A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 (Phosphodiesterase 5) Inhibitors

This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.
Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.
Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.

Start Date01 Aug 2010

Sponsor / Collaborator

Bayer AG

NCT01110590

/ CompletedPhase 1

Randomized, Double-blind, Placebo-controlled, Group-comparison, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administration of Different Doses of Vardenafil (2 Dose Strengths) and BAY60-4552 (4 Dose Strengths) Given Once-daily (od) Over 14 Days in Patients With Erectile Dysfunction (ED).

Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction.

Start Date01 Jan 2010

Sponsor / Collaborator

Bayer AG

NCT00565565

/ CompletedPhase 1

Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of a Single Oral Dose of BAY60-4552 in Patients With Biventricular Chronic Heart Failure and Pulmonary Hypertension in a Non-randomized, Non-blinded, Dose Escalation Design.

This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design. Furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. Several measurements will be performed to test how good the drug works and wether there are any unwanted reactions to the drug (e.g. blood tests, ECG, heart rate, blood pressure, adverse events). After a observation period the patient will be discharged from the hospital.

Start Date01 Oct 2007

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Nelociguat

100 Translational Medicine associated with Nelociguat

100 Patents (Medical) associated with Nelociguat

Literatures (Medical) associated with Nelociguat

01 Jun 2026·BIOCHEMICAL PHARMACOLOGY

Differential modulation of the sGC–cGMP pathway by sGC stimulators and activators in human lung cells

Article

Author: Cortijo, Julio ; Roger, Inés ; Ferrer-Gomez, Carolina ; Escrivá, Juan ; Montero, Paula ; Bayarri, María Amparo ; Milara, Javier

Chronic lung diseases are characterized by oxidative stress, inflammation, and fibroproliferation, conditions that impair nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic GMP (cGMP) signaling. Here, we investigated the differential effects of an sGC stimulator (riociguat) and an sGC activator (cinaciguat), alone or combined with the PDE5 inhibitor sildenafil, in primary human pulmonary cells exposed to cigarette smoke extract (CSE). Lung tissue from COPD and asthma patients displayed reduced sGC α1 and β1 expression, and CSE induced concentration-dependent oxidation of the sGC heme group, diminishing responsiveness to NO and to riociguat. Cinaciguat, but not riociguat, maintained cGMP production under oxidizing conditions, while co-treatment with sildenafil further increased cGMP levels for both drugs. In epithelial cells, fibroblasts, neutrophils, and endothelial monolayers, cinaciguat and riociguat attenuated CSE-induced oxidative stress, inflammatory cell adhesion, and profibrotic gene expression, with cinaciguat-particularly in combination with sildenafil-showing more robust effects across endpoints. These findings identify distinct pharmacodynamic profiles for sGC stimulators versus activators under oxidative conditions and support sGC modulation as a potential therapeutic approach in oxidative chronic lung diseases.

01 Aug 2025·RHEUMATOLOGY

Avenciguat: a novel soluble guanylate cyclase activator that affects multiple cell types to inhibit IFN-1 signalling and fibrosis

Article

Author: Tran-Manh, Cuong ; Zhou, Xiang ; Kaufman, Julia ; Ebenezer, David L ; Nabozny, Gerald ; Wohnhaas, Christian T ; Liebel, Christoph ; Distler, Jörg H W ; Delic, Denis ; Wang, Chao-Ting ; Trinh-Minh, Thuong ; Daley, Lee-Anne

Abstract:

Objectives:

The soluble guanylate cyclase (sGC) stimulator riociguat is approved for the treatment of pulmonary arterial hypertension and may have antifibrotic effects. However, in fibrotic tissues, oxidative stress and hypoxia can render sGC insensitive to sGC stimulators. sGC activators overcome this limitation. Here, we characterize the novel sGC activator, avenciguat, in preclinical models of SSc.

Methods:

Human microvascular endothelial cells-dermal (HMVEC-d) cultured in hypoxic conditions and activated human platelet-rich plasma were incubated with varying doses of avenciguat, and the levels of TGF-β2 and human CXC chemokine family ligand 4 (CXCL4) were measured, respectively. Treatment with avenciguat was analysed in mice with bleomycin-induced dermal and pulmonary fibrosis.

Results:

Avenciguat reduced hypoxia-induced synthesis of TGF-β2 by HMVEC-d and inhibited CXCL4 release by platelets. Moreover, avenciguat demonstrated antifibrotic effects on bleomycin-induced dermal and pulmonary fibrosis. RNA sequencing of affected skin uncovered a unique profile distinguishing avenciguat from riociguat. Avenciguat treatment resulted in deeper regulation of IFN-1 signalling and genes associated with immune response vs riociguat treatment.

Conclusion:

In preclinical studies, avenciguat shows the potential to influence vascular, fibrotic and immune-related processes in murine models of SSc. These studies suggest that it may offer therapeutic benefit across multiple aspects of SSc pathophysiology and support the rationale for further investigation in a Phase II clinical trial (VITALISScE™; NCT05559580) of avenciguat in SSc.

01 Jun 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Discovery of the first isoform-specific sGC activator: Selective activation of GC-1 by runcaciguat

Article

Author: Rühle, Anne ; Sandner, Peter ; Behrends, Sönke ; Stomberg, Svenja ; Wittrien, Theresa

Drug research and development programmes targeting soluble guanylyl cyclase (sGC) have been highly successful, leading to the launch of the sGC stimulators riociguat for pulmonary hypertension (2013) and vericiguat for chronic heart failure (2021). As the main receptor for nitric oxide, sGC plays a vital role in various physiological processes. It consists of an alpha and a beta subunit, with two distinct isoforms identified in humans: GC-1 (α₁/β₁) and GC-2 (α₂/β₁). Growing evidence indicates that these isoforms engage in different downstream signalling pathways, indicating that isoform-specific approaches could lead to novel therapeutic opportunities and reduce potential side effects. In this study, we performed concentration-response measurements with the sGC activators BAY 60-2770, BI 703704 and runcaciguat (BAY 1101042) in cell systems expressing each isoform and in purified enzymes. We found that runcaciguat selectively activated GC-1, while acting as a competitive antagonist to other activators in GC-2, without interfering with nitric oxide. BAY 60-2770 and BI 703704 activated both isoforms, albeit with varying efficacy. Our findings challenge the historical view that the two sGC isoforms are functionally indistinguishable. In fact, we demonstrate that the isoforms can be activated independently, highlighting their distinct functional profiles. Notably, runcaciguat is the first sGC activator identified to selectively target GC-1 at therapeutic concentrations. This selective targeting of isoforms not only opens avenues for new therapeutic strategies but also provides an alternative to knockout animal models for investigating isoform-specific functions.

News (Medical) associated with Nelociguat

02 Apr 2026

·www.biospace.com

Roivant Announces Expansion of Brepocitinib Development Program with New Phase 2b/3 Trial in Lichen Planopilaris (LPP) and Phase 3 Study Results for Batoclimab in Thyroid Eye Disease (TED)

Lichen planopilaris (LPP) is a highly morbid inflammatory scalp disorder that causes generally irreversible scarring hair loss, often accompanied by profound pain, itch, and burning sensations; no FDA-approved therapies exist for LPP, highlighting a critical unmet therapeutic need LPP marks the fourth indication in brepocitinib’s expanding late-stage development program Multiple lines of evidence, including strong mechanistic rationale and clinically meaningful results in an investigator-initiated placebo-controlled study of brepocitinib in LPP, support rapid development of brepocitinib in this indication A seamless Phase 2b/3 potentially registrational trial of brepocitinib in LPP enrolled its first subjects in March 2026 Immunovant’s Phase 3 studies of batoclimab in thyroid eye disease (TED) each failed to meet their primary endpoint; safety results were consistent with previous findings Patients in the TED studies demonstrated greater levels of proptosis improvement from baseline after the initial 12-week high-dose period than after the following 12-week low-dose period, supporting the benefit of deeper IgG suppression. The hyperthyroid patients in the TED studies showed similar response rates of thyroid hormone normalization to those seen in the batoclimab Phase 2 study in Graves’ disease Immunovant remains focused on rapid advancement of IMVT-1402 in multiple indications Roivant will host an investor call to discuss these updates today, April 2, 2026, at 8:00 a.m. ET BASEL, Switzerland and LONDON and NEW YORK, April 02, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced a new Phase 2b/3 clinical program for brepocitinib in lichen planopilaris (LPP), a highly morbid inflammatory scalp disorder affecting approximately 100,000 adults in the United States, and reported the topline results from Immunovant’s two Phase 3 (GO) clinical studies evaluating batoclimab as an investigational treatment for adults with active, moderate-to-severe thyroid eye disease (TED). Brepocitinib in LPP LPP inflammation targets the stem cell-rich bulge region of the hair follicle (the permanent portion responsible for hair growth), resulting in generally irreversible hair loss and permanent scarring. LPP is also associated with other burdensome symptoms, including pain, burning, itching, and scaling and an increased risk of comorbidities such as other autoimmune diseases and skin cancers. There are currently no FDA-approved therapies to treat LPP. “Lichen planopilaris (LPP) is what my colleagues and I refer to as a ‘trichologic emergency,’” said Dr. Kristen Lo Sicco, Chief of the Skin and Cancer Unit at NYU Langone Health, Board Member of the Scarring Alopecia Foundation, and Associate Professor of Dermatology at the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine. “Absent early diagnosis and aggressive intervention, patients experience rapid hair loss that is generally irreversible, leaves permanent scarring, and is often accompanied by erythema, scaling, pain, itching and burning sensations. Untreated LPP also leads to increased risk of skin cancers and other comorbidities. Efficacious FDA-approved treatments are urgently needed.” Priovant recently began enrolling subjects in a seamless Phase 2b/3 study of brepocitinib in LPP, with the first subjects enrolled in March 2026. This program marks Priovant’s fourth indication in late-stage clinical development, alongside dermatomyositis (DM), non-infectious uveitis (NIU) and cutaneous sarcoidosis (CS). The U.S. Food and Drug Administration (FDA) recently granted Priority Review to brepocitinib’s New Drug Application (NDA) for DM and assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026. Topline Phase 3 data in NIU and Phase 3 study initiation in CS are expected in the second half of calendar year 2026. “Expanding brepocitinib into lichen planopilaris continues our strategy of developing brepocitinib in highly morbid orphan conditions with limited treatment options and distinctive mechanistic benefits of dual JAK1/TYK2 inhibition,” said Ben Zimmer, Priovant CEO. “Moreover, as we look ahead to our expected product launch in DM in September, we see LPP as a strategic fit into a multi-indication rheum-derm rare disease franchise anchored by DM, with overlapping prescriber bases and thought leaders.” Immunovant Phase 3 Studies in TED Based on the pre-specified statistical analysis plan, the studies failed to meet their primary endpoint of ≥2mm proptosis responder rate at Week 24, following 12 weeks of high-dose and 12 weeks of low-dose batoclimab treatment. Safety results were consistent with previous findings, and no new safety signals were identified. Patients in the TED studies had greater levels of proptosis improvement from baseline after the initial 12-week high-dose period than after the following 12-week low-dose period, supporting the benefit of deeper IgG suppression. The subset of hyperthyroid patients in the TED studies showed similar response rates of thyroid hormone normalization to those seen in the batoclimab Phase 2 study in Graves’ disease. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402, an investigational FcRn blocker, across multiple autoimmune diseases with significant unmet need, with Graves’ disease as a key strategic priority. Recent Phase 2 proof-of-concept data highlighted FcRn blockade as a potentially disease-modifying approach in Graves’ disease. Topline data from the potentially registrational studies of IMVT-1402 in Graves’ disease are expected in calendar year 2027. Immunovant intends to review future plans for the development of batoclimab with its partner HanAll Biopharma Co., Ltd. (HanAll) and to provide an update on the program, in conjunction with HanAll, at a future date. Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, April 2, 2026, to discuss these updates. To access the conference call by phone, please register online using this registration link . The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at The archived webcast will be available on Roivant’s website after the conference call. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of JAK1 and TYK2 in development for the treatment of dermatomyositis, non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: Investors Keyur Parekh keyur.parekh@roivant.com Media Stephanie Lee stephanie.lee@roivant.com

Clinical ResultPhase 2Phase 3NDAPriority Review

28 Mar 2026

·www.globenewswire.com

New England Journal of Medicine Publishes Positive Phase 3 VALOR Trial Results of Brepocitinib in Dermatomyositis

The results of the Phase 3 VALOR trial were published in the New England Journal of Medicine, underscoring the practice-changing potential of brepocitinib 30 mg once-daily in dermatomyositis Brepocitinib 30 mg was superior to placebo on the primary and all nine key secondary endpoints, with statistically significant and clinically meaningful improvements observed across measures of global disease activity, muscle strength, skin disease, physical function, and corticosteroid reduction Additional analyses from VALOR, presented at the 2026 American Academy of Dermatology (AAD) Meeting, demonstrated meaningful improvements in itch and skin-related quality of life with brepocitinib 30 mg The U.S. Food and Drug Administration has granted Priority Review to brepocitinib’s New Drug Application (NDA) and assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of 2026 DURHAM, N.C., March 28, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics, a clinical-stage biotechnology company focused on developing targeted therapeutics in autoimmune disease, announced today the publication of results from the Phase 3 VALOR trial evaluating brepocitinib in adults with dermatomyositis (DM) in the New England Journal of Medicine (NEJM). As reported in the NEJM publication, “A Phase 3 Trial of Brepocitinib in Dermatomyositis,” VALOR enrolled 241 patients across 90 sites globally and met its primary endpoint, with brepocitinib 30 mg achieving a 15.3-point greater improvement in mean Total Improvement Score (TIS) at Week 52 compared to placebo (P<0.001). This clinical improvement was observed alongside meaningful corticosteroid tapering in the brepocitinib treatment arms, with nearly twice as many patients reducing background corticosteroids in the brepocitinib 30 mg group compared to placebo. Brepocitinib 30 mg also demonstrated statistically significant and clinically meaningful improvements on all nine key secondary endpoints, with treatment effects evident as early as Week 4 and sustained through Week 52. VALOR enrolled a broad, representative DM population that included patients with prior history of benign or malignant neoplasm and patients with multiple cardiovascular risk factors at baseline. Serious infections in the study were increased in brepocitinib 30 mg compared to placebo; these events resolved with medical management, and brepocitinib treatment was completed in most cases. Adverse events leading to treatment discontinuation occurred more frequently with placebo, as did malignancies, cardiovascular events, and thromboembolic events. The NEJM authors hypothesize in the publication that the elevated rates of these events in the placebo group reflect the baseline risks associated with dermatomyositis itself and the immunosuppressive agents — particularly systemic steroids — commonly used in its treatment. They also note the importance of the potential dual benefit of brepocitinib seen in the trial’s efficacy data – namely, reducing disease activity while simultaneously enabling substantial reductions in systemic corticosteroid exposure. “I anticipate that the VALOR trial results, which my collaborators and I were fortunate to publish in the New England Journal of Medicine, will be practice-changing for patients with dermatomyositis,” said Dr. Ruth Ann Vleugels, M.D., M.P.H., M.B.A., Heidi and Scott C. Schuster Distinguished Chair in Dermatology, Founding Director of the Autoimmune Skin Disease Center, Connective Tissue Disease Clinics, and Dermatology-Rheumatology Fellowship at Mass General Brigham, and Professor at Harvard Medical School. “These findings underscore the need to move beyond the historical paradigm of suboptimal disease control and reliance on systemic corticosteroids toward a patient-centric model focused on rapid, sustained, steroid-sparing efficacy with a modern, targeted therapy. Pending FDA approval, brepocitinib represents a monumental step forward in this direction, demonstrating impressive efficacy over 52 weeks across multiple measures of disease activity while also enabling meaningful corticosteroid reduction.” The full publication entitled, “A Phase 3 Trial of Brepocitinib in Dermatomyositis,” appears in the New England Journal of Medicine. Additional Skin-Focused Analyses Presented at the 2026 Annual American Academy of Dermatology (AAD) Meeting Additional analyses presented during the late-breaking abstract session at AAD 2026 provide deeper insight into the skin-specific and patient-reported benefits of brepocitinib beyond those reported in NEJM. These data demonstrate rapid and statistically significant reductions in itch, with an 18.9% greater proportion of patients achieving itch remission (PP-NRS ≤1) at Week 4 with brepocitinib 30 mg compared to placebo (95% CI: 5.0 to 32.9). Parallel improvements were observed in patient-reported, skin-related QoL (Skindex-16), with benefits sustained throughout the 52-week trial. Notably, among the 64% of patients with moderate-to-severe skin disease at baseline (a population often refractory to standard therapies), brepocitinib 30 mg was also associated with a 26.6% higher rate of functional skin remission compared to placebo (95% CI: 7.6 to 45.5; P=0.0060). About the Phase 3 VALOR Study The VALOR study was a global Phase 3 trial that enrolled 241 subjects with dermatomyositis across 90 sites. Subjects were randomized 1:1:1 to brepocitinib 30 mg, brepocitinib 15 mg, and placebo. Brepocitinib 30 mg demonstrated statistically significant and clinically meaningful improvement compared to placebo on the primary endpoint of Total Improvement Score (TIS) at Week 52. TIS is a composite endpoint of six core set measures of myositis disease activity. Benefit compared to placebo was seen as early as Week 4 and sustained at every visit thereafter through the end of the one-year double-blind treatment period. Brepocitinib 30 mg also demonstrated statistically significant and clinically meaningful improvement compared to placebo on all nine key secondary endpoints evaluated, including measures of muscle strength, skin disease activity, functional disability, and steroid tapering. More than two thirds of brepocitinib 30 mg patients achieved a Total Improvement Score of at least 40 (TIS40), twice the minimum clinically important difference. More than half achieved this TIS40 threshold while also reducing systemic corticosteroid use to ≤2.5 mg/day (prednisone-equivalent). The VALOR trial enrolled a broad, representative DM population including patients with prior history of benign or malignant neoplasm and patients with multiple cardiovascular risk factors. Serious infections in the study were increased in brepocitinib 30 mg compared to placebo; these events resolved with medical management, and brepocitinib treatment was completed in most cases. New or recurrent malignancy, cardiovascular events, and thromboembolic events in the study occurred more frequently in the placebo arm than the brepocitinib 30 mg arm. The brepocitinib safety database across all studies includes over 2,000 patients and subjects and suggests a safety profile similar to approved JAK and TYK2 inhibitors. The U.S. FDA has granted Priority Review to brepocitinib’s New Drug Application (NDA) and assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of 2026. About Priovant Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a first-in-class, selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis. The New Drug Application for brepocitinib in dermatomyositis is under review at FDA. Brepocitinib is also being evaluated in a Phase 3 program in non-infectious uveitis and recently generated positive Phase 2 data in cutaneous sarcoidosis, with a Phase 3 study to begin in calendar year 2026. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.com. Contact: Stephanie Lee, stephanie.lee@priovant.com

Clinical ResultPhase 3Priority ReviewNDA

03 Mar 2026

·investor.arbutusbio.com

Genevant Sciences and Arbutus Biopharma Announce $2.25 Billion Global Settlement With Moderna

Moderna to pay Genevant and Arbutus $950 million upfront and an additional $1.3 billion contingent upon a favorable resolution of Moderna’s Section 1498 appeal If the $1.3 billion payment is realized, this settlement will be the largest disclosed patent settlement paid in the pharmaceutical industry and the second largest in any industry Settlement holds Moderna accountable for infringement and provides for the court to enter judgment of no invalidity on the four Genevant/Arbutus patents asserted in the case Genevant grants Moderna a global non-exclusive license to its LNP delivery technology for SM-102-containing mRNA vaccines for infectious disease and a covenant not to sue for certain Genevant/Arbutus patents and Moderna products, ending all patent-infringement litigation against Moderna arising from its unauthorized use of the technology in its COVID-19 vaccines Pfizer/BioNTech litigation is ongoing in the United States following a favorable Markman ruling issued in September 2025; Comirnaty sales represent ~2/3 of global COVID-mRNA vaccine sales to date Arbutus announces that it is currently evaluating a return of capital to shareholders for the third quarter of calendar year 2026, in conjunction with the upfront payment Roivant will host an investor call to discuss these updates today, March 3, 2026, at 4:45 p.m. ET BASEL, Switzerland and VANCOUVER, British Columbia, March 03, 2026 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio and a subsidiary of Roivant Sciences Ltd. (Nasdaq: ROIV), and Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that they have entered into a $2.25 billion global settlement with Moderna, Inc. to resolve all U.S. and international enforcement actions involving Moderna’s unauthorized use of Genevant’s and Arbutus’ LNP delivery technology in its COVID-19 vaccines, including Spikevax®. As part of the settlement, Moderna will pay Genevant and Arbutus $950 million upfront in July 2026 and an additional $1.3 billion contingent upon an appellate ruling that 28 U.S.C. § 1498 (Section 1498) does not bar Genevant’s and Arbutus’ claims against Moderna for patent infringement, except as to doses characterized by the district court as having gone to U.S. government employees. In asserting that defense, Moderna argued that Section 1498 applies such that U.S. taxpayers should assume liability for its infringement of Genevant’s and Arbutus’ patents for sales made under one of its government contracts. Moderna has also consented to entry of a judgment of infringement and of no invalidity of four Genevant/Arbutus patents. Additionally, as a part of this settlement, Genevant has agreed to grant Moderna a global non-exclusive license to LNP delivery technology for infectious disease applications and a covenant not to sue for certain Genevant/Arbutus patents and Moderna products. For more information about the terms and conditions of the settlement with Moderna, including the contingent payment, please refer to Arbutus’ Current Report on Form 8-K filed with the SEC on March 3, 2026. “We are pleased with this settlement, which allows us to put this lengthy dispute behind us and remain focused on our mission to leverage our world-class nucleic acid delivery systems to bring innovative medicines to people who need them,” said James Heyes, CEO of Genevant Sciences. “At the same time, it is enormously gratifying for the Genevant team to, at long last, be recognized for our pivotal contribution to restoring normalcy around the world in the face of a once-in-a-lifetime pandemic.” “Nobel laureates, industry executives, and prominent researchers have long recognized that Arbutus scientists changed the drug development landscape when they invented LNP delivery technology, enabling nucleic acids including mRNA to be used for medicines and opening a new world of possibilities,” said Lindsay Androski, President and Chief Executive Officer of Arbutus. “Today, Moderna has finally acknowledged the same. This is a transformative outcome for Arbutus as a company, but more importantly, it is a long-overdue recognition that the COVID-19 vaccines would never have made it to the world without the seminal work of Ian MacLachlan, Ed Yaworski, Lloyd Jeffs, Kieu Lam, Lorne Palmer, and Cory Giesbrecht. Today, above all else, we celebrate – and in the case of Cory, remember – them.” Investor Conference Call Information Roivant will host a live conference call and webcast at 4:45 p.m. ET on Tuesday, March 3, 2026, to discuss Genevant’s and Arbutus’ $2.25 billion global settlement with Moderna. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About Genevant Sciences Genevant Sciences, a subsidiary of Roivant, is a leading nucleic acid delivery company with world-class platforms, a robust lipid nanoparticle (LNP) patent portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. Genevant’s scientists have pioneered LNP delivery of nucleic acids for over 20 years, and Genevant’s LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved systemic RNA-LNP product (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. For more information, please visit www.genevant.com. About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) and an oral PD-L1 inhibitor (AB-101) for the treatment of chronic hepatitis B (cHBV) infection. Arbutus is also consulting closely with and supporting its exclusive licensee, Genevant Sciences, to protect and defend its intellectual property, which is the subject of an on-going lawsuit against Pfizer/BioNTech for use of Arbutus’ patented LNP technology in their COVID-19 vaccines. For more information, visit www.arbutusbio.com. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.com. Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include, but are not limited to, statements about Arbutus’ plans with respect to ongoing patent litigation matters, including the expected timing thereof and the settlement of the Moderna litigation, and Arbutus’ evaluation of a potential return of capital to its shareholders. With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things, the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: uncertainties associated with litigation generally and patent litigation specifically; economic and market conditions may worsen; and risks related to the sufficiency of Arbutus’ cash resources for its foreseeable and unforeseeable operating expenses and capital expenditures. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.  Arbutus Biopharma Corporation ir@arbutusbio.com

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Indication	Highest Phase	Country/Location	Organization	Date
Erectile Dysfunction	Phase 2	Finland	Bayer AG	01 Aug 2010
Erectile Dysfunction	Phase 2	France	Bayer AG	01 Aug 2010
Erectile Dysfunction	Phase 2	Germany	Bayer AG	01 Aug 2010
Erectile Dysfunction	Phase 2	Italy	Bayer AG	01 Aug 2010
Erectile Dysfunction	Phase 2	Netherlands	Bayer AG	01 Aug 2010
Erectile Dysfunction	Phase 2	Spain	Bayer AG	01 Aug 2010
Erectile Dysfunction	Phase 2	Sweden	Bayer AG	01 Aug 2010
Cardiovascular Diseases	Phase 1	Germany	Bayer AG	06 Sep 2022
Chronic heart failure	Phase 1	Germany	Bayer AG	01 Oct 2007
Hypertension, Pulmonary	Phase 1	Germany	Bayer AG	01 Oct 2007

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