- Roche launches the cobas eplex respiratory pathogen panel 3, a fast and comprehensive test to help clinicians treat patients with respiratory infections, in CE markets
Mar 24, 2026
The new test detects up to 250 viruses and bacteria, including SARS-CoV-2, influenza, Bordetella pertussis, and RSV, in a single patient sample. Rapid results enable doctors to make fast, confident and critical treatment decisions that are vital for high-risk patients. Designed for the cobas eplex system, the test is easy to use and available around the clock, helping hospitals manage surges in respiratory cases.
PLEASANTON, Calif., March 24, 2026 /PRNewswire/ -- Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the launch of the cobas® eplex respiratory pathogen panel 3 (RP3), a new diagnostic test designed to detect a broad spectrum of viruses and bacteria that cause respiratory illness. The test is now available in countries accepting the CE mark.Roche (PRNewsfoto/Roche | Diagnostics Information)
Differential diagnosis of respiratory infections can be complex because many of the viruses and bacteria associated with respiratory infections may cause very similar symptoms. For vulnerable populations, including the elderly, young children, and those with weakened immune systems, a respiratory infection can quickly become life-threatening.
"In respiratory care, time is everything. Knowing exactly what is making a patient sick allows clinicians to make fast, effective decisions that can save lives," said Josh Lauer, Global Head of Molecular Labs at Roche Diagnostics. "We are providing hospitals with a powerful tool to manage the complexity of respiratory infections, ensuring that patients — especially those at high risk — get the targeted care they need without delay."
The cobas eplex RP3 panel provides critical support to healthcare providers during peak respiratory seasons, which are the most demanding times of the year. The new test detects more than 20 different viral and bacterial pathogens simultaneously. This helps clinicians quickly pinpoint the exact cause of a patient's illness, allowing them to start the right treatment sooner, implement adequate infection and transmission control measures, and, in some cases, avoid unnecessary antibiotic use and improve patient prognosis.
With less than one minute of hands-on time required to start the test, it is incredibly easy for laboratory staff to use. With ease of use and fast time to results, the cobas eplex RP3 panel can help reduce the time patients spend in the emergency room and allows hospitals to better manage isolation beds, keeping infectious patients separate from others.
About the cobas eplex RP3 Panel
The cobas eplex respiratory pathogen panel 3 is a qualitative in vitro diagnostic test aimed at the simultaneous detection and differentiation of up to 25 viral and bacterial targets. It runs on the cobas eplex system, a platform designed to simplify laboratory workflow with features like automated result reporting and external control tracking & monitoring. Like the RP2 panel, the RP3 panel detects common pathogens, such as influenza virus A and B, RSV, SARS-CoV-2,, plus new pathogens including Bordetella parapertussis and Chlamydia pneumoniae that can cause severe illness in high risk patients. The cobas eplex RP3 panel also has updated inclusivity for influenza virus and SARS-CoV-2 to ensure coverage of current and recently circulating strains. This test is also the first in the cobas eplex family to feature flexible syndromic testing, giving the option to labs to customise up to 5 distinct panels based on local prevalence needs or unique patient presentations.
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About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
For further information please contact
Yvette Petillon, Group Media Relations
Phone: +41 79 961 92 50
e-Mail: yvette.petillon@roche.com
Brien Mahoney, Molecular Labs Communications
Phone: +1 925 699 8512
e-Mail: brien.mahoney@roche.comCision
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- Roche inaugurates new research home for the Institute of Human Biology, pioneering human model systems to accelerate drug discovery and development
Mar 23, 2026
F. Hoffmann-La Roche Ltd
The new building is part of a CHF 1.4 billion site investment, reinforcing Roche’s commitment to Switzerland and the Basel life sciences cluster The Institute of Human Biology (IHB) enables scientists to pioneer human model systems, accelerating the development of new medicines to improve the lives of patients Federal Councillor Elisabeth Baume-Schneider, Head of the Federal Department of Home Affairs (FDHA), will attend the official opening ceremony
Basel, 23 March 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the inauguration of the new research home for the Institute of Human Biology. The opening marks a significant milestone in Roche’s strategy to unlock the transformative potential of human model systems to revolutionise the future of drug discovery and development.
Thomas Schinecker, CEO of the Roche Group: “The inauguration of the Institute of Human Biology reinforces our commitment to Switzerland as a global innovation hub, where Roche invests around CHF 3.5 billion in research each year. By combining human organoid models with artificial intelligence, IHB has the potential to change how we discover and develop new medicines — making research and development more predictive and more efficient. Together with our partners, we aim to bring innovative treatments to patients faster.”
Azad Bonni, Global Head and Director of the Institute of Human Biology: “Modern medicine requires sophisticated technologies. By pioneering human model systems and better understanding human disease, we will move beyond the limitations of traditional research to predict if and how new treatments will work in people. This new research facility allows our scientists to make and translate discoveries at the intersection of fundamental and industry sciences, changing how we understand and tackle human disease."
IHB leverages human disease biology, computational biology and translational bioengineering to pioneer advanced systems that replicate human disease biology with unprecedented precision. Bringing this diverse expertise together across multidisciplinary projects allows scientists the chance to generate sophisticated models, such as complex cultured tissue samples, organoids, microfluidic 'organ-on-chip' technologies and in silico modelling. These models are deepening our understanding of the fundamental mechanisms of human disease and therapeutics and transform the future of R&D.
Building 92 will house up to 250 researchers and provide a collaborative environment designed to bridge the gap between fundamental and industry sciences. It includes modular laboratories that will allow sustainable growth and foster interdisciplinary exchange.
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Roche is currently investing CHF 1.4 billion in the site development in Basel & Kaiseraugst. Since 2016, Roche has invested approximately CHF 7 billion into its Swiss sites. Furthermore, Roche has invested CHF 33 billion in research and development in Switzerland since 2016, resulting in a total investment of around CHF 41 billion over the last decade (2016 to 2025).
About the Institute of Human Biology Roche’s Institute of Human Biology (IHB), based in Basel, was founded in 2023 and is a global leader in developing and engineering next-generation human model systems, such as advanced tissue cultures, organoids, organoids-on-chips, and in silico modelling to better understand human disease and accelerate the development of new therapeutics and diagnostics. Human model systems are simple representations of human tissues that also have the potential to reduce reliance on animal testing. The institute leverages its unique setup, multidisciplinary expertise and new state-of-the-art facility in Building 92 to foster innovative collaborations and stay at the forefront of biomedical research. By bridging basic research discovery and industry application, the institute will facilitate the rapid translation of groundbreaking science into patient-focused solutions.
For more information, please visit institutehumanbiology.com.
About Building 92 For more information on Building 92, please refer to the fact sheet.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com
Hans Trees, PhD
Phone: +41 79 407 72 58 Nathalie Altermatt
Phone: +41 79 771 05 25 Lorena Corfas
Phone: +41 79 568 24 95 Simon Goldsborough
Phone: +44 797 32 72 915 Karsten Kleine
Phone: +41 79 461 86 83 Kirti Pandey
Phone: +41 79 398 38 53 Yvette Petillon
Phone: +41 79 961 92 50 Dr Rebekka Schnell
Phone: +41 79 205 27 03
Attachment
Media Release IHB B92 Inauguration English
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- Can Anktiva's Label Expansion Unlock the Next Growth Phase for IBRX?
Mar 23, 2026
ImmunityBio’s IBRX growth narrative is increasingly tied to the expansion potential of its sole marketed drug, Anktiva, beyond its initial approval in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). While the current label establishes a commercial foothold, the company is advancing multiple clinical programs aimed at extending the therapy’s use across broader oncology indications.
ImmunityBio is evaluating Anktiva in several clinical studies spanning solid tumors and hematologic malignancies as part of its broader Cancer BioShield platform strategy. Under this approach, the therapy acts as a backbone immunotherapy designed to stimulate immune cells such as natural killer (NK) cells and T cells.
Within bladder cancer, IBRX is advancing a randomized study evaluating Anktiva plus BCG in BCG-naïve NMIBC patients — a significantly larger population than the currently approved setting. The company is targeting a potential regulatory filing in the near term, with additional studies exploring the therapy across other disease settings that could further expand its addressable market.
Beyond bladder cancer, ImmunityBio is exploring Anktiva in combination with standard-of-care therapies and CAR-NK approaches across several difficult-to-treat cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, glioblastoma, colorectal cancer and hepatocellular carcinoma.
Successful development across the above -mentioned clinical studies could position Anktiva as a foundational immunotherapy platform for multiple cancer types, potentially supporting additional regulatory filings and long-term growth if clinical outcomes remain encouraging.
IBRX Faces Intense Competition in Target Markets
ImmunityBio faces stiff competition from Big Pharma in its target markets.
The company competes with well-established immunotherapies such as Merck’s MRK Keytruda, Bristol Myers’ BMY Opdivo and Roche’s RHHBY Tecentriq. These drugs are already widely used across several oncology indications, including those targeted by IBRX.
Beyond having approved therapies, these pharma giants possess significantly greater financial resources, extensive global commercial infrastructure and well-established supply chains. Their long-standing presence in oncology gives them deep clinical development experience and strong relationships with physicians and treatment centers. This could make market penetration more challenging for newer entrants like ImmunityBio.
IBRX’s Price Performance, Valuation and Estimates
Shares of ImmunityBio have outperformed the industry year to date, as seen in the chart below.
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From a valuation standpoint, IBRX is trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 34.40 times forward 12-month sales, above the industry average of 1.99 times.Zacks Investment Research
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Estimate movements for ImmunityBio’s 2026 and 2027 EPS have been mixed during the past 60 days.Zacks Investment Research
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ImmunityBio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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- Why The Roche Holding (SWX:ROG) Narrative Is Shifting On Mixed Pipeline Signals And Valuation
Mar 22, 2026
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Roche Holding’s updated fair value estimate has shifted from CHF 358.45 to CHF 363.47, a modest move that keeps the focus on how the story is evolving rather than on a sweeping reset. That small change sits alongside a split in recent analyst views, with some pointing to potential upside and others holding back due to pipeline timing and trial questions. As you read on, you will see how these differing opinions shape the narrative and what to watch to stay on top of it.
Stay updated as the Fair Value for Roche Holding shifts by adding it to your watchlist or portfolio. Alternatively, explore our Community to discover new perspectives on Roche Holding.
What Wall Street Has Been Saying
🐂 Bullish Takeaways
Barclays upgraded Roche to Overweight from Equal Weight with a CHF 390 price target, highlighting what it calls an attractive setup for 2026 clinical catalysts and an undemanding valuation. Goldman Sachs upgraded Roche to Neutral on what it describes as improved growth potential, signaling more constructive sentiment after previous caution. Berenberg raised its price target to CHF 340 from CHF 320 while keeping a Hold rating, reflecting a more supportive stance on the shares despite only a moderate adjustment. HSBC, while trimming its price target to CHF 365 from CHF 385, suggested healthcare could appeal to investors given macro and geopolitical risks and lower exposure to AI related disruption.
🐻 Bearish Takeaways
BNP Paribas downgraded Roche to Neutral from Outperform and reduced its estimates after recent pipeline updates, pointing out that major clinical updates are not expected until 2027. JPMorgan lowered its price target to CHF 325 from CHF 350 and kept a Neutral rating, underscoring a more cautious stance on valuation and execution while key trials and readouts remain further out.
Do your thoughts align with the Bull or Bear Analysts? Perhaps you think there's more to the story. Head to the Simply Wall St Community to discover more perspectives!SWX:ROG 1-Year Stock Price Chart
We've flagged 1 risk for Roche Holding. See which could impact your investment.
What's in the News
The U.S. FDA classified Roche's Ionify steroid assays on the cobas Mass Spec solution as CLIA moderate complexity. This allows more routine clinical labs to run mass spectrometry based testing. Roche reported mixed phase III persevERA data in ER positive, HER2 negative metastatic breast cancer, with no statistically significant progression free survival benefit but a numerical improvement versus letrozole plus palbociclib. Development of giredestrant is continuing. Roche and Genentech, together with Zealand, released positive Phase II ZUPREME 1 results for petrelintide in obesity. The study showed up to 10.7% mean weight loss at 28 weeks versus 1.7% with placebo and a favorable tolerability profile. Phase II data for CT 388, a dual GLP 1/GIP agonist for obesity, showed placebo adjusted weight loss of 22.5% at 48 weeks on the efficacy estimand and low discontinuation rates. Further data are planned for presentation at a medical congress, and the Chairman also flagged potential future U.S. tariffs on the diagnostics division after a 150 day grace period.
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How This Changes the Fair Value For Roche Holding
Fair value has moved from CHF 358.45 to CHF 363.47, representing a small upward adjustment to the model output. Revenue growth assumptions have been reduced from 2.71% to 2.18% in CHF terms. The assumed net profit margin has moved from 26.05% to 25.63% on CHF revenues. The future P/E multiple has risen from 17.84x to 18.67x, which contributes more to the updated fair value. The discount rate remains unchanged at 3.91%, so rate and risk assumptions are the same.
Never Miss an Update: Follow The Narrative
Narratives connect Roche Holding's clinical, commercial, and policy story to a set of financial assumptions and a fair value estimate. They update as new trial results, pricing changes, or regulatory decisions come through, so you can see how the investment case evolves over time.
Head over to the Simply Wall St Community and follow the Narrative on Roche Holding to stay up to date on:
How expanding diagnostics platforms, AI tools, and high value biologics in oncology, immunology, and neurology feed into future revenue and margin assumptions. What analysts are incorporating for obesity assets like petrelintide and CT 388, the targeted cost savings of CHF 3b by 2030, and a shift toward newer, less patent sensitive medicines. Key pressure points, including China pricing reforms, upcoming patent expiries on major biologics, biosimilar competition, and the impact of healthcare cost controls on profitability.
This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include ROG.SW.
Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com
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- Prothena Partners Present Data Supporting Next Generation Treatments for Parkinson’s and Alzheimer’s Disease at AD/PD™ 2026
Mar 21, 2026
DUBLIN, March 21, 2026--(BUSINESS WIRE)--Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced partner presentations on clinical updates from prasinezumab for the treatment of Parkinson’s disease and BMS-986446 for the treatment of Alzheimer’s disease at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2026) in Copenhagen, Denmark, and online.
Roche Presentations on Prasinezumab for the Potential Treatment of Parkinson’s Disease
Industry Symposium – Pathways to Progress: Exploring Innovations in AD and PD for Future Practice
Chair: Malú G. Tansey, Ph.D., Indiana University School of Medicine Stark Neuroscience Institute Date: Tuesday March 17, 2026
This symposium reviewed the evolving understanding of the molecular pathophysiology and disease heterogeneity across Alzheimer's disease (AD) and Parkinson's disease (PD). Explored current and emerging treatment pathways, e.g. alpha-synuclein, amyloid-beta and neuroinflammation; including diagnostics, biomarkers and therapeutics. Considered how the advancing understanding of AD and PD informs innovative clinical development approaches and clinical practice.
Oral Presentation – Modeling Parkinson’s Disease Progression to Quantify Long-Term Treatment Effects via the Concept of ‘Time Saved’
Presenter: Benjamin Ribba, Roche Date: Thursday March 19, 2026
The comparison of PASADENA open-label extension (OLE) data with PPMI-based model predictions supports potential disease-modifying efficacy with an estimated two years of ‘time saved’ providing an intuitive measure of long-term benefit. The observed PASADENA OLE outcomes consistently deviated from the model-predicted progression, suggesting a sustained treatment effect. On average, participants were approximately two years less advanced in disease severity five years after the start of the trial compared to the virtual comparator.
Oral Presentation – Prasinezumab in Early-Stage Parkinson’s Disease: Additional Data from the PADOVA Study
Presenter: Tania Nikolcheva, M.D., Ph.D., Roche Date: Saturday March 21, 2026
Longer term data from the PADOVA OLE study in early-stage PD showed a sustained effect of prasinezumab in slowing Parkinson’s progression on top of effective symptomatic therapies. The totality of the evidence suggests a possible clinical benefit of prasinezumab and informed the initiation of the Phase III PARAISO study.
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Poster Presentation – Prasinezumab’s Impact on Neuromelanin- and Iron-Sensitive MRI Biomarkers in Parkinson’s Disease: Findings from the PADOVA Phase IIb Study
Exploratory biomarker analysis of PADOVA suggests that prasinezumab is biologically active. This is supported by imaging biomarkers crucial to PD pathology, showing a slowing in the progressive loss of neuromelanin signal in substania nigra pars compacta and reduced iron accumulation in the putamen.
Poster Presentation– Sustained Effect on Prasinezumab on Parkinson’s Disease Motor Progression in the Open-Label Extension of the PASADENA Trial, 5-Year Update
At Year 5, the combined PASADENA arm (delayed- and early-start groups) showed less disease progression compared to the PPMI cohort. This lower progression was observed across multiple measures.
Poster Presentation– Digital Health Technology Detects Group Differences in Practically-Defined OFF L-DOPA State: Results of PADOVA Phase IIb Study of Prasinezumab
Post-hoc Digital Health Technology analyses showed consistent trends favoring prasinezumab in digital data collected in the practically-defined OFF L-DOPA state, in line with the PASADENA Phase 2a Simple Sum digital finding and clinical PADOVA readout.
Bristol Myers Squibb Presentation on BMS-986446 for the Potential Treatment of Alzheimer’s Disease
Oral Presentation– Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BMS-986446 in Healthy Participants, Including Those of Japanese Ethnicity
Presenter: Ilena George, M.D., Bristol Myers Squibb Date: Saturday March 21, 2026
Single-dose BMS-986446 was safe and well tolerated in all participants, including those of Japanese ethnicity. Plasma exposure of BMS-986446 increased dose proportionally. No anti-drug antibodies were detected. These results support BMS-986446 dosing in ongoing clinical studies without adjustments for Japanese ethnicity.
About Prasinezumab
Prasinezumab is an investigational monoclonal antibody designed to bind aggregated alpha-synuclein and thereby reduce neuronal toxicity. By reducing the build-up of alpha-synuclein protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, which may slow progression of the disease.
About Parkinson’s Disease
Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease characterized by the gradual loss of neurons that make dopamine and other nerve cells. Today, Parkinson’s disease affects over 10 million people worldwide. The prevalence of Parkinson’s disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available. However, no therapies slow down or stop the clinical progression of Parkinson’s disease.
About BMS-986446
BMS-986446 is a humanized monoclonal antibody that targets multiple domains of the microtubule binding region of tau, a highly pathogenic tau fragment associated with neurofibrillary tangle formation and cognitive decline in Alzheimer’s disease. BMS-986446 binds to specific regions of the tau protein (R1–R3 within the microtubule-binding domain) to stop cell-to-cell spread of tau and tau uptake into cells. It also activates microglia—the brain’s immune cells—through its Fc receptor function, promoting the clearance of tau via phagocytosis.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive, multifaceted and devastating neurodegenerative disease and the most common type of dementia in adults. Changes in the brain disrupt communication between neurons, impacting memory, cognition and behavior. As a result, Alzheimer’s disease has a significant impact on the day-to-day lives of those it directly affects, as well as on their families, caregivers and friends, resulting in considerable shifts in interpersonal relationships. There remains a critical need for disease-modifying therapies that can slow or delay the progression of Alzheimer’s disease as well as therapies that manage and ease neurobehavioral symptoms.
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including Parkinson’s disease, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS) and a number of other neurodegenerative diseases. Prothena is developing and applying CYTOPE®, a novel technology that incorporates a cell-internalizing domain to drive efficient cytosolic delivery with highly specific macromolecular effectors. For more information, please visit the Company’s website at www.prothena.com and follow the Company on X (formerly Twitter) @ProthenaCorp.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential, designs, proposed mechanisms of action, and potential administration of prasinezumab and BMS-986446; and the continued advancement of our preclinical and clinical pipeline, including the potential and advancement of CYTOPE. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, as well as those described in the "Risk Factors" sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 27, 2026, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260321254343/en/
Contacts
Mark Johnson, CFA
Senior Vice President, Head of Investor Relations and Corporate Communications
650-837-8550
IR@prothena.com
Media@prothena.com
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- Sarepta Plans FDA Filings Seeking Full Approval for Two DMD Therapies
Mar 20, 2026
Sarepta Therapeutics SRPT announced plans to submit supplementary new drug applications (sNDAs) to the FDA for its two RNA-based PMO therapies — Amondys 45 and Vyondys 53 — by the end of next month. These filings seek to convert the therapies’ accelerated approval into full/traditional approvals.
Both therapies were previously granted accelerated approval to treat patients with Duchenne muscular dystrophy (DMD) based on increases in dystrophin production. Sarepta now intends to support the sNDAs with additional data, including real-world evidence, as part of its effort to confirm clinical benefit.
Amondys 45 was approved in 2021, while Vyondys 53 received approval in 2019. Both are currently approved under the FDA’s accelerated pathway for DMD patients amenable to exon 45 or 53 skipping.
This update follows challenges with the confirmatory study, which did not meet its primary endpoint. The FDA will evaluate the totality of evidence, including both clinical and real-world data, to determine whether the therapies meet the requirements for traditional approval.
Details From Sarepta’s Confirmatory Study
In November, Sarepta announced the completion of the phase III ESSENCE study, which evaluated the safety and efficacy of Amondys 45 and Vyondys 53 compared to placebo in DMD patients aged 6-13 who are amenable to exon 45 or 53 skipping. While the company noted positive numerical trends favoring both therapies at 96 weeks, the study did not achieve statistical significance on its primary endpoint.
Sarepta attributed the lack of statistical significance, in part, to the COVID-19 pandemic, stating that when COVID-affected data were excluded, a meaningful treatment effect on the primary endpoint was observed. The ESSENCE study reaffirmed a favorable safety profile for both therapies.
Some investors viewed the update as encouraging, as it suggests a potential pathway for the therapies to pursue full approval despite the confirmatory study not meeting its primary endpoint.
SRPT Stock's Performance
In the past year, shares of Sarepta have plunged nearly 78% against the industry’s 11% growth.Zacks Investment Research
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Will Sarepta’s Stock Head Toward Recovery?
Last year, Sarepta faced significant investor concerns after three patient deaths were linked to its gene therapy treatments and attributed to acute liver failure (ALF). While two deaths occurred in patients after receiving the DMD gene therapy Elevidys, one was caused by an experimental limb-girdle muscular dystrophy (LGMD) therapy. All deaths occurred in non-ambulatory patients and were linked to the AAVrh74 gene therapy vector used in both Elevidys and Sarepta’s experimental LGMD therapies.
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Based on these events, the FDA approved significant changes to the label of Elevidys last November. Under the revised label, the gene therapy is now approved only for ambulatory patients aged four years and older with DMD. It is no longer authorized for use in non-ambulatory patients. Elevidys is mandated to carry a boxed warning — the most important safety warning issued by the FDA — highlighting the risks of ALF and acute liver injury (ALI).
Following these setbacks, Sarepta paused the development of most of its LGMD pipeline and shifted focus to the siRNA programs, which were acquired last year as part of a multi-billion-dollar licensing deal with Arrowhead Pharmaceuticals ARWR.
Sarepta has been trying to ease investor sentiment toward its stock. Earlier this week, the company announced that screening and enrollment are underway in a cohort of the phase Ib ENDEAVOR study. This cohort is designed to improve the safety profile of Elevidys in non-ambulatory patients by combining it with an enhanced sirolimus-based immunosuppressive regimen.
Data from this cohort will be used to determine whether administering sirolimus before or after Elevidys infusion can help reduce the risk of acute liver complications. Sarepta plans to enroll around 25 non-ambulatory patients with DMD in the United States who will receive the immunosuppressive regimen. This will include 14 days of sirolimus dosing before Elevidys infusion, followed by 12 weeks of treatment after infusion.
The company developed Elevidys in partnership with pharma giant Roche RHHBY. In 2019, Sarepta and Roche entered into a licensing agreement to develop Elevidys. Per the agreement, Roche has exclusive rights to launch and market the therapy in non-U.S. markets.
Sarepta Therapeutics, Inc. PriceSarepta Therapeutics, Inc. Price
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SRPT’s Zacks Rank
Sarepta currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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- Liquid Biopsy Products Market Report 2026-2031 Featuring Analysis of Roche, Illumina, Qiagen, MDxHealth, Novogen, BGI, Myriad Genetics and More
Mar 20, 2026
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Dublin, March 20, 2026 (GLOBE NEWSWIRE) -- The "Liquid Biopsy Product Market Report: Trends, Forecast and Competitive Analysis to 2031" has been added to ResearchAndMarkets.com's offering.
The global liquid biopsy product market is expected to grow with a CAGR of 12.4% from 2025 to 2031. The major drivers for this market are the increasing demand for non-invasive cancer diagnostics, the rising adoption of precision oncology testing, and the growing investment in advanced molecular diagnostics.
Key Highlights by Segment
Within the type category, ctDNA is expected to witness higher growth over the forecast period. Within the application category, third-party laboratory is expected to witness higher growth. In terms of region, APAC is expected to witness the highest growth over the forecast period.
Emerging Trends in the Liquid Biopsy Product Market
The liquid biopsy product market is undergoing significant transformation driven by technological advancements, a shift towards personalized medicine, and increasing demand for minimally invasive diagnostics. Key trends shaping the market include:
Technological Advancements: Integration of next-generation sequencing (NGS) and digital PCR technologies for better sensitivity and specificity. Increased Oncology Adoption: Non-invasive cancer detection and monitoring, enhancing personalized oncology. Focus on Early Detection: Surge in research for early cancer diagnosis using biomarkers. Diversification: Application expansion into non-oncological fields such as infectious diseases and prenatal testing. Regulatory and Reimbursement Support: Enhanced approval and reimbursement frameworks facilitating market growth.
In summary, these trends are driving adoption and transforming patient care by improving diagnostic accuracy and expanding clinical applications.
Recent Developments in the Liquid Biopsy Product Market
The liquid biopsy product market continues to advance with notable developments such as improvements in detection methods using NGS and digital PCR, expanding disease applications, and the integration of AI and big data for better diagnostics. Additionally, the emergence of companion diagnostics and growing clinical settings are pivotal. Collectively, these innovations enhance reliability and accessibility while broadening the market's scope.
Strategic Growth Opportunities in the Liquid Biopsy Product Market
Exciting growth opportunities abound in various fields including oncology, prenatal testing, and infectious disease detection, driven by the benefits of minimally invasive diagnostics. Personalized medicine and companion diagnostics offer further potential, with each enhancing clinical outcomes and treatment precision.
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Liquid Biopsy Product Market Drivers and Challenges
Market growth is propelled by advancements in molecular diagnostics and personalized medicine, increasing healthcare expenditure, and favorable regulatory conditions. However, challenges include high costs, technical limitations, and complex regulatory landscapes. Addressing these challenges is paramount for advancing market potential and ensuring broader clinical adoption.
Country-Wise Outlook for the Liquid Biopsy Product Market
Geographical variations affect market growth due to factors like healthcare infrastructure and regulatory environments:
United States: Leads in innovation and regulatory approvals with expansive application in oncology. China: Focused on cost-effective solutions and personalized medicine due to its large population. Germany: Strong precision medicine focus with collaborations enhancing technology development. India: Emerging market with low-cost innovations aimed at improving accessibility. Japan: Technological advancements and supportive regulatory environment driving application expansion.
Overall, countries are investing in R&D to harness the potential of liquid biopsies, with each contributing to global market expansion through innovation and strategic collaborations.
Companies Profiled:
Roche Illumina Qiagen Guardant Health MDxHealth Pathway Genomics NeoGenomics Laboratories Novogen BGI Myriad Genetics
For more information about this report visit https://www.researchandmarkets.com/r/k4y42j
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- Long-only funds are buying non-US stocks, BofA says
Mar 19, 2026
Investing.com -- Long-only investors shifted decisively toward non-U.S. equities in February, according to a new note from Bank of America.
Quant strategist Nigel Tupper wrote that “long-only funds globally bought non-US stocks but sold US stocks,” marking a clear divergence in regional positioning.
BofA noted that combined active and passive funds recorded their largest inflows into Emerging Markets, purchasing over $17.6 billion, followed by Asia Pac at over $14.9 billion.
In contrast, the biggest outflows were in the United States, where funds sold $69.5 billion in shares.
By sector, the strongest buying occurred in Consumer Staples at more than $7.9 billion and Materials at over $5 billion, while Software and Media saw heavy selling of $17.7 billion and $11 billion, respectively.
The note said the world’s largest long-only stock purchases last month included Walmart, AbbVie, Roche and ASML, while major sales included AstraZeneca, Microsoft, Apple and NVIDIA.
BofA highlighted that the most widely held stocks globally by long-only funds remain TSMC at 92 percent ownership, followed by ARM at 88 percent, Microsoft at 84 percent, NVIDIA at 74 percent and Tencent at 72 percent.
The bank also said “Crowded Positives,” which are names combining high ownership and positive “Triple Momentum”, continue to outperform.
These currently include Broadcom, TSMC, Samsung Electronics, Micron Technology, SK Hynix and Eli Lilly.
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- Can Alnylam's Pipeline Drugs Sustain Long-Term Growth Ahead?
Mar 19, 2026
Alnylam Pharmaceuticals ALNY currently markets four approved drugs — Onpattro, Givlaari, Oxlumo and Amvuttra — that together generated $2.99 billion in net product revenues, representing a 81% year-over-year increase in 2025. The company also recognizes collaboration revenues from its partners like Regeneron REGN, Roche, Novartis and Sanofi, which add to the top line. ALNY’s partnership with Novartis added a fifth approved product, Leqvio. Royalty revenues from its sales have been boosting top-line growth.
To sustain long-term growth, Alnylam has made significant investments to build a broad and promising pipeline capable of driving future revenues. The company is currently advancing several candidates, with key programs including cemdisiran, mivelsiran and zilebesiran.
In 2024, Alnylam granted Regeneron exclusive rights to develop cemdisiran as a monotherapy and in combination with anti-C5 antibodies for complement-mediated indications. Regeneron is evaluating cemdisiran in combination with pozelimab, in a phase III clinical study for paroxysmal nocturnal hemoglobinuria and as a monotherapy and in combination with pozelimab in phase III clinical studies for myasthenia gravis (MG) and geographic atrophy. In 2025, Regeneron reported that cemdisiran monotherapy achieved both the primary and key secondary endpoints in the phase III study for generalized MG and plans to submit a regulatory filing seeking its U.S. approval soon, pending FDA discussions. Subject to approval, Alnylam will earn royalties on the drug’s sales, per their agreement.
Alnylam’s phase II KARDIA program showed that zilebesiran, an RNAi therapy targeting angiotensinogen, was effective both as a standalone treatment and in combination with standard antihypertensive drugs, highlighting its potential as a best-in-class option for patients with high cardiovascular risk. Additional positive results from the KARDIA-3 study, conducted with Roche, demonstrated sustained reductions in systolic blood pressure, improved cardiovascular and renal biomarkers, and a favorable safety profile, with the 300 mg dose showing the strongest benefits.
Based on such results, the companies have initiated dosing in the global phase III ZENITH cardiovascular outcomes study in 2025, which is evaluating the potential of zilebesiran to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension.
Alnylam is developing its wholly-owned pipeline candidate, mivelsiran (formerly ALN-APP), for treating early-onset Alzheimer’s disease (AD) and cerebral amyloid angiopathy (CAA). The company expects to initiate a phase II study on mivelsiran for AD in the first half of 2026. Additionally, patient enrollment and dosing are currently ongoing in a separate phase II study of the candidate for CAA.
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The continued progress of these and several other clinical-stage pipeline candidates, alongside Alnylam’s marketed therapies, has the potential to meaningfully expand and diversify its commercial portfolio.
ALNY’s Market Competition for Lead Drug Amvuttra
Alnylam’s primary top-line driver is its newest drug, Amvuttra, which is approved for polyneuropathy of hereditary transthyretin-mediated amyloidosis and ATTR amyloidosis with cardiomyopathy in adults. The drug generated $2.31 billion in global sales in 2025, representing a staggering 138% year-over-year growth, driven by patient demand.
Alnylam’s Amvuttra faces notable competition in the ATTR-CM market from Pfizer’s PFE Vyndaqel/Vyndamax (tafamidis) and BridgeBio’s BBIO Attruby (acoramidis), both of which are already approved for this indication. While Amvuttra is positioned with a differentiated clinical profile, Pfizer’s and BridgeBio’s therapies carry the advantage of oral administration and comparatively lower list prices in the United States.
Vyndaqel is one of the key products that has driven improvement in Pfizer’s revenues in 2025. Global Vyndaqel family revenues of $6.38 billion rose 17% year over year in 2025, driven by continued demand growth. Pfizer’s Vyndaqel family includes global revenues from Vyndaqel as well as revenues for Vyndamax in the United States and Vynmac in Japan.
BridgeBio received FDA approval for Attruby in 2024. The drug generated U.S. sales worth $362.4 million in 2025, driven by increasing patient adoption and prescriber utilization. BBIO reported that as of Feb. 20, 2026, 7,804 unique patient prescriptions for Attruby have been written in the United States by 1,856 unique healthcare providers since approval. BridgeBio is also currently evaluating acoramidis for the prevention of early-stage variant transthyretin amyloidosis in a late-stage study.
ALNY’s Stock Price, Valuation and Estimates
Shares of Alnylam have plunged 31.4% in the past six months against the industry’s 14.8% growth. The stock has also underperformed the sector and the S&P 500 index during the same time frame, as seen in the chart below.
ALNY Stock Price MovementZacks Investment Research
Image Source: Zacks Investment Research
From a valuation standpoint, Alnylam stock is expensive. Going by the price/sales ratio, the company’s shares currently trade at 11.55 trailing 12-month sales per share, much higher than 2.39 for the industry. The stock, however, is trading below its five-year mean of 19.37.
ALNY Stock ValuationZacks Investment Research
Image Source: Zacks Investment Research
Estimates for Alnylam’s 2026 earnings have decreased from $10.44 to $9.57 per share in the past 60 days, and estimates for 2027 earnings have decreased from $18.15 to $15.03 over the same time frame.
ALNY Estimate MovementZacks Investment Research
Image Source: Zacks Investment Research
Alnylam currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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- NIPER Raebareli partners with Roche Pharma to Strengthen Pharmaceutical Education and Research Capability Building Collaboration
Mar 19, 2026
NEW DELHI, March 19, 2026 /PRNewswire/ -- Roche Pharma India signed a Memorandum of Understanding (MoU) with National Institute of Pharmaceutical Education and Research (NIPER) Raebareli to foster academic–industry collaboration and strengthen pharmaceutical education and research in India. The MoU was signed at the Department of Pharmaceuticals (DoP) in the presence of Shri Manoj Joshi, IAS, Secretary, DoP. Also present at the MoU signing event was Shri Awadesh Kumar Choudhary, Senior Economic Advisor, DoP and Ms. Anugraha P, Director, DoP.Roche Logo
Roche and NIPER Raebareli will work together to bridge the gap between academic learning and real-world industry practices, equipping students and faculty with insights into evolving pharmaceutical and regulatory landscapes. As part of the MoU, engagements like: A certificate program in regulatory affairs for students and industry professionals, Guest lecture series by industry experts on emerging trends in AI for pharmaceutical research, drug development and healthcare innovation, scholarship-cum-industry exposure opportunities to students at NIPER Raebareli through Roche's LEAP program, and faculty immersion programs are planned.
Speaking on the occasion, Shri Manoj Joshi, Secretary, DoP highlighted that, "India needs to develop urgent capabilities in regulatory sciences, biologics and AI in Pharma for developing sustained global competitive advantage and assert its global position. Collaborations like these between academia and industry are critical to meet those aspirations."
Speaking on the collaboration, Rajwinder (Rajji) Mehdwan, Managing Director & CEO – Roche Pharma India said, "At Roche, our vision is to be a pioneering and participative partner to strengthen India's healthcare ecosystem. Partnerships like these with NIPER Raebareli will enable a stronger industry-academia linkage for innovation and regulatory practices leading to sustained global competitive advantage for India's biopharma sector. Our collaboration aligns perfectly with the Viksit Bharat vision through mission Biopharma Shakti, helping India move from volume-led to value-led innovation."
Prof. Shubhini A. Saraf, Director, NIPER Raebareli added, "This partnership with Roche represents an important step in strengthening academic excellence and industry relevance in pharmaceutical education. Through this MoU, we aim to prepare students to meet evolving global healthcare challenges while contributing to India's growing leadership in the biopharmaceutical sector."
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Officials present at the event emphasised the importance of such collaborations strengthening India's position as a global hub for biopharmaceutical innovation. Such initiatives will help build a skilled workforce, encourage research in advanced pharmaceutical technologies for a strong and resilient healthcare system.
In February 2026, Roche Pharma had signed an MoU with NIPER Mohali to partner in the areas of curriculum design and development, student mentorship, setting up professors of practice, scholarship-cum-industry exposure opportunities to students at NIPER Mohali through Roche's LEAP program, and delivery of industry-relevant short-term courses aimed at making the students of NIPER-Mohali industry-ready professionals.
Through these MoU, the two NIPERs and Roche Pharma aim to create a collaborative industry- academia ecosystem that nurtures talent, drives innovation and supports the development of future-ready professionals for India's rapidly evolving biopharmaceutical sector.
About Roche Products (India) Pvt. Ltd.
Roche Products (India) Private Limited was incorporated in 1994 as a wholly owned subsidiary of the Roche Group, headquartered in Basel, Switzerland. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. For more information on Roche Pharma India, visit www.rocheindia.com
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