The goal of this observational study is to learn if a traditional Chinese herbal medicine (Xuanfei Jiangzhuo Decoction) works to help older adults recover from a COPD flare-up caused by the flu (influenza virus). The main questions it aims to answer are:
Does the herbal medicine help participants feel better and recover faster? Does it lower the chance of getting a second infection from bacteria? Is the herbal medicine safe to use? Researchers will compare participants who choose to take the herbal medicine along with their standard flu treatment (Oseltamivir or Baloxavir) to participants who only take the standard flu treatment (Oseltamivir or Baloxavir).
Participants will:
Take the herbal medicine (a liquid drink) twice a day for 5 days, or just take their standard flu medicine for 5 days.
Visit the clinic 4 times over 28 days for checkups and tests. Provide blood and stool samples to help researchers understand how the medicine affects the body and gut health.
Answer simple questions about their cough, breathing, and energy levels.

Start Date01 Aug 2026

Sponsor / Collaborator

Tianjin Medical University

NCT07314905

/ RecruitingPhase 3IIT

Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings

TreatResp is a double-blind, individually randomized, multi-centre adaptive platform trial. TreatResp aims to establish an adaptive platform trial aimed at evaluating the clinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics for respiratory pathogens in non-hospitalized patients. Participants will be randomized to receive usual care (i.e., supportive care and symptom relief) or a study therapeutic, which will be determined by the TreatResp Therapeutics Committee. The primary outcomes being evaluated is time to recovery.

Start Date29 Apr 2026

Sponsor / Collaborator

Unity Health Toronto

[+2]

CTR20260815

/ CompletedNot Applicable

玛巴洛沙韦片人体生物等效性研究

[Translation] Human bioequivalence study of mabaloxavir tablets

考察参比制剂与受试制剂在健康人体内的生物等效性和安全性。

[Translation]

The bioequivalence and safety of the reference formulation and the test formulation in healthy human subjects were investigated.

Start Date05 Apr 2026

Sponsor / Collaborator

Hangzhou Minsheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Baloxavir Marboxil

100 Translational Medicine associated with Baloxavir Marboxil

100 Patents (Medical) associated with Baloxavir Marboxil

425

Literatures (Medical) associated with Baloxavir Marboxil

31 Dec 2026·Emerging Microbes & Infections

TMPRSS2 inhibitors with broad-spectrum efficacy against SARS-CoV-2 (JN.1) and influenza A (H1N1) viruses protect mice from influenza A infection

Article

Author: Brown, Jack T ; Villanueva, Iván ; Ennis, Siobhan ; Pérez-Vargas, Jimena ; Bautista-Sánchez, Diana ; Olver, Syan ; Ho, Michelle ; Niikura, Masahiro ; Ferková, Sára ; Presley, Lianne ; Brinsden, Lara ; Jean, François ; Hetrick, Brian ; McCallum, Matthew ; Saintigny, Anaïs ; Thompson, Connor A H ; Leduc, Richard ; Kaushik, Nidhi ; Chen, Mike ; Boudreault, Pierre-Luc ; Veesler, David ; Warner, Bryce ; Fone, Jessica

Human TMPRSS2 is a type II transmembrane serine protease and an essential host factor for SARS-CoV-2 and influenza A virus (IAV H1N1) infections. It facilitates the cleavage of viral surface glycoproteins, which are required for membrane fusion. This importance makes it an attractive target for host-directed antiviral therapies. We previously identified N-0385 and N-0920 as nanomolar TMPRSS2 inhibitors and demonstrated their antiviral potency against several SARS-CoV-2 variants. Here, we screened another twelve N-0385/N-0920 analogs with improved pharmacokinetics. Compounds 9 and 10 showed strong inhibition of TMPRSS2 activity and viral entry: they blocked pseudoviruses and authentic SARS-CoV-2 JN.1 and IAV H1N1 in Calu-3 cells. Compound 9 displayed a synergistic effect with baloxavir during IAV H1N1 infection. Both compounds highly reduced H1N1 infection in air-liquid interface cultures and mouse models, thus highlighting their broad antiviral potential. The discovery of broad-spectrum, host-directed antivirals against current and emerging human viruses is critical in preparing for future pandemics.

31 Dec 2026·Emerging Microbes & Infections

Emergence of the novel PA-D27G mutation conferring reduced baloxavir susceptibility in influenza A viruses circulating in China, 2018–2025

Article

Author: Zhao, Xiaoyu ; Mi, Yabo ; Lu, Jian ; Ai, Jingwen ; Sun, Yulei ; Zhang, Wenhong ; Sun, Binhuang ; Tang, Wanggang ; Xue, Quanlin ; Tang, Xiaolu ; Shen, Zhouying ; Lu, Yinying ; Wang, Hongyu

Seasonal influenza A viruses evolve rapidly, yet the emergence and molecular basis of resistance to the polymerase acidic (PA) inhibitor baloxavir marboxil (BXM), which is widely used in China, remain elusive. To address this, 3938 PA gene sequences were collected from influenza patients across mainland China between 2018 and 2025, from the national surveillance network and GISAID. By screening post-market mutations in the N-terminal domain of PA (PAN) that appeared in at least two samples and at a frequency below 50%, twenty-five single-point mutations were identified and additionally six linked mutations potentially associated with drug pressure. The impact of these mutations on BXM sensitivity was subsequently evaluated. Our analysis revealed the emergence of known mutations associated with reduced BXM sensitivity, including L28P, K34R, E198 K, although their prevalence remained low (2/3850, 0.05%). Notably, we identified a novel substitution, D27G, which conferred an approximately 12.4-fold reduction in BXM susceptibility compared with the wild-type virus and exhibited higher replication fitness than the canonical resistance mutation I38T, as demonstrated in human airway organoids. Molecular dynamics simulations further indicated that PA-D27G attenuates the interaction between PA and baloxavir acid, the active form of BXM. Epidemiological analysis showed that D27G mutation remained rare, being detected in four isolates (4/1247, 0.32%) in mainland China, and at a sporadic prevalence (<0.1%, 9/53132) across global isolates. In conclusion, these results demonstrate the early emergence of BXM-associated resistance in China and identify PA-D27G as a resistance-associated mutation with preserved viral fitness, underscoring the importance of continued genomic and epidemiologic surveillance.

01 Dec 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Identification of related substances in baloxavir marboxil using 2D-LC-Q-TOF/MS

Article

Author: Cao, Xue-Ling ; Ji, Meng ; Yao, Yan-Rong ; Zuo, Li-Juan ; Song, Min ; Liu, Zhi-Tong ; Lu, Yu-Ting ; Adouani, Imene ; Hang, Tai-Jun ; Tian, Yu-Cheng

Baloxavir marboxil, a novel RNA polymerase inhibitor for the treatment of influenza, suppresses viral replication at the initiation stage of RNA transcription and has demonstrated significant clinical efficacy in reducing viral load and rapidly alleviating respiratory symptoms. Previous studies have primarily focused on its pharmacodynamics and clinical efficacy, whereas systematic investigations into its related substances (RSs) and their structural characteristics remain limited. In this study, two-dimensional liquid chromatography-quadrupole time-of-flight mass spectrometry (2D-LC-Q-TOF/MS) was employed to detect and characterize process-related impurities in the baloxavir marboxil active pharmaceutical ingredient (API) and degradation products formed in its stressed samples, in accordance with the ICH Q1A(R2) guideline. Based on chromatographic retention behavior and high-resolution MS/MS fragmentation patterns, a total of 14 impurity-related peaks were characterized, including four process-related impurities and ten degradation products. Among them, six impurities, including IMP C and five degradation products (RSs 5, 6, 8, 9 and 12), were not found in the available literature and were characterized in this study. The major degradation pathways were proposed, involving side-chain hydrolysis, oxidation of the sulfur-containing aromatic ring, and the cleavage of heterocyclic linkages. Furthermore, a preliminary genotoxicity assessment of the characterized impurities was conducted in accordance with the ICH M7(R2) guideline using in-silico (Q)SAR prediction approaches, and revealed that these related substances did not exhibit genotoxic structural alerts. The determined impurity profile of baloxavir marboxil and the evaluated impurities' potential safety risks can provide a valuable reference for its impurity control, stability evaluation, and quality risk management.

124

News (Medical) associated with Baloxavir Marboxil

19 Aug 2026

·www.biospace.com

Model Medicines Discovers the RdRp Thumb-1 Pocket as a Conserved Target for Broad-Spectrum Antiviral Development

Discovery described as a “fundamental shift in antiviral drug development” by an expert peer reviewer; serves as the basis for an armamentarium of broad-spectrum, direct-acting antivirals. SAN DIEGO — Model Medicines , an AI-first biotechnology company developing first-in-class therapeutics against multi-indication biological choke points, today announced the publication of a manuscript that establishes the RNA-dependent RNA polymerase (RdRp) Thumb-1 pocket as a conserved, druggable target for broad-spectrum antiviral development. The Thumb-1 pocket is a cryptic, allosteric site on the viral RdRp that controls an essential conformational change required for polymerase initiation. Pharmaceutical engagement traps the viral polymerase in a catalytically incompetent state, inhibiting replication. “The scientific literature states that conserved, druggable, allosteric viral biology targets do not exist,” said Daniel Haders, PhD, Founder and CEO of Model Medicines. “The broad-spectrum RdRp Thumb-1 pocket disproves decades of dogma that has influenced and continues to influence every antiviral drug program. We discovered a target the field dismissed as impossible. We did this by methodically developing a platform that allows us to do the tedious work of target discovery that others will not do or cannot do.” The preprint, “The RdRp Thumb-1 Pocket is a Conserved Target for Broad-Spectrum Antiviral Development,” is available on bioRxiv . It is accompanied by a companion preprint reporting preclinical proof of concept for MDL-001, the company’s oral, direct-acting antiviral discovered against this target. Model Medicines has been invited to present the RdRp Thumb-1 findings at IDWeek 2026 this October in Washington, D.C. “This is a highly innovative and mechanistically compelling abstract with strong novelty and potential significance for antiviral drug development,” said an IDWeek 2026 expert peer reviewer. “Demonstrates conservation of an allosteric site across viral families, directly contradicting established belief that non-nucleoside antivirals cannot achieve broad-spectrum activity. This is a fundamental shift in antiviral drug development strategy.” Model Medicines has now presented the discovery of the RdRp Thumb-1 site at IDWeek 2025 [1] , AASLD 2025 [2] , HepDART 2025 [3] , CROI 2026 [4] , ESCMID Global 2026 [5] , SERVC 2026 [6] , EASL 2026 [7] , and ASV 2026 [8] . The MDL-001 preprint has also been featured in the recent launch of the Intercept Fund , a $500 million philanthropic initiative, backed by leaders across technology and global health, including Stripe, Anthropic, the OpenAI Foundation, Jane Street, and the Flu Lab. [9] The World Is No Better Prepared for the Next Pandemic Than the Last RNA virus pandemics and epidemics occur regularly and cause widespread death and economic devastation. In the last 25 years, humanity has endured at least six major viral outbreaks: West Nile virus, SARS-CoV-1, swine-origin H1N1 influenza, MERS-CoV, Ebola, and COVID-19. [10] The COVID-19 pandemic caused an estimated 14.8 million deaths, resulted in $13.8 trillion in cumulative economic losses, and pushed 97 million people into extreme poverty. [11] [12] [13] Beyond the threat of the next pandemic, the annual toll is significant. Each winter, clinicians face a recurring tripledemic of influenza, RSV, and SARS-CoV-2 that causes hundreds of millions of infections and hundreds of thousands of deaths worldwide every year. [14] In a non-pandemic year in the U.S. alone, adults experience two to six of these respiratory viral illnesses and children approximately six to eight, at an economic cost exceeding $100 billion. [15] [16] A Parallel Crisis in the Liver and a Different Kind of Need Chronic viral hepatitis is a health crisis of comparable scale. Hepatitis B and C infections persist in 254 million and 50 million people worldwide, respectively. [17] An estimated 12–72 million people also carry hepatitis D, a satellite virus that cannot replicate without hepatitis B. [18] It is estimated that 5–15 million carry both HCV and HBV at once, yet most will never be diagnosed. Only 13% of HBV infections and 36% of HCV infections are identified globally, and fewer than 1% of co-infected patients know their status. Co-infection is not merely additive. Patients carrying both viruses are over 100-fold more likely to develop hepatocellular carcinoma than uninfected individuals. [19] Compounding the danger, every FDA-approved HCV direct-acting antiviral (DAA) carries a black box warning for the risk of hepatitis B virus (HBV) reactivation in patients with current or prior HBV infection. This reactivation can lead to fulminant hepatitis, liver failure, or death. [20] This FDA-mandated warning, added in 2016, applies to all DAA regimens, such as Epclusa, Harvoni, Mavyret, and others. Together, these gaps point to a single, persistent, and largely unaddressed need: one oral agent with broad-spectrum, direct-acting activity across the viruses that drive both crises. A Conserved Target Hidden in Plain Sight Conventional wisdom held that allosteric sites on viral polymerases are too poorly conserved to support pharmaceutical engagement beyond genotype- or species-specific activity. [21] Beclabuvir, the only approved Thumb-1 inhibitor, was developed for hepatitis C and is inactive against a diverse panel of non-HCV viruses, including poliovirus, rhinovirus, coronavirus, coxsackievirus, influenza, and HIV. [22] The Thumb-1 pocket had gone unrecognized because it is cryptic, and Beclabuvir MoA and activity data were misinterpreted. Beclabuvir’s lack of activity across viruses led to the conclusion that the pocket either did not exist or was undruggable on other viruses. This conclusion was seemingly validated because in the polymerase’s resting state the viral Λ1-loop occupies the site, rendering it invisible to conventional virtual screening. Model Medicines followed biology, rather than human dogma. Model Medicines' structural biology agent identified the pocket in viruses beyond HCV. The company then analyzed published HCV inhibitor co-crystal structures to define a fifteen-residue consensus Thumb-1 pocket. Model Medicines then aligned those residues across six coronaviruses spanning both Alphacoronavirus and Betacoronavirus genera to demonstrate that the pocket and its associated Λ1-loop are conserved across RNA viral families. Following the Science to a Novel Drug Class Model Medicines used the molecular-geometric deep-learning model, ChemPrint TM , within its peer-reviewed [23] , experimentally validated GALILEO™ drug discovery platform to find chemistry capable of engaging Thumb-1 across viral families. The company assembled a proprietary, three-tier bioactivity dataset spanning explicit HCV Thumb-1 chemistry and cross-family inhibitor scaffolds, then trained its model to separate HCV-restricted chemistry from genuinely broad-spectrum chemistry. In an accompanying preprint , Model Medicines demonstrates that MDL-001 inhibits Influenza, Coronaviruses, RSV, HCV, HBV, and HDV. MDL-001 is the first Thumb-1 inhibitor demonstrated to cross viral families. These findings establish RdRp Thumb-1 as both a conserved allosteric pocket and a druggable target built to yield successive generations of broad-spectrum, pandemic-ready therapeutics. The Discovery of Novel Druggable Targets is Rare in Virology Prior broad-spectrum drug discovery programs focused on developing nucleoside/nucleotide therapeutics that directly target the viral polymerase active site or host-targeted antivirals. None of the compounds active against these target classes have achieved broad-spectrum FDA approvals for Universal Influenza-like-Illness (ILI) or Universal Chronic Hepatitis. Few recently approved direct-acting antivirals act through clearly new target classes. Notable examples include baloxavir, an influenza cap-dependent endonuclease inhibitor, and lenacapavir, an HIV capsid inhibitor. [24] [25] RdRp Thumb-1 adds a new, broad-spectrum target to that short and commercially significant list. A New Blueprint for Drug Discovery Model Medicines broke with existing drug development paradigms to discover RdRp Thumb-1. In structure-based design, molecules are docked into a target's resolved 3D structure. This method would have failed to detect RdRp Thumb-1, because its pocket is cryptic and remains closed in the polymerase’s resting state. Conversely, similarity-based ligand approaches rank molecules by similarity to known actives and look for close chemical relatives. This method would have failed to discover broad-spectrum RdRp Thumb-1 inhibitors because the search would have kept returning the same narrow HCV-specific chemistry. To discover RdRp Thumb-1, Model Medicines fused the two paradigms. To establish the biology, the team overlaid crystal structures of the HCV RdRp Thumb-1 pocket bound to inhibitors and compared the polymerase across many viral families. This comparison confirmed that the pocket is conserved. The team then ran molecular-dynamics simulations to show how a bound drug displaces the Λ1-loop. To find the chemistry, the team used its GALILEO™ AI engine to train a geometry-aware deep-learning model on a proprietary dataset of small molecules. The model learned the features that make a molecule broad-spectrum rather than the features tied to any single virus. It identified the chemistry responsible for broad-spectrum interaction with the RdRp Thumb-1 pocket. About Model Medicines Model Medicines is an AI-first biotechnology company engineering first-in-class small molecules that target the biological linchpins underlying disease. The company’s research spans infectious disease, oncology, and inflammation, with programs designed around conserved molecular choke points that drive multiple pathologies. Model Medicines has discovered a direct-acting, non-nucleoside, broad-spectrum antiviral (MDL-001) and a potent, selective, and novel BRD4 inhibitor (MDL-4102). Its work demonstrates how large-scale computation can uncover entirely new classes of drugs once thought unreachable. Model Medicines is advancing a new generation of therapeutics that redefine what is possible in modern drug discovery. Learn more at . Media & Investor Contact Patrick O’Neill Head of Partnerships & Investor Relations media@modelmedicines.com [1] MDL-001: A Broad-Spectrum Antiviral Targeting the Thumb-1 Domain of Viral Polymerases, Open Forum Infectious Diseases, Volume 13, Issue Supplement_1, January 2026, ofaf695.084, [2] MDL-001 As A Next Generation HCV Thumb-1 inhibitor With Clinical-Stage Safety, The Liver Meeting: 2025 Abstracts. (2025). Hepatology (Baltimore, Md.), 82(S1), S1–S2308. Abstract 0088. [3] Oral Thumb-1 polymerase inhibitor MDL-001 achieves preclinical HCV and HBV proof-of-concept, including HCV/HBV co-infection and equivalence to sofosbuvir. Paper presented at: HEPDART 2025; December 7–11, 2025 [4] MDL-001, a novel oral thumb-1 polymerase inhibitor, shows efficacy in HCV/HBV in vitro and in vivo. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22–25, 2026; Denver, CO. Abstract 589. / [5] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates broad-spectrum activity against influenza viruses, respiratory syncytial virus, and SARS-CoV-2 with oral proof-of-concept in mice. Abstract presented at: ESCMID Global 2026; April 18, 2026; Munich, Germany. Abstract 5803 MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates single-agent efficacy against HCV/HBV co-infection in vitro, and achieves HCV and HBV preclinical proof-of-concept. Abstract presented at: ESCMID Global 2026; April 18, 2026; Munich, Germany. Abstract 5778. [6] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates broad-spectrum activity against influenza viruses, respiratory syncytial virus, and SARS-CoV-2 with oral proof-of-concept in mice. Paper presented at: the 18th Southeastern Regional Virology Conference (SERVC 2026), April 24–26, 2026 [7] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates efficacy against HCV/HBV co-infection in vitro, and achieves HCV and HBV preclinical proof-of-concept, including equivalence to sofosbuvir, Journal of Hepatology, Volume 84, Supplement 1, May 2026, Pages S877-S878, THU-580. (26)02352-4/abstract [8] MDL-001, an oral Thumb-1 polymerase inhibitor, demonstrates broad-spectrum antiviral activity across six viral families with oral in vivo proof-of-concept. Paper presented at: the 45th Annual Meeting of the American Society for Virology (ASV 2026), July 27–30, 2026 [9] Ransohoff, N., Petty, C., & Sok, D. (2026, June 24). Ending respiratory infections. Intercept. [10] Tian L, Qiang T, Liang C, et al. RNA-dependent RNA polymerase (RdRp) inhibitors: the current landscape and repurposing for the COVID-19 pandemic. Eur J Med Chem. 2021;213:113201. [11] Msemburi W, Karlinsky A, Knutson V, et al. The WHO estimates of excess mortality associated with the COVID-19 pandemic. Nature. 2023;613:130-137. [12] Gopinath, G. (2022, January 25). A disrupted global recovery. IMF Blog. [13] World Bank. Poverty and Shared Prosperity 2020: Reversals of Fortune. Washington, DC: World Bank; 2020. [14] Luong QXT, Hoang PT, Ho PT, Ayun RQ, Lee TK, Lee S. Potential broad-spectrum antiviral agents: a key arsenal against newly emerging and reemerging respiratory RNA viruses. Int J Mol Sci. 2025;26:1481. [15] Rossignol JF. Rethinking methods used to evaluate effectiveness of therapeutics for COVID-19 and other viral respiratory illnesses. Future Virol. 2022;17:67-69. [16] Hanage, W. P., & Schaffner, W. (2025). Burden of Acute Respiratory Infections Caused by Influenza Virus, Respiratory Syncytial Virus, and SARS-CoV-2 with Consideration of Older Adults: A Narrative Review. Infectious diseases and therapy, 14(Suppl 1), 5–37. [17] World Health Organization. Global hepatitis report 2024: action for access in low- and middle-income countries. Geneva: WHO; 2024. [18] 8. Negro F, Lok AS. Hepatitis D: A Review. JAMA. 2023;330(24):2376-2387. [19] Mavilia MG, Wu GY. HBV-HCV coinfection: viral interactions, management, and viral reactivation. J Clin Transl Hepatol. 2018;6:296-305. [20] U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA warns about risk of hepatitis B reactivating in some patients treated with certain direct-acting antiviral medicines for hepatitis C (DAAs). Silver Spring (MD): FDA; 2016 Oct. [21] De Clercq E. Strategies in the design of antiviral drugs. Nat Rev Drug Discov. 2002;1:13-25. [22] Gentles RG. Discovery of beclabuvir: a potent allosteric inhibitor of the hepatitis C virus polymerase. Top Med Chem. 2019;31:193-228. [23] Umansky TJ, Woods VA, Russell SM, Haders DJ. AmesNet: a task-conditioned deep learning model with enhanced sensitivity and generalization in Ames mutagenicity prediction. Chem Res Toxicol. 2026. Published online June 29, 2026. [24] Y., Frutos-Beltrán, E., Kang, D., Pannecouque, C., De Clercq, E., Menéndez-Arias, L., Liu, X., & Zhan, P. (2021). Medicinal chemistry strategies for discovering antivirals effective against drug-resistant viruses.. Chemical Society reviews. [25] Menéndez-Arias, L., & Gago, F. (2024). Antiviral Agents: Structural Basis of Action and Rational Design.. Sub-cellular biochemistry, 105, 745-784 .

Clinical Study

19 Aug 2026

·allsci.com

Stanford moving novel oral influenza antiviral toward IND with NIAID backing

Stanford University has received a USD 1.27 million NIAID R56 grant to advance a novel oral small molecule antiviral against influenza A virus (IAV) toward an investigational new drug (IND) application, targeting a mechanism distinct from all approved influenza therapies. The lead compound, STF-8562, inhibits the amphipathic helix (AH) motif of the IAV M2 protein — a target not addressed by oseltamivir (Tamiflu), baloxavir, or amantadine. In a mouse lethal-challenge model, the compound the researchers term an M2AH inhibitor provided 100% protection even when administered three days post-infection, a timepoint at which oseltamivir and baloxavir the grant states are ineffective. Two lead series appear to target distinct aspects of the M2AH motif and demonstrate synergistic activity against each other, potentially enabling combination dosing. The program's stated goals include once-daily oral dosing, IND-enabling toxicology in rats and dogs, and assembly of a full IND package for human clinical testing. The existing antiviral arsenal for IAV remains limited, with currently recommended drugs targeting either viral neuraminidase or the cap-dependent endonuclease. Adamantanes including amantadine are no longer recommended in the US because of widespread resistance among circulating influenza A viruses. STF-8562's reported activity against IAV resistant to oseltamivir, baloxavir, and amantadine, combined with its distinct M2 AH target, could therefore provide a complementary mechanism for both seasonal influenza treatment and pandemic preparedness. The one-year R56 award provides USD 1.27 million in NIAID funding for the program, which is led by principal investigator Jeffrey S. Glenn at Stanford University's Department of Microbiology and Immunology. The project began August 11, 2026, and runs through July 31, 2027, with the stated objective of advancing an M2AH inhibitor toward an IND application. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

23 Jul 2026

·www.biospace.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc

Group sales were +6% at constant exchange rates (CER) 1 , -2% when reported in CHF and +8% in USD 2 , in the first six months, driven by high demand for innovative medicines and diagnostics. Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers. Diagnostics Division sales were +3% at CER, -3% when reported in CHF and +6% in USD, driven by demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. Core operating profit was +10% at CER, -1% when reported in CHF, driven by higher sales and other revenue; IFRS operating profit was -6% in CHF due to the appreciation of the Swiss franc. Core earnings per share were +9% at CER (-2% in CHF); IFRS diluted earnings per share were -8% in CHF due to the appreciation of the Swiss franc. Highlights: US Priority Reviews for giredestrant in an early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer as well as Gazyva/Gazyvaro in idiopathic nephrotic syndrome and primary membranous nephropathy, two autoimmune diseases affecting the kidneys US acceptance of a supplemental Biologics License Application for the Lunsumio and Polivy combination for blood cancer and Gazyva/Gazyvaro for systemic lupus erythematosus Positive phase III data on divarasib in lung cancer; presentation of promising data on fenebrutinib in multiple sclerosis (phase III), Gazyva/Gazyvaro in three autoimmune diseases (phase III) and enicepatide (CT-388) and petrelintide in obesity (phase II) Launch of Axelios 1 , a transformative next-generation sequencing platform based on the innovative SBX technology, enabling the fastest DNA sequencing at scale EU CE mark for two blood tests: Elecsys pTau217 to detect Alzheimer’s pathology and Elecsys IGRA TB to identify latent tuberculosis infection US approval for Ventana PTEN (SP218) RxDx Assay , the first companion diagnostic to assess the levels of a key protein in prostate cancer Global collaboration agreement with Nurix Therapeutics for the BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement to acquire PathAI to transform AI-driven diagnostics Outlook for 2026 confirmed. Outlook for 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–June 2026 2025 At CER 1 In CHF In USD Group sales 30,364 30,944 6 -2 8 Pharmaceuticals Division 23,629 23,985 6 -1 8 Diagnostics Division 6,735 6,959 3 -3 6 Core operating profit 11,856 12,010 10 -1 Core EPS – diluted (CHF) 10.85 11.08 9 -2 IFRS operating profit 9,671 10,330 6 -6 Roche CEO Thomas Schinecker : “Our strong momentum continued in the first half of the year, driven by a 6% sales increase at constant exchange rates and significant positive pipeline development. We reported positive phase III data for divarasib , reinforcing its potential as a best-in-class therapy in advanced lung cancer. Our regulatory momentum accelerated significantly as the US FDA granted five Priority Reviews: giredestrant in early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer and Gazyva/Gazyvaro in two autoimmune kidney diseases. In Diagnostics, we reached major milestones with the launch of our transformative, highly cost-effective Axelios 1 sequencing solution, alongside EU CE mark for key diagnostic tests, including the Elecsys pTau217 blood test for Alzheimer’s pathology and the Elecsys IGRA TB blood test, which delivers automated, scalable latent tuberculosis screening to laboratories worldwide. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Backed by our robust pipeline, we are well-positioned for sustained future growth. We confirm our outlook.” Group results In the first six months of 2026, Roche sales were +6% at CER, -2% when reported in CHF, to CHF 30.4 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit was +10% at CER (-1% in CHF) to CHF 11.9 billion, driven by higher sales and other revenue. Core earnings per share were +9% at CER (-2% in CHF). IFRS operating profit was -6% in CHF to CHF 9.7 billion. IFRS diluted earnings per share were -8% in CHF. The IFRS results were impacted by the appreciation of the Swiss franc. Sales in the Pharmaceuticals Division were +6% at CER, -1% when reported in CHF, to CHF 23.6 billion, with our medicines across disease areas continuing their strong growth. The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 11.0 billion, an increase of 12% at CER, or 4% in CHF, compared to the first six months of 2025. Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) were CHF 2.6 billion, a decrease of 8% at CER, or 15% in CHF, compared to the first six months of 2025. In the United States , sales were +6% at CER, -3% when reported in CHF, due to continued growth of Xolair, Hemlibra, Polivy (blood cancer) and Tecentriq. This growth more than compensated for the lower sales of Perjeta (breast cancer) and Kadcyla (breast cancer) as well as the impact of biosimilar erosion on Actemra/RoActemra (rheumatoid arthritis). Sales in Europe were +1% at CER, or -1% when reported in CHF, as demand for Ocrevus, Evrysdi (spinal muscular atrophy) and Phesgo more than offset the impact of lower sales of Actemra/RoActemra due to biosimilar competition and Perjeta because of the conversion of patients to Phesgo. In Japan , sales were +11% at CER, -5% when reported in CHF, mainly due to product supply to third parties, as well as the uptake of Elevidys (Duchenne muscular dystrophy) and continued growth of Lunsumio (blood cancer), Vabysmo and Hemlibra. Sales in the International region were +10% at CER, or +4% when reported in CHF, led by Phesgo, Vabysmo, Hemlibra, Ocrevus and Polivy. In China, sales were -9% at CER, or -12% when reported in CHF, due to the base effect of a severe flu season in 2025 on Xofluza sales. The Diagnostics Division’s sales were +3% at CER, -3% when reported in CHF, to CHF 6.7 billion, driven by growth in demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. This growth more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region were +3% at CER, -1% when reported in CHF, driven by higher sales of immunodiagnostic products, the clinical chemistry portfolio and molecular solutions. In North America , sales were +8% at CER, -1% when reported in CHF, due to growth across the Core Lab and Pathology Lab customer areas. Sales in Asia-Pacific were -5% at CER, or -12% when reported in CHF, mainly due to the healthcare pricing reforms in China, partially offset by growth in demand for clinical chemistry and immunodiagnostic products across the rest of the region. In Latin America , sales were +10% at CER, or +5% when reported in CHF. Pharmaceuticals: key developments Compound Milestone Regulatory Gazyva/Gazyvaro Several autoimmune diseases FDA grants Priority Review for Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy (pMN) The Priority Review decision is based on results from the phase III MAJESTY study, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus. If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for pMN, following global approvals in lupus nephritis and ongoing regulatory filings in systemic lupus erythematosus and idiopathic nephrotic syndrome. pMN is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over a period of 10 years. More information: Media Release , 15 July 2026 Enspryng Thyroid eye disease FDA grants Priority Review for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED. Enspryng has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED. TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated. More information: Media Release , 30 June 2026 Lunsumio and Polivy Blood cancer FDA accepts supplemental Biologics License Application for Lunsumio and Polivy combination for relapsed or refractory large B-cell lymphoma (LBCL) Filing acceptance is based on data from the phase III SUNMO study, where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death. People with relapsed or refractory LBCL represent a population with one of the highest unmet needs in lymphoma and require timely access to effective therapies. If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment. More information: Media release , 18 June 2026 Tecentriq Colon cancer FDA grants Priority Review for Tecentriq for a certain type of stage III colon cancer Filing acceptance is based on data from the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone. Nearly one in three patients with stage III colon cancer relapses within five years, highlighting a critical need for new adjuvant treatment options. If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery. More information: Media Release , 11 June 2026 Giredestrant Breast cancer FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer, the first and only oral selective oestrogen receptor degrader with positive phase III results in the curative setting Filing acceptance, under Priority Review, is based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years. Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early stage (I‒III). The FDA has set a Prescription Drug User Fee Act date of 30 November 2026. More information: Media Release , 2 June 2026 Phase III, pivotal and other key read-outs Divarasib Lung cancer Divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer. Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed. Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population. More information: Media Release , 2 July 2026 Fenebrutinib Multiple sclerosis Fenebrutinib significantly reduces relapses versus standard of care to approximately one every 17 years in relapsing multiple sclerosis (RMS) Late-breaking phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in RMS. Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide. Fenebrutinib could become a first-in-class BTK inhibitor and the first and only high-efficacy oral medication for both RMS and primary progressive multiple sclerosis (PPMS). More information: Media Release , 22 April 2026 Other Alzheimer’s integrated portfolio presentation Roche presents new data on Alzheimer’s disease from across its integrated pharmaceuticals and diagnostics portfolio at AAIC Five oral presentations in a featured research session highlighted trontinemab, including new long-term data from the phase Ib/IIa Brainshuttle AD study and the design of phase III PrevenTRON study in preclinical Alzheimer’s disease. New data on Roche’s CE-marked Elecsys pTau217 blood test were presented on its use for the diagnosis of Alzheimer’s disease in both primary and secondary care. More information: Media Release , 7 July 2026 Nurix Therapeutics collaboration Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies. Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis). Bexobrutideg utilises a novel approach to eliminate the Bruton’s tyrosine kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors. More information: Media Release , 8 June 2026 Obesity portfolio data presentation Roche presents new data advancing its obesity portfolio at the American Diabetes Association’s 2026 scientific sessions Late-breaking phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity. Late-breaking data from the phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity. A phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated in the coming months to develop a differentiated treatment option. More information: Media Release , 1 June 2026 Oncology portfolio data presentation Roche presents new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer New data were presented from the lidERA study on giredestrant’s potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages. Primary results were presented from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease. Overall, Roche highlighted data on nine approved and investigational medicines – including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules – that target urgent needs in breast, blood, lung and other cancers. More information: Media Release , 19 May 2026 Ophthalmology portfolio data presentation Roche presents extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 New real-world data confirm the potent retinal drying of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden. Roche presented more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions. More information: Media Release , 30 April 2026 Pharmaceuticals sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Pharmaceuticals Division 23,629 23,985 100.0 100.0 6 -1 United States 12,229 12,670 51.8 52.8 6 -3 Europe 4,520 4,566 19.1 19.0 1 -1 Japan 1,360 1,425 5.8 5.9 11 -5 International 5,520 5,324 23.3 22.3 10 4 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % Ocrevus Multiple sclerosis 3,470 7 2,300 2 758 10 - - 412 30 Hemlibra Haemophilia A 2,492 11 1,313 9 502 4 171 9 506 26 Vabysmo Eye diseases (nAMD, DME, RVO) 2,059 8 1,333 1 386 5 75 26 265 65 Tecentriq Cancer immunotherapy 1,704 6 815 9 410 -3 146 -2 333 17 Xolair 3 Chronic hives, food allergies 1,673 27 1,673 27 - - - - - - Perjeta 3 Breast cancer 1,389 -7 551 -11 238 -14 24 -23 576 0 Phesgo Breast cancer 1,318 18 318 0 425 9 88 15 487 47 Actemra/RoActemra 3 RA, COVID-19 1,074 -9 515 -9 238 -21 140 8 181 -3 Evrysdi Spinal muscular atrophy 968 17 323 15 335 17 39 -1 271 25 Kadcyla 3 Breast cancer 916 -6 310 -14 248 -4 39 2 319 3 Polivy Blood cancer 808 20 381 28 128 -18 98 16 201 47 Alecensa Lung cancer 795 6 261 4 126 -4 93 8 315 13 MabThera/Rituxan 3 Blood cancer, RA 609 5 402 14 62 -9 6 -11 139 -10 Activase/TNKase 3 Cardiac diseases 555 11 531 11 - - - - 24 12 Gazyva/Gazyvaro 3 Blood cancer, lupus nephritis 489 7 240 4 117 -1 17 14 115 21 Herceptin 3 Breast and gastric cancer 462 -12 94 -14 136 -7 2 -36 230 -14 Avastin 3 Various cancer types 414 -15 125 -12 35 37 36 -44 218 -13 Pulmozyme 3 Cystic fibrosis 204 -8 145 -5 29 -11 - 26 30 -18 Columvi Blood cancer 196 70 91 28 53 116 - - 52 173 Enspryng Acute inflammation of brain, spinal cord and optic nerves 195 22 50 20 23 20 79 18 43 37 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone cobas HDV test Roche introduces cobas hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available. More information: Media Release , 14 July 2026 Elecsys IGRA TB test Roche receives CE mark for blood test to identify tuberculosis infection The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress towards the World Health Organization’s elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions. The new solution provides rapid, high-throughput and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient. More information: Media Release , 9 July 2026 Axelios 1 sequencing platform Roche announces the launch of Axelios 1, a transformative next-generation sequencing platform Axelios 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications. Powered by innovative SBX technology, the platform is capable of end-to-end, same-day whole-genome sequencing in research workflows, with accurate results within hours. The Axelios 1 platform holds promise for research laboratories today, and potentially for a broad range of clinical settings in the future. More information: Media Release , 29 June 2026 Ventana PTEN (SP218) RxDx Assay Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer The new Ventana PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with Truqap. In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments. The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalised healthcare to improve patient outcomes. More information: Media Release , 12 June 2026 Liver Disease Panel Roche launches the Liver Disease Panel, the first suite of certified algorithms to support chronic liver disease (CLD) management Roche introduces the first comprehensive library of certified healthcare algorithms to support CLD management. The Liver Disease Panel includes LiverPRO — a certified algorithm developed by the health tech company Evido — requiring only age and routine blood markers for the timely detection of liver fibrosis. With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer. More information: Media Release , 27 May 2026 Elecsys pTau217 test Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys plasma phosphorylated-tau 217 (pTau217) Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world. While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw. Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer’s disease diagnosis for millions of patients around the world. More information: Media Release , 12 May 2026 PathAI agreement Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche’s digital pathology portfolio to drive laboratory efficiency. Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools. These integrated capabilities will accelerate the shift from broad intervention towards personalised healthcare for patients. More information: Media Release , 7 May 2026 Diagnostics sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Diagnostics Division 6,735 6,959 100.0 100.0 3 -3 Customer areas Core Lab 3,756 3,839 55.8 55.2 4 -2 Molecular Lab 1,196 1,250 17.7 18.0 3 -4 Near Patient Care 909 1,018 13.5 14.6 -5 -11 Pathology Lab 874 852 13.0 12.2 11 3 Regions Europe, Middle East, Africa 2,466 2,485 36.6 35.7 3 -1 North America 2,211 2,235 32.8 32.1 8 -1 Asia-Pacific 1,522 1,729 22.6 24.9 -5 -12 Latin America 536 510 8.0 7.3 10 5 More information on Roche’s performance in the first six months of 2026: Half-Year 2026 Presentation Half-Year 2026 Presentation with appendix Half-Year 2026 Finance Report Appendix with tables 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 Pharmaceuticals 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 . All trademarks used or mentioned in this release are protected by law. References [1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025. [2] USD (US dollars). The percentage changes for selected sales figures in US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies. [3] Products launched before 2015. Cautionary statement regarding forward-looking statements This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 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 Irène Stephan Phone: +41 79 377 83 75 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 32 17 E-mail: kalm.loren@gene.com Attachments Media & Investor Release Roche HY 2026 EN Communications appendix tables_HY_Results_13072026

Clinical ResultPhase 2Phase 3Drug Approval

100 Deals associated with Baloxavir Marboxil

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KEGG	Wiki	ATC	Drug Bank
D11021	Baloxavir Marboxil	J05AX25	DB13997

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Influenza, Human	United States	Genentech, Inc.	24 Oct 2018
Influenza A virus infection	Japan	Shionogi & Co., Ltd.	23 Feb 2018
Influenza B virus infection	Japan	Shionogi & Co., Ltd.	23 Feb 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza-like symptoms	Phase 3	United States	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Costa Rica	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Israel	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Mexico	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Poland	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Russia	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Spain	Hoffmann-La Roche, Inc.	20 Nov 2018
Allergic asthma	Preclinical	China	China Pharmaceutical University	10 Feb 2024

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04712539 (Pubmed \| Antimicrob Agents Chemother)	Phase 2	Influenza, Human	6	Baloxavir + Oseltamivir	jdlxnrqyzj(kvnnocvhzn) = Baloxavir administration was well tolerated, and no adverse events could be attributed to the administered antiviral treatment bxeziphppr (vpqnstzpdi )	Negative	06 May 2026
NCT06774859 (CTgov)	Phase 3	Influenza A virus infection \| Influenza, Human	100	Baloxavir Marboxil (Baloxavir Marboxil)	likpvwjvfg = zeuundtucn vfncvckjdk (kbbggityhp, uuvidsbcda - aytxhsrgai) View more	-	27 Apr 2026
				Oseltamivir (Oseltamivir)	likpvwjvfg = kposifqequ vfncvckjdk (kbbggityhp, euxrnngxho - vlzezmnoak) View more
NCT03969212 (CENTERSTONE, CTgov)	Phase 3	Influenza A virus infection	4,138	placebo (Placebo: HHCs)	dlruqggfra = tvjbwxctjj hcxipmvfru (tjelmopqsc, hkuamrgyix - bmrngdbyxa) View more	-	24 Apr 2025
				Baloxavir Marboxil (Baloxavir Marboxil: HHCs)	dlruqggfra = udvrufwnyd hcxipmvfru (tjelmopqsc, eryjdpoasp - vtndjfgene) View more
NCT05170009 (CTgov)	Phase 2/3	Influenza, Human	2	Oseltamivir+Baloxavir Marboxil (Active and Standard of Care)	dtspybbpxy(rxehbvisda) = bzemuzinfz xzppnpmxfh (hvdjcfsist, cgkvcbhzsm - jvsmhrdybz) View more	-	26 Feb 2025
				Placebo+Oseltamivir (Placebo and Standard of Care)	oauxhsdryo = zpjtkczfji psagtnxoyj (guxnofjgcc, qpabigfxlo - zoslzzgafv) View more
NCT03969212 (CENTERSTONE, PipelineReview) Manual	Phase 3	Influenza, Human	-	Xofluza	yletuhszyt(zaixutsicz) = demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. sgttywirri (afzugfjlej ) Met View more	Positive	19 Sep 2024
NCT03653364 (CTgov)	Phase 3	Influenza A virus infection \| Influenza-like symptoms \| Influenza, Human	49	Baloxavir Marboxil	jrfytjnjux = oaurgvrmyu nxlhbxotvi (zrrarigkgq, qcltsxfsiv - cuacdduoxb) View more	-	17 May 2024
NCT02949011 (CAPSTONE-2, ASN2023)	Phase 3	Influenza, Human	1,153	Baloxavir Marboxil	czagngnpbm(ssowgporoo) = dvqpvvfnit sjemyyfjnb (lnitcyurea ) View more	Positive	02 Nov 2023
				Oseltamivir	xggevbnxxj(afbkbytqcb) = vvbalwatwd fzqxcmdwtq (soomuwxxdz ) View more
ATS2022	Not Applicable	Influenza A virus infection \| Chronic lung disease	-	Baloxavir Marboxil (BXM)	yrlalbbxjd(mmqeqyxlvg) = gnizzaxvql wneaclnqwu (gftodptlbn ) View more	-	15 May 2022
				Oseltamivir (OSL)	yrlalbbxjd(mmqeqyxlvg) = nlhejdxnoy wneaclnqwu (gftodptlbn ) View more
NCT03959332 (Pubmed \| Clin Transl Sci)	Phase 1	Influenza, Human	32	Baloxavir marboxil 40 mg	xivntlgypj(qnaldvfuer) = iyocepatuj ashlpyerio (hdrywcfnbk ) View more	Positive	17 Feb 2022
				Baloxavir marboxil 80 mg	xivntlgypj(qnaldvfuer) = lclaccvwij ashlpyerio (hdrywcfnbk ) View more
NCT03684044 (Pubmed \| Lancet Infect Dis) Manual	Phase 3	Influenza, Human	366	Neuraminidase inhibitors+Baloxavir Marboxil	frtbiwsfaq(ejosncsile) = bklpjunara hqhhxeuzwb (uzzyuiihaj, 75.9 - 117.2) View more	Negative	24 Jan 2022
				Neuraminidase inhibitors +Placebo	frtbiwsfaq(ejosncsile) = ickswtbjrg hqhhxeuzwb (uzzyuiihaj, 75.9 - 144.4) View more

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