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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.

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El cannabis medicinal podría reducir las recetas de ansiolíticos. Conoce su impacto en pacientes, farmacéuticas y la salud pública.

El cannabis medicinal reduce el uso de ansiolíticos: ¿Qué impacto tendrá en las grandes farmacéuticas?

ROCHE HOLDING LTD S/ADR by Roche Holding Ltd

Roche Holding AG

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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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 –

RHHBF

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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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.
Read Next:
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<li><a href="https://www.benzinga.com/25/04/44907170/upcoming-pfizer-earnings-call-might-be-focused-on-tariffs-policy-risks-and-obesity-pipeline">Upcoming Pfizer Earnings Call Might Be Focused On Tariffs, Policy Risks And Obesity Pipeline</a></li>
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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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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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Analyst Ratings

ABBV

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Omeros' New Leukemia Drug Team Ignites Hope For Cancer Fight

Tempest Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TPST#NASDAQ">TPST</a>) said on Thursday it had retained MTS Health Partners as a financial advisor. The company plans to explore strategic alternatives to advance its clinical-stage programs and maximize stockholder value.
Strategic alternatives may include M&amp;A, partnerships, joint ventures, licensing arrangements or <a href="https://www.benzinga.com/pressreleases/25/04/g44723521/tempest-announces-plan-to-explore-strategic-alternatives-to-advance-promising-pipeline-of-clinical" target="_blank" rel="noreferrer noopener">other strategic transactions</a>.
&#8220;Notwithstanding the positive randomized data set from the amezalpat Phase 2 and its blockbuster potential in first-line HCC, as well as the potential of TPST-1495 as it moves towards a Phase 2 in FAP, the capital markets have been unavailable to support the next stage of advancement,&#8221; said Stephen Brady, president and chief executive officer of Tempest.&nbsp;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40401811/why-is-small-cap-tempest-therapeutics-stock-trading-higher-on-thursday" rel="noreferrer noopener">Why Is Small-Cap Tempest Therapeutics Stock Trading Higher On Thursday?</a>
On Thursday, Scotiabank downgraded Tempest Therapeutics from Sector Outperform to Sector Perform while raising the price target from $7 to $9.
In October 2024, the company entered into an agreement with&nbsp;Roche Holdings AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a Phase 3 trial for the first-line&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41271516/why-is-cancer-focused-tempest-therapeutics-stock-trading-higher-on-thursday" rel="noreferrer noopener">treatment of liver cancer</a>.
Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study.
Analyst George Farmer writes that Roche appears to have no financial interest in the Phase 3 evaluation of amezalpat in combination with atezo/bev, despite the quality of results that Tempest Therapeutics <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39412888/whats-going-on-with-cancer-focused-tempest-therapeutics-stock-on-thursday" rel="noreferrer noopener">presented last June</a>.
Other potential partners with deep pockets, like AstraZeneca and Bristol Myers Squibb &amp; Co, with their own cancer immunotherapies, are uninterested.
&#8220;Lack of partner interest in this program, including negligible BD engagement from Roche beyond promise of providing a free Phase 3 supply of atezolizumab, indicates to us that this is probably a broken story that cannot be repaired without additional early-stage clinical exploration,&#8221; Farmer writes.
&#8220;We think the company may ultimately attract a buyer, but we would not expect a significant transaction premium above the current trading range,&#8221; Farmer adds.
HC Wainwright downgraded Tempest Therapeutics from Buy to Neutral while maintaining the price target of $16.
TPST Price Action: Tempest Therapeutics stock is down 6.93% at $6.65 at publication on Thursday.
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Tempest Therapeutics, Inc. - Common Stock

TPST

Tempest Weighs M&A, Analyst Sees A "Broken Story" Despite Phase 2 Liver Cancer Study Success

U.S.&nbsp;President Donald Trump, on Tuesday, disclosed plans for a "major tariff" on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
"We're&nbsp;going to be announcing very&nbsp;shortly a major tariff on&nbsp;pharmaceuticals… when they hear that&nbsp;they will leave China, they&nbsp;will leave other places because… most of their product&nbsp;is sold here," Trump expressed at&nbsp;a National Republican <a target="_blank" href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" rel="noreferrer noopener">Congressional Committee&nbsp;dinner</a>.
He also told reporters on board his Air Force One plane that "pharma" tariffs would arrive "at a level that you haven't really seen before," saying these would be announced "in the near future," BBC <a target="_blank" href="https://www.bbc.com/news/articles/cedyylj1v32o" rel="noreferrer noopener">report</a> added.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">Trump Tariff Strategy Creates ‘Self-Inflicted Market Debacle': Analyst</a>
When President Trump announced tariffs last week, he excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" rel="noreferrer noopener">on pharmaceutical imports</a>.&nbsp;
On Wednesday, in a surprise announcement from President Donald Trump, a 90-day pause on tariffs for countries that have not retaliated <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">against U.S. trade measures.</a>
The news ignited a broad risk-on rally, catapulting major indices to multi-month highs and sending volatility plunging.
Trump's latest Truth Social post slammed China for showing "a lack of respect" and declared an immediate 125% tariff hike on Chinese goods.
"At some point, hopefully in the near future, China will realize that the days of ripping off the U.S.A. and other Countries is no longer sustainable or acceptable," he said.
He praised the over 75 countries that, in his words, "have not, at my strong suggestion, retaliated in any way, shape, or form."
As a reward, those countries would benefit from a temporary 10% reciprocal tariff and a 90-day pause on additional duties.
The biopharma industry has historically been shielded from tariffs, including during Trump's first term.
Although Trump didn't provide many details, his remarks have unsettled buyers, especially those who depend on medicines from India. India provides nearly half of all generic drugs used in the U.S., helping cut billions from healthcare costs.
The U.S. is a major market, buying about a third of India's $13 billion in yearly drug exports.
Indian drug companies warn that if tariffs are added, they'd have to raise prices—which could increase healthcare costs in the U.S.
Even though some companies like Cipla and Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) have factories in the U.S., most say it's too expensive to move production for low-profit generic drugs.
BofA Securities analyst says if the Trump administration plans to impose tariffs on the pharmaceutical industry, it would likely do so through a "Section 232 investigation" under the Trade Expansion Act of 1962 to determine whether importing certain goods threatens national security.
The typical timeline for a Section 232 investigation is about a year. If the same timeline applied here, tariffs on drug imports likely wouldn't take effect until late in the year—at the earliest.
It's unclear whether the Section 232 investigation into the drug industry is about to start, but based on recent comments from the administration, it seems possible. However, launching an investigation doesn't guarantee that tariffs will follow.
As the first quarter 2025 earnings season starts soon, analyst Tim Anderson says it will be worth watching whether companies discuss potential tariffs during earnings calls.
That said, any actual earnings impact likely wouldn't show up until sometime after 2025, which could leave investors with more questions than answers.
Wedbush analyst Daniel Ives <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">on Tuesday wrote</a> that "saying we can just make this in the USA" understates how complex the supply chain in Asia really is—and how electronics, chips, semiconductors, hardware, and smartphones have been built for U.S. consumers over the past 30 years."
Shares of major drugmakers such as Gilead Sciences&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Eli Lilly&nbsp;And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Roche&nbsp;Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi&nbsp;SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Novartis&nbsp;AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Argenx&nbsp;SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB&nbsp;SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>), Novo Nordisk&nbsp;A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell on Wednesday, only reverse course later after the 90-day tariff pause.
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Photo by MargJohnsonVA via Shutterstock

ARGX

GILD

UCBJF

UCBJY

Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) on Thursday presented new data at the AD/PD 2025 International Conference on Alzheimer&#8217;s <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">and Parkinson&#8217;s Diseases</a>.
Highlights included presentations from the ongoing trontinemab Phase 1b/2a Brainshuttle AD study, which <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-04-03" rel="noreferrer noopener">demonstrated</a> dose-dependent rapid amyloid depletion from the brain and the potential of the Elecsys pTau181 plasma test to rule out amyloid pathology.
Also Read: <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">Sarepta/Roche Suspend Elevidys Gene Therapy Trials In Europe After Patient Death</a>
<ul>
<li>Preliminary results for trontinemab from 114 participants in the 1.8 or 3.6 mg/kg suggest a rapid and deep, dose-dependent reduction of amyloid plaques in the brain as measured by amyloid positron emission tomography (PET).</li>
<li>Amyloid plaques are extracellular deposits of aggregated amyloid beta peptides (Aβ) that are a hallmark of Alzheimer&#8217;s disease, disrupting brain function and contributing to cognitive decline.</li>
<li>Trontinemab reduced amyloid levels below the 24 centiloid threshold in 81% of participants (n=21/26) in the 3.6 mg/kg dose group after 28 weeks.</li>
<li>These data were reinforced by early and significant reductions in fluid biomarkers of Alzheimer&#8217;s disease, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin measured in cerebrospinal fluid and plasma.</li>
</ul>
Trontinemab continues to show a favorable safety and tolerability profile. Amyloid-related imaging abnormalities-edema/effusion (ARIA-E) were observed in &lt;5% (n=3/114) of participants (blinded data), which were radiographically mild, and there was one case associated with mild symptoms.
Trontinemab is currently being studied in the Phase Ib/IIa Brainshuttle AD study assessing the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of trontinemab in participants with Alzheimer&#8217;s disease.
Roche also announced that it would initiate a Phase 3 program for trontinemab, which is expected later this year.
Results from 604 participants in a multicentre study of Roche&#8217;s Elecsys pTau181 plasma test were presented, demonstrating its potential to accurately rule out amyloid pathology, a hallmark of Alzheimer&#8217;s disease, in people with cognitive impairment.
Roche anticipates tests being available in Europe by late 2025, with the U.S. following.
Price Action: RHHBY stock closed lower by 4.37% to $37.65 on Friday.
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Roche To Start Phase 3 Study For Alzheimer's Prospect This Year After New Data From Phase 2

President Donald Trump announced tougher-than-anticipated tariffs on Wednesday, but there are some <a href="https://www.benzinga.com/topic/tariffs" target="_blank" rel="noreferrer noopener">notable exemptions</a>.
Trump excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff <a href="https://www.benzinga.com/news/global/25/04/44631606/trumps-tariff-exemptions-include-semiconductors-pharmaceuticals-oil-and-more" target="_blank" rel="noreferrer noopener">on pharmaceutical imports</a>. 
&#8220;The United States can no longer produce enough antibiotics to treat our sick,&#8221; Trump said Wednesday. &#8220;We have a tremendous problem, we have to go to foreign countries to treat our sick. If anything ever happened from a war standpoint, we wouldn&#8217;t be able to do it.&#8221;
The biopharma industry has historically been shielded from tariffs, including during Trump's first term. Investors had feared global tariffs could disrupt the sector, given its significant manufacturing presence in Europe. The Morningstar <a target="_blank" href="https://www.morningstar.com/stocks/biopharma-industry-exempt-global-10-tariff-we-still-see-margin-tax-rate-risks" rel="noreferrer noopener">report</a> says that with the U.S. importing approximately $200 billion in pharmaceuticals in 2024, a 10% tariff could have resulted in a $20 billion cost to the industry, with some of the largest firms facing annual tariffs of up to $1 billion.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/25/04/44592073/tariffs-could-shake-building-industry-homebuilders-plumbing-flooring-face-rising-costs" rel="noreferrer noopener">Tariffs Could Shake Building Industry: Homebuilders, Plumbing, Flooring Face Rising Costs</a>
Per the Morningstar report on Thursday, a future global tariff on pharmaceuticals remains a risk despite the exemption, potentially pressuring gross margins and long-term tax rates. Companies may need to adjust their manufacturing strategies, though large-cap biopharma firms are expected to maintain strong economic positions. Tariffs could drive near-term margin pressures and lead to long-term U.S. manufacturing investments.
However, new facilities would take years to gain approval, especially with ongoing FDA staff <a href="https://www.benzinga.com/25/04/44634464/despite-headwinds-biotech-sell-off-could-offer-buying-opportunity-bofa" target="_blank" rel="noreferrer noopener">reductions affecting inspections</a>. If U.S. manufacturing increases, corporate tax rates could rise closer to the current 21% rate &#8211; a level Trump aims to maintain through the Republican-controlled Congress.
However, the medical device industry has not been spared, with diabetes device makers appearing to be the hardest hit.
Diabetes device manufacturers, including Dexcom Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DXCM#NASDAQ">DXCM</a>), Insulet Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PODD#NYSE">PODD</a>) and Tandem Diabetes Care, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNDM#NASDAQ">TNDM</a>) are among the most affected.
Larger cardiac and orthopedic device makers, such as Boston Scientific Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BSX#NYSE">BSX</a>), Edwards Lifesciences Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EW#NYSE">EW</a>) and Zimmer Biomet Holdings, Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ZBH#NYSE">ZBH</a>) have seen minimal share movement and are expected to shift manufacturing to mitigate tariff effects.
The report <a href="https://www.morningstar.com/stocks/medical-device-industry-swept-up-tariffs-diabetes-device-makers-bear-brunt" target="_blank" rel="noreferrer noopener">notes</a> that among diabetes device makers, Tandem Diabetes appears particularly vulnerable due to its reliance on foreign components and manufacturing, limiting its ability to shift production.
The sector could face further challenges if European competitors, such as Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) and Ypsomed, gain an advantage or if Europe imposes reciprocal tariffs, intensifying competitive pressures.
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TNDM

Trump Tariffs Spare Drugmakers But Threaten Diabetes Device Industry

In March,&nbsp;Sarepta Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy.
The company reported a patient death following treatment with Elevidys, having suffered <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>.
Acute liver injury is a known possible side effect of Elevidys and other AAV-mediated gene therapies and is highlighted in the prescribing information.
On Wednesday, Sarepta and Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) temporarily <a target="_blank" href="https://www.duchenneuk.org/roche-temporarily-halts-clinic-studies/" rel="noreferrer noopener">halted</a> several clinical studies.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/43232532/sarepta-therapeutics-duchenne-gene-therapy-shows-sustained-benefits-and-disease-stabilization-at-two-years" rel="noreferrer noopener">Sarepta Therapeutics&#8217; Duchenne Gene Therapy Shows Sustained Benefits And Disease Stabilization At Two Years</a>
Roche, the company to which the treatment is licensed outside the US, has said that this was at the European Medicines Agency&#8217;s (EMA) request.
The companies have a therapeutic clinical hold on Study 104, Study 302, and Study 303 in the EU until the analysis of the cause of death is complete.
Roche is also pausing the enrollment and dosing of participants in the U.K. for its ENVOL study.
Patient safety monitoring for already enrolled participants and ongoing collection of data will continue.
In June 2024, the EMA validated and <a target="_blank" href="https://www.roche.com/investors/updates/inv-update-2024-06-24" rel="noreferrer noopener">initiated</a> a review of the marketing authorization application for Elevidys, a gene therapy for ambulatory patients aged 3-7 years old with Duchenne muscular dystrophy.
HC Wainwright upgraded Sarepta on Wednesday from Sell to Neutral, saying it is trading within a fair range.
Analyst Mitchell S. Kapoor still anticipates Elevidys revenue will fall short in the second half of 2025—especially after the recent patient death due to acute liver injury.
Kapoor sees a risk that Elevidys sales may decline faster than expected, possibly as early as Q2 2025, due to growing hesitation from doctors and patients regarding its safety. The treatment&#8217;s limited effectiveness heightens this concern.
The analyst maintains the price <a target="_blank" href="https://www.benzinga.com/quote/SRPT/analyst-ratings" rel="noreferrer noopener">forecast of $75 per share</a>.
Needham maintained Sarepta Therapeutics with a Buy, lowering the price forecast from $202 to $183.
Price Action: SRPT stock is down 6.68% at $58.30 at the last check Thursday.
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Image via Sarepta Therapeutics

SRPT

Sarepta/Roche Suspend Elevidys Gene Therapy Trials In Europe After Patient Death

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) on Wednesday announced data from MUSETTE Phase 3 trial of a high dose of Ocrevus (ocrelizumab) intravenous (IV) infusion in adult patients with relapsing multiple sclerosis (RMS) compared with the currently approved Ocrevus IV 600 mg dose.
Patients received treatment with Ocrevus high dose or IV 600 mg every 24 weeks for a minimum of 120 weeks.
The <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-04-02" rel="noreferrer noopener">trial</a> did not meet its primary endpoint in showing additional benefit in slowing disability progression, as measured by a composite disability over a period of at least 120 weeks of treatment.
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The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of Ocrevus IV 600 mg.
In addition, in several predefined analyses on disease activity, Ocrevus IV 600 mg showed clinically meaningful results with the lowest annualized relapse rate (ARR) observed during the double-blind period of a Phase III study in RMS.
The MUSETTE data further support the efficacy and safety profile of the currently approved OCREVUS IV 600 mg dose for RMS.
Ocrevus IV and Ocrevus subcutaneous (SC; marketed as OCREVUS ZUNOVO [ocrelizumab hyaluronidase-ocsq] in the U.S.) are approved for both RMS (including relapsing-remitting multiple sclerosis and active, or relapsing secondary progressive multiple sclerosis, as well as clinically isolated syndrome in the U.S.) and primary progressive multiple sclerosis.
Both Ocrevus IV and subcutaneous are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart, with subsequent doses given as single 600 mg infusions.
Ocrevus subcutaneous is given as a single 920 mg subcutaneous injection every six months.
Price Action: RHHBY stock is down 3.89% at $39.48 at the last check Wednesday.
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Photo by OleksSH via Shutterstock

Why Is Pharma Giant Roche Stock Trading Lower On Wednesday?

The Association of the British Pharmaceutical Industry (ABPI) is urging ministers to address excessive levies on manufacturers to ensure the sector remains competitive globally.
The life sciences industry, a key pillar of the UK&#8217;s economic strategy, could struggle to attract investment unless payment rates are adjusted.
Last week, the government <a href="https://www.abpi.org.uk/media/news/2025/march/uk-set-to-demand-a-third-of-pharmaceutical-company-revenue-in-second-half-of-2025/" target="_blank" rel="noreferrer noopener">proposed</a> raising the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies&#8217; National Health Service (NHS) sales in the second half of 2025.
The payment rate is the revenue companies must hand back to the government on their sales of branded medicines to the NHS. It is an additional charge to the taxes paid by companies.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44362710/uk-pharma-industry-trade-association-restores-wegovyozempic-maker-novo-nordisks-membership-after-two-years-of-suspension" rel="noreferrer noopener">UK Pharma Industry Trade Association Restores Wegovy/Ozempic Maker Novo Nordisk&#8217;s Membership After 2 Years Of Suspension</a>
UK pharmaceutical leaders from Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), Boehringer Ingelheim, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>), Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) and UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) point to the challenges to investing in the U.K.
The pharmaceutical sector <a target="_blank" href="https://www.abpi.org.uk/media/news/2025/march/medicine-levy-makes-the-uk-un-investable-say-pharma-leaders/" rel="noreferrer noopener">contributes</a> over 17.6 billion pounds ($22.76 billion) directly to the U.K. economy, with an additional 45 billion generated through research and development spillovers.
However, companies argue that growth is being stifled due to escalating mandatory payments. Under the current system, firms must pay between 23.5% and 35.6% of their branded medicine sales revenue to the NHS. This is significantly higher than other European nations, where comparable rates range from 5.7% to 9%, ABPI writes.
The ABPI report highlights that while the UK once led in medicine availability, it has slipped to ninth place in Europe over the past decade. One year after launch, medicine usage in England is only 52% of the average of comparable nations, rising to 62% after five years.
Additionally, the UK has dropped from fourth to tenth in global rankings for phase 3 clinical trials, lagging behind Spain, Germany and Italy.
Investment in UK pharmaceutical research has also declined, with the country&#8217;s share of global R&amp;D investment falling from 7.3% to 5.7% in just three years.
This marks the fastest decline of any European G7 nation. Meanwhile, NHS funding has grown by 33% in real terms over the past decade, but spending on branded medicines has been capped at annual growth rates between 1.1% and 2%, declining by 11% when adjusted for inflation.
The industry and government have long collaborated on agreements to ensure NHS access to medicines.
The latest, the Voluntary Scheme for Branded Medicines, Pricing, Access, and Growth (VPAG), was intended to realign UK payment rates with international standards. While rates for newer medicines briefly dropped to 15.1% in 2024, they surged again in 2025 to 23.5% for newer medicines, with companies still paying 10.6%-35.6% for older products.
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</ul>
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Eurozone

AMGN

BIIB

DSNKY

Pharmaceutical Firms Say UK Investment Is 'Unlikely' Unless Payment Levy Is Adressed

On Wednesday, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) announced safety and efficacy results from the Phase 3 program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of patients aged two to &lt;18 years with <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">spinal muscular atrophy (SMA)</a>.
In the Phase 3 STEER study, <a target="_blank" href="https://www.novartis.com/news/media-releases/new-novartis-phase-iii-data-demonstrate-meaningful-efficacy-and-safety-results-intrathecal-onasemnogene-abeparvovec-broad-patient-population-sma" rel="noreferrer noopener">treatment</a> with OAV101 IT led to a statistically significant 2.39-point improvement on the Hammersmith Functional Motor Scale Expanded (HFMSE), an assessment of motor ability and disease progression, vs. 0.51 points in the sham control arm.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43629559/novartis-to-beef-up-heart-disease-offering-with-3-billion-blackstone-backed-anthos-therapeutics-deal" rel="noreferrer noopener">Novartis To Beef Up Heart Disease Offering With $3 Billion Blackstone-Backed Anthos Therapeutics Deal</a>
Novartis <a target="_blank" href="https://www.novartis.com/news/media-releases/novartis-intrathecal-onasemnogene-abeparvovec-phase-iii-study-meets-primary-endpoint-children-and-young-adults-sma" rel="noreferrer noopener">released</a> topline data from the Phase 3 STEER study in December 2024.
In the Phase 3b STRENGTH study, treatment with OAV101 IT in patients who have discontinued treatment with Biogen Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) Spinraza (nusinersen) or Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Evrysdi (risdiplam) demonstrated stabilization of motor function over 52 weeks of follow-up.
The results add to the growing body of evidence within the OAV101 IT development program, which has evaluated a broad population of over 170 patients with SMA, spanning a total of over 6.4 years across the STEER, STRENGTH, and Phase 1/2 STRONG studies.
OAV101 IT is an investigational gene replacement therapy designed to directly address the genetic root cause of the disease by replacing the nonworking&nbsp;SMN1 gene with a single dose.
In the registrational STEER study, efficacy and safety were studied in treatment naïve patients with SMA Type 2, aged two to less than 18 years, who could sit but had never walked independently. Key findings:
<ul>
<li>The trial met its primary endpoint of change from baseline to 52 weeks in HFMSE score, with OAV101 IT demonstrating a statistically significant 2.39-point improvement on the HFMSE vs 0.51 points in the sham group.</li>
<li>All secondary endpoints consistently favor OAV101 IT, despite not achieving statistical significance due to the pre-planned multiple testing procedure.</li>
</ul>
The open-label Phase 3b STRENGTH study evaluated the safety, tolerability and efficacy of OAV101 IT in patients with SMA aged two to less than 18 years who had discontinued treatment with nusinersen or risdiplam.&nbsp;Key findings:
<ul>
<li>OAV101 IT demonstrated a favorable safety profile that was consistent with the STEER study.</li>
<li>The motor endpoint of efficacy, HFMSE, demonstrated stabilization for the overall study population over 52 weeks. The increase from baseline to 52 weeks in HFMSE least squares (LS) total score was 1.05.</li>
</ul>
Price Action: NVS stock is down 0.75% at $111.38 at the last check Wednesday.
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Photo by Taljat David via Shutterstock

Novartis New Data From Single-Dose Gene Therapy Shows Meaningful Efficacy, Safety In Patients With Spinal Muscular Atrophy

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) confirmed a licensing agreement with Zealand Pharma on Wednesday that will see the two companies <a href="https://www.benzinga.com/topic/weight-loss">co-develop petrelintide</a>.
Petrelintide is Zealand Pharma's amylin analog. It&#8217;s currently in phase 2 clinical development.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41097630/roche-fast-tracks-obesity-drug-development-eyes-over-3b-sales-potential" rel="noreferrer noopener">Roche Fast-Tracks Obesity Drug Development, Eyes Over $3B Sales Potential</a>
Combining petrelintide with Roche's dual GLP-1/GIP receptor agonist CT-388 will further strengthen Roche's pipeline in cardiovascular, renal, and metabolic (CVRM) diseases.
As a part of the <a target="_blank" href="https://www.roche.com/investors/updates/inv-update-2025-03-12" rel="noreferrer noopener">agreement</a>, Zealand Pharma and Roche will co-commercialize petrelintide in the U.S. and Europe.
Roche will obtain exclusive rights to commercialization in the rest of the world and be responsible for commercial manufacturing and supply.
Zealand Pharma will receive upfront cash payments of $1.65 billion. This includes $1.4 billion due upon closing, and $250 million over the first two anniversaries of the collaboration.
Zealand Pharma is also eligible for development milestones of $1.2 billion primarily linked to initiation of Phase 3 trials with petrelintide monotherapy and sales-based milestones of $2.4 billion, for a total consideration of up to $5.3 billion to Zealand Pharma.
Profits and losses for petrelintide and petrelintide/CT-388 will be shared on a 50/50 basis in the U.S. and Europe, and Zealand Pharma is eligible to receive tiered double-digit royalties up to high teens % royalties on net sales in the rest of the world.
Zealand Pharma will pay Roche $350 million, offsettable against milestone payments, for the petrelintide/CT-388 fixed-dose combination product or next-generation petrelintide combination products being pursued under the collaboration agreement.
The transaction is expected to close in the second quarter. 
In December 2023, Roche acquired a privately held obesity company, Carmot Therapeutics, for $2.7 billion in cash. Additionally, Carmot's equity holders are entitled to receive payments of up to $400 million depending on <a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36064233/roche-joins-bandwagon-to-challenge-novo-nordisk-eli-lilly-for-weight-loss-drugs" rel="noreferrer noopener">achieving certain milestones</a>.&nbsp;
Price Action: RHHBY stock is up 5.55% at $44.33 during the premarket session at the last check Wednesday.
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Contracts

Roche Further Boosts Obesity Pipeline With Zealand Pharma Deal Worth $5.3 Billion For Weight Loss Drugs

Zealand Pharma and Roche enter collaboration and license agreement to co-develop and co-commercialize petrelintide as a future foundational therapy for people with overweight and obesity
<ul>
<li>The companies will co-develop and co-commercialize petrelintide monotherapy and potential combination products, including petrelintide/CT-388, in the U.S. and Europe</li>
<li>Zealand Pharma will receive upfront cash payments of USD 1.65 billion, including USD 1.4 billion due at closing and USD 250 million in anniversary payments over two years, as well as potential milestone payments, for a total consideration of up to USD 5.3 billion</li>
<li>Profits and losses will be shared on a 50/50 basis for petrelintide and petrelintide/CT-388 in the U.S. and Europe, and Zealand Pharma is eligible to royalties on net sales in the rest of the world</li>
<li>Zealand Pharma will pay Roche USD 350 million for the contribution of CT-388 in the first combination product arising from the collaboration</li>
<li>Collaboration and license agreement aims to unlock the full value of petrelintide, redefining the standard of care for people with overweight and obesity by establishing the leading amylin-based franchise</li>
<li>Zealand Pharma will host a conference call today March 12 at 1pm CET / 8am ET to discuss the agreement</li>
</ul>

RHHVF

Zealand Pharma Secures $1.65B Upfront In Strategic Collaboration With Roche To Advance Petrelintide For Obesity And Metabolic Disorders

Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Gazyva&#xAE; (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva plus standard therapy compared with standard therapy alone.The FDA is expected to make a decision on approval by October 2025.

Genentech's Gazyva Moves Closer to FDA Approval for Lupus Nephritis After Positive Phase III Trial

– TNKase&#xAE; (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years –
– Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care –
– Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, TNKase and Activase&#xAE; (alteplase)–
Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>), today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase&#xAE; (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase marks Genentech's second approval for stroke, reinforcing the company's long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase and Activase&#xAE; (alteplase).
TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.

FDA Approves Genentech's TNKase In Acute Ischemic Stroke In Adults

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) released data Sunday on its Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase 3 OUtMATCH study for Xolair (omalizumab) for one or more food allergies.
Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches.
<ul>
<li>In the first head-to-head trial comparing Xolair to OIT, the <a href="https://www.roche.com/media/releases/med-cor-2025-03-02" target="_blank" rel="noreferrer noopener">study</a> met its primary endpoint, showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein and two other food allergens without experiencing an allergic reaction, compared to 19% in the OIT group.</li>
<li>These findings were largely driven by the high rates of adverse events (AEs) in the OIT group.</li>
<li>Serious AEs (30.5% for OIT vs. 0% for Xolair), AEs leading to treatment discontinuation (22% vs. 0%), and AEs treated with epinephrine (37.3% vs. 6.9%) were all more common in the OIT group.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42597251/roche-prothena-partnered-mid-stage-parkinsons-trial-misses-primary-endpoint-but-cling-on-signs-of-clinical-benefits" rel="noreferrer noopener">Roche-Prothena Partnered Mid-Stage Parkinson&#8217;s Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits</a>
Additionally, preliminary results from Stage 3 of the OUtMATCH study provide early data on introducing allergenic foods into a patient&#8217;s diet after stopping Xolair.
Stage 3 is ongoing, and study investigators continue to analyze data from additional patients who completed Stage 2 and then entered Stage 3.
In the US, Genentech, a member of the Roche Group, and Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) are co-developing and co-promoting Xolair.
Last February, the FDA approved Xolair for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older <a target="_blank" href="https://www.benzinga.com/pressreleases/24/02/b37182116/fda-approves-xolair-as-first-and-only-medicine-for-children-and-adults-with-one-or-more-food-aller" rel="noreferrer noopener">with IgE-mediated food allergy</a>.
Price Action: RHHBY stock closed at $41.74 on Friday.
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Image: Shutterstock

Roche Touts Food Allergy Drug As Superior Than Oral Immunotherapy

– First-ever head-to-head trial comparing Xolair and oral immunotherapy (OIT) –
– Results were featured as late-breakers at the 2025 AAAAI Annual Meeting –
– Xolair is the only U.S. FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies –

Reported Sunday, Roche's Genentech Phase III Study Finds Xolair More Effective And Safer Than Oral Immunotherapy For Food Allergies

Press Releases

New England Journal of Medicine Publishes New Data for Genentech's Gazyva Which Shows Superiority Over Standard Therapy in People With Active Lupus Nephritis

FDA Approves Genentech's Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)

Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies

FDA Approves Genentech's TNKase® in Acute Ischemic Stroke in Adults

FDA Accepts Supplemental Biologics License Application for Genentech's Gazyva for the Treatment of Lupus Nephritis

Small Cap

Quest Diagnostics Introduces HPV Specimen Self-Collection for Cervical Cancer Screening

Genentech Provides Update on Phase III Ocrevus High Dose Study in People With Relapsing Multiple Sclerosis

Genentech and Roche Present Novel Therapeutic and Diagnostic Advancements in Alzheimer's at AD/PD 2025

Oak Hill Bio Enters into Exclusive License Agreement with Roche to Obtain Global Rights for a Phase 3-Ready, Potential Best-in-Class Treatment for Individuals with Angelman Syndrome

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