the companies they inspect.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/05/45225204/iqvia-beats-q1-earnings-expectations-despite-sector-uncertainty-company-navigating-market-conditions-effectively-says-ceo" rel="noreferrer noopener">IQVIA Beats Q1 Earnings Expectations Despite Sector Uncertainty, Company Navigating Market Conditions &#8216;Effectively&#8217; Says CEO</a>
The FDA conducts about 12,000 inspections annually in the U.S. and 3,000 in other countries. While U.S. companies often get surprise inspections, foreign companies usually receive advanced notice, giving them time to prepare and potentially hide problems.
Still, foreign inspections often reveal serious issues, more than twice as often as domestic ones.
In the U.S., inspections are usually unannounced unless specific programs require advance notice to ensure staff and records are available.
Even then, companies can&#8217;t pick the date or time. The FDA says foreign companies shouldn&#8217;t have that option either.
By shifting to more surprise inspections abroad, the FDA aims to better protect American consumers by catching dishonest practices, like falsifying records or hiding violations, before they cause harm.
The agency can take action against any company that tries to delay, block, or refuse an unannounced inspection.
The update follows President&nbsp;Donald Trump&#8217;s signed executive order on Monday to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">imported medicines loom</a>.
The order directs the FDA to reduce the amount of time it takes to approve manufacturing plants in the U.S. by eliminating unnecessary requirements, streamlining reviews, and working with domestic drugmakers to &#8220;provide early support before facilities come online,&#8221; <a target="_blank" href="https://www.whitehouse.gov/fact-sheets/2025/05/fact-sheet-president-donald-j-trump-announces-actions-to-reduce-regulatory-barriers-to-domestic-pharmaceutical-manufacturing/" rel="noreferrer noopener">according</a> to&nbsp;a White House fact sheet.
It also directs the agency to raise inspection fees for foreign manufacturing plants, improve the enforcement of active-ingredient source reporting by overseas producers, and consider publicly listing facilities that don&#8217;t comply.
The White House <a target="_blank" href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/" rel="noreferrer noopener">estimates</a> that it can currently take five to ten years to build new pharmaceutical manufacturing capacity, which it calls &#8220;unacceptable from a national-security standpoint.&#8221;
<a target="_blank" href="https://www.benzinga.com/markets/25/02/43906811/trump-reportedly-warns-big-pharma-move-manufacturing-to-us-or-face-tariffs" rel="noreferrer noopener">Amid tariff uncertainty</a>, many companies have disclosed a wave of investments in recent months to boost production in the U.S.
<ul>
<li>Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) doubled <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. (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 <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 Becton, Dickinson, and Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) also announced its intention to invest $2.5 billion in U.S. manufacturing capacity <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>Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) did not highlight investments in new manufacturing plants; it 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">their products in the U.S</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 sweeping $23 billion investment plan to expand its manufacturing and research infrastructure 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>) announced its 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 (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) announced that it will invest $50 billion in the U.S. over <a href="https://www.benzinga.com/topic/pharmaceuticals" target="_blank" rel="noreferrer noopener">the next five years.</a></li>
<li>Most recently, Bristol-Myers Squibb &amp; Co.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Christopher Boerner, chair and chief executive officer, <a href="https://www.statnews.com/2025/05/05/bristol-myers-squibb-pharmaceutical-policy-us-trump-administration-innovation-tariffs/" target="_blank" rel="noreferrer noopener">shared</a> 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 Stat this week.</li>
</ul>
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Photo by Tada Images via Shutterstock

FDA Expands Surprise Inspections At Foreign Drug And Food Facilities, Targets Double Standards In Overseas Manufacturing Oversight

– Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread of influenza virus, from an infected person to household members by 32% –
– CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus –
– Reducing the spread of infection within households could help limit transmission within institutions and communities, potentially easing the burden of both seasonal and pandemic influenza on healthcare systems –

Genentech's Xofluza Demonstrates 32% Reduction In Household Transmission Of Influenza In Global Phase III Trial

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) announced on Tuesday that it will invest $50 billion in the U.S. over <a href="https://www.benzinga.com/topic/pharmaceuticals">the next five years.</a>
These investments further strengthen Roche's already significant U.S. footprint, which includes 13 manufacturing and 15 R&amp;D sites across the Pharmaceutical and Diagnostics Divisions.
The investment is expected to <a href="https://www.roche.com/media/releases/med-cor-2025-04-22" target="_blank" rel="noreferrer noopener">create</a> over 12,000 new jobs, including nearly 6,500 construction jobs and 1,000 jobs at new and expanded facilities.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44724763/pharma-industry-faces-jitters-as-trump-hints-at-historic-tariffs-bofa-outlines-probable-timeline" rel="noreferrer noopener">Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline</a>
As part of this investment, Roche will increase its footprint of more than 25,000 employees in 24 sites across eight U.S. states. The investment will include: 
<ul>
<li>Expanded and upgraded US manufacturing and distribution capabilities for its innovative medicines and diagnostics portfolio in Kentucky, Indiana, New Jersey, Oregon, and California.</li>
<li>Gene therapy manufacturing facility in Pennsylvania.</li>
<li>A new 900,000-square-foot manufacturing center to support Roche's expanding portfolio of <a href="https://www.benzinga.com/general/biotech/25/04/44791986/whats-going-on-with-viking-therapeutics-structure-therapeutics-stock-on-monday" target="_blank" rel="noreferrer noopener">next-generation weight loss medicines</a>. The company says the location will be announced.</li>
<li>A new manufacturing facility for continuous glucose monitoring in Indiana.</li>
<li>A new R&amp;D center in Massachusetts for conducting artificial intelligence research and as a hub for new cardiovascular, renal, and metabolism R&amp;D efforts.</li>
<li>Significant expansion and upgrading of existing pharmaceuticals and diagnostics R&amp;D centers in Arizona, Indiana, and California.</li>
</ul>
Once all new and expanded manufacturing capacity comes online, Roche will export more medicines from the U.S. than it imports. The company says its diagnostics division already has an export surplus from the U.S. to other countries.
Earlier this month, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) unveiled a sweeping $23 billion investment plan to expand its manufacturing and research infrastructure 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-uncertainties" target="_blank" rel="noreferrer noopener">over the next five years</a>.
The move is part of a broader strategy to ensure that all key Novartis medicines for U.S. patients are produced domestically.
Earlier this year, Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) announced its 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>, while Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) plans to double its U.S. drug manufacturing spending from $23 billion to <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">$50 billion within five years</a>.
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Photo: Gorodenkoff/Shutterstock

Roche Plans $50 Billion US Investment Over 5 Years With 12,000 New Jobs

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) has revealed a $50 billion investment plan centering on manufacturing and research in the U.S., indicating a strategic change as<a href="https://www.benzinga.com/government/regulations/25/04/44847222/trump-administration-opens-probe-into-foreign-drug-imports-eyes-tariffs-under-national-security-law"> potential drug tariffs loom</a>.
What Happened: The Swiss pharmaceutical giant will establish new and expanded facilities across Indiana, Pennsylvania, Massachusetts, and California over the next five years.
The move entails crucial R&amp;D hubs, new production sites for weight-loss and gene therapies, and extended diagnostic operations. The plan is likely to create over 12,000 jobs, including thousands in facility staffing and construction.
See Also: <a href="https://www.benzinga.com/news/global/25/04/44899617/90-chance-of-recession-due-to-trumps-tariffs-sharp-slowdown-is-coming-economist-says">90% Chance Of Recession Due To Trump&#8217;s Tariffs: &#8216;Sharp Slowdown&#8217; Is Coming, Economist Says</a>
Why It Matters: The announcement was made as the pharmaceutical sector readies itself for possible tariffs on imported medicines. While drugs have so far been exempted, President Trump recently <a href="https://www.benzinga.com/25/04/44724763/pharma-industry-faces-jitters-as-trump-hints-at-historic-tariffs-bofa-outlines-probable-timeline">warned </a>that new tariffs on pharmaceuticals are coming shortly.
Roche's CEO Thomas Schinecker said the investment shows the company's "long-standing commitment" to U.S.-based innovation and production, according to the Wall Street Journal.
Once the plan is executed, Roche expects to export more medicines from the U.S. than it imports.
Earlier this month, President Trump proposed a &#8220;<a href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market">major tariff</a>&#8221; on foreign pharmaceuticals, indicating that U.S. dependence on imports poses national security risks. The U.S. Department of Commerce is investigating the effect of these imports on the domestic supply chain, targeting essential medicines and public health readiness.
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</ul>
Photo courtesy: Shutterstock

Roche's $50 Billion US Investment Commitment Includes New Facilities, 12,000 Jobs, Expanded R&D Hubs As Drug Tariffs Loom

Viking Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VKTX#NASDAQ">VKTX</a>),&nbsp;&nbsp;Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) and Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) stocks are trading higher on Monday.
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) announced on Monday that it will discontinue the development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist being investigated for <a href="https://www.benzinga.com/topic/weight-loss" target="_blank" rel="noreferrer noopener">chronic weight management</a>.
A single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury, which resolved after discontinuation of danuglipron.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/42827918/viking-therapeutics-structure-therapeutics-positioned-as-key-pharma-partners-for-weight-loss-products-analyst" rel="noreferrer noopener">Viking Therapeutics, Structure Therapeutics Positioned As Key Pharma Partners For Weight Loss Products: Analyst</a>
Pfizer is one of several drugmakers working to develop an alternative to injectable weight loss drugs. Still, it&#8217;s far behind rivals like Eli Lilly and Novo Nordisk, who already lead the market with weekly injections.
Eli Lilly is developing orforglipron, which could be the first small-molecule weight-loss pill when it launches in 2026. This would give Eli Lilly a two-year lead <a href="https://www.benzinga.com/general/biotech/24/10/41137681/eli-lilly-nears-first-trillion-pharma-title-but-investors-caution-amid-sky-high-valuation" target="_blank" rel="noreferrer noopener">before rivals catch up</a>.
In March, Viking Therapeutics completed subject enrollment in its Phase 2 clinical trial of the oral tablet formulation of VK2735, the company&#8217;s dual agonist of the GLP-1 and glucose-dependent <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/n44490486/viking-therapeutics-announces-completion-of-enrollment-in-phase-2-venture-oral-dosing-trial-of-vk2" rel="noreferrer noopener">insulinotropic polypeptide (GIP) receptors</a>.
VK2375 is being developed in oral and subcutaneous formulations for various metabolic disorders, such as obesity. Viking expects to report data from the study in <a href="https://www.benzinga.com/general/biotech/24/11/41712739/viking-therapeutics-reveals-early-stage-from-experimental-oral-obesity-drug-showing-weight-loss-a" target="_blank" rel="noreferrer noopener">the second half of 2025</a>.
Viking plans to initiate Phase 3 development with the subcutaneous formulation of VK2735 in the first half of 2025.
In June 2024, Structure Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GPCR#NASDAQ">GPCR</a>) unveiled 12-week topline obesity data from its <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/06/39144875/structure-therapeutics-obesity-candidate-is-very-competitive-to-eli-lillys-orforgli" target="_blank" rel="noreferrer noopener">Phase 2a study of GSBR-1290</a>.
In the Phase 2a obesity study, GSBR-1290 demonstrated a clinically meaningful and statistically significant placebo-adjusted mean decrease in weight of&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/06/g39133591/structure-therapeutics-reports-positive-topline-data-from-its-phase-2a-obesity-study-and-capsule-t" rel="noreferrer noopener">6.2% at 12 weeks</a>.&nbsp;
In July 2024, Roche Holdings AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) announced topline results from two arms of an ongoing multi-part Phase 1 clinical trial for CT-996 for&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39812408/roche-highlights-encouraging-data-from-newly-acquired-second-weight-loss-drug-candidate-in-early-" rel="noreferrer noopener">type 2 diabetes and obesity</a>.
The data showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks.
This data is better compared <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39817857/obesity-drugs-focused-stocks-tumble-on-wednesday-whats-going-on-with-eli-lilly-novo-nordisk-vikin" rel="noreferrer noopener">to existing competitors</a>.
In June 2023, Pfizer discontinued the clinical development of another GLP-1-RA candidate, lotiglipron (PF-07081532), due to pharmacokinetic data from Phase 1 studies and laboratory measurements of elevated&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/11/35757948/what-are-pfizers-prospects-in-obesity-pill-market-analysts-say-optimism-cautiousness-surround-wit" rel="noreferrer noopener">transaminases (liver enzymes)</a>.
In March, Altimmune Inc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALT#NASDAQ">ALT</a>) unveiled the first disclosure of Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD) as potential developments&nbsp;for its <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44330443/altimmune-expands-weight-loss-drug-pemvidutides-potential-to-alcohol-related-disorders" rel="noreferrer noopener">obesity drug, pemvidutide</a>.
Phase 2 trials for pemvidutide in AUD and ALD are expected to start in the second and third quarters of 2025, respectively.
Price Action: LLY stock is up 1.14% at $739.26, NVO stock is up 1.68% at $65.82, ALT stock is up 3.40% at $4.56, VKTX stock is up 13.5% at $25.21
GPCR stock is up 8.36% at $17.23 at the last check on Monday.
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GPCR

VKTX

What's Going On With Viking Therapeutics, Structure Therapeutics Stock On Monday?

Omeros Corporation&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) on Thursday established the Omeros Oncology Clinical Steering Committee to advance Omeros&#8217; OncotoX biologics program focused on <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">acute myeloid leukemia (AML)</a>.
AML is the most fatal form of leukemia. It accounts for approximately 80% of acute leukemias in adults and one-third of all cancers <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b44733942/omeros-announces-the-omeros-oncology-clinical-steering-committee-for-aml-to-help-guide-omeros-prop" rel="noreferrer noopener">affecting the blood/bone marrow</a>.
Omeros&#8217; OncotoX program for AML consists of proprietary targeted, engineered molecules (about half the size of an antibody) that deliver a toxic payload within the cancer cells, thereby killing them.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/12/42598739/omeros-antibody-improves-overall-survival-in-rare-complication-after-stem-cell-transplant-stock-surges" rel="noreferrer noopener">Omeros Antibody Improves Overall Survival In Rare Complication After Stem Cell Transplant, Stock Surges</a>
The steering committee will assist Omeros with developing the OncotoX-AML program, designing clinical trials, and interacting with institutional review boards, and it will also participate in OncotoX-AML clinical trials.
In vivo&nbsp;and&nbsp;ex vivo&nbsp;studies have shown that the OncotoX-AML therapeutic is highly effective even at very low doses, providing a significant survival benefit over currently approved combination therapy, like AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Genentech&#8217;s Venclexta (venetoclax) and Bristol Myers Squibb &amp; Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Vidaza azacitidine).
In studies using primary AML derived from patients, the OncotoX molecule preferentially and efficiently kills AML blasts (abnormal myeloid cells).
OncotoX-AML also targets leukemia stem cells (LSC), often refractory to chemotherapy.
The OncotoX-AML therapeutic is designed specifically to kill both AML blasts and LSCs that can lead to relapse.
Preliminary&nbsp;in vivo&nbsp;tolerability studies demonstrate that the OncotoX therapeutic is well tolerated at doses substantially greater than one order of magnitude above efficacious doses without causing neutropenia or meaningful changes in blood chemistry values.
Omeros is initiating IND-enabling work for its OncotoX-AML therapeutic.
D. Boral analyst Jason Kolbert writes, &#8220;This development is particularly important given the persistent challenges in AML treatment. Despite recent drug approvals, therapeutic options for AML remain limited, especially for patients who are elderly, relapse-prone, or harbor high-risk mutations.&#8221;
Kolbert adds that chemotherapy and existing antibody-drug conjugates often fail to provide durable responses due to narrow therapeutic indices and toxic side effects. By demonstrating high efficacy in preclinical models without significant toxicity, OncotoX-AML presents the potential to address long-standing gaps in AML care.
The analyst maintains a Buy rating on Omeros with <a target="_blank" href="https://www.benzinga.com/quote/OMER/analyst-ratings" rel="noreferrer noopener">a price target of $36</a> while modeling Omeros&#8217; lead therapy, narsoplimab.
In February, the company resubmitted biologics license application for narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Omeros expects the target date for FDA action under the Prescription Drug User Fee Act to be six months following the date of resubmission to the FDA, meaning, in this case, the PDUFA date would be<a href="https://www.benzinga.com/pressreleases/25/03/b44570592/omeros-corporation-reports-fourth-quarter-and-year-end-2024-financial-results" target="_blank" rel="noreferrer noopener"> September 2025</a>.
The company expects to submit our European marketing authorization application for narsoplimab in TA-TMA in the first half of 2025.&nbsp;
Price Action: OMER stock is up 13.2% at $6.64 at last check Friday.
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Photo: Gorodenkoff/Shutterstock

OMER

Omeros' New Leukemia Drug Team Ignites Hope For Cancer Fight

Press Releases

New England Journal of Medicine Publishes Phase III Data Showing Single-dose Xofluza Significantly Reduces Influenza Virus Transmission

Roche and Genentech Announce New North Carolina Manufacturing Facility

Small Cap

Roche announces $550 million investment to expand its Indianapolis diagnostics manufacturing hub

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Genentech Provides Update on FDA Advisory Committee Meeting on Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

FDA Approves Genentech's Susvimo for Diabetic Retinopathy

New Two-year Follow-up of Genentech's Columvi Extends Overall Survival in Relapsed or Refractory Diffuse Large B-cell Lymphoma Patients

Genentech's Fenebrutinib Maintains Near-Complete Suppression of Disease Activity and Disability Progression for up to Two Years in People With Relapsing Multiple Sclerosis

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