Roivant Sciences Ltd., a clinical-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of medicines and technologies.
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; an...
Roivant Sciences Ltd., a clinical-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of medicines and technologies.
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. the company advances its pipeline by creating nimble subsidiaries or ‘Vants’ to develop and commercialize the company’s medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.
Key Business Highlights for the fiscal year ended March 31, 2025, included:
Roivant
Announced the completion of the sale of Dermavant to Organon in October 2024.
Brepocitinib
Reported positive results in the Phase 2 NEPTUNE study of once-daily oral brepocitinib in non-infectious uveitis (‘NIU’). Brepocitinib demonstrated potential best-in-indication results on median time to treatment failure, the registrational endpoint, showing greater than 12 months for the 45 mg dose arm and 9.3 months for the 15 mg dose arm.
Initiated a Phase 3 program in NIU; topline data expected in the first half of calendar year 2027.
Initiated a Phase 2 study in cutaneous sarcoidosis (‘CS’) as the third indication for brepocitinib; topline data expected in the second half of calendar year 2026.
Completed enrollment of ongoing Phase 3 study in dermatomyositis; topline data expected in the second half of calendar year 2025.
Anti-FcRn Franchise
Reported top-line results of the company’s Phase 3 study of batoclimab in myasthenia gravis (‘MG’), which met its primary endpoint of change in MG-ADL from baseline in AChR+ patients. The 680 mg weekly by SC injection dose set a new benchmark for magnitude of benefit with a 5.6 point mean improvement and 93% MG-ADL Response Rate. Batoclimab demonstrated strong durability of Minimal Symptom Expression (MG-ADL = 0 or 1) (‘MSE’) with 75% of patients who achieved MSE on 680 mg dose by week 6 maintaining MSE status for =6 weeks. On the same day, the company also announced the initial results from period 1 of the Phase 2b study of batoclimab in chronic inflammatory demyelinating polyneuropathy (‘CIDP’) following standard of care washout, which demonstrated a mean improvement in the adjusted INCAT disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70%. In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints. Batoclimab was well tolerated with no new safety signals identified.
Reported additional positive results from the Phase 2a trial of batoclimab in Graves’ disease. Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly by SC injection followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77% leading to a 76% Response Rate (defined as T3 and T4 falling below the upper limit of normal without increasing the antithyroid drug (‘ATD’) dose). In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-Free Response. During Weeks 13 to 24, the lower 340 mg dose of batoclimab resulted in a mean IgG reduction of 65% (vs. 77% on 680mg dose) with a correspondingly lower responder rate of 68%. In addition, a lower ATD-Free Response Rate of 36% was also observed in the second 12 weeks. Patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher ATD-Free Response Rate than those who did not (60% vs. 23%). Batoclimab was well tolerated with no new safety signals identified.
Six total INDs cleared for IMVT-1402, with studies initiated in five indications: potentially registrational trials in Graves’ disease (‘GD’), difficult-to-treat rheumatoid arthritis, MG and CIDP, and a proof-of-concept trial in cutaneous lupus erythematosus. Results from Phase 3 trials of batoclimab in thyroid eye disease are expected in the second half of calendar year 2025.
Mosliciguat
Announced new pipeline program mosliciguat, a potential first-in-class and best-in-category inhaled soluble guanylate cyclase (‘sGC’) activator with targeted delivery to the lungs and once-daily administration. Inhaled mosliciguat is initially being developed for the treatment of pulmonary hypertension associated with interstitial lung disease (‘PH-ILD’), with potential to expand to other cardiopulmonary indications, including additional pulmonary hypertension groups.
In the Phase 1b ATMOS study (N=38) of mosliciguat following single dose inhaled administration in pulmonary hypertension (‘PH’) patients, clinically meaningful mean-max reductions in pulmonary vascular resistance (‘PVR’) of up to approximately 38% were observed and were sustained over the study period. These reductions represent some of the highest reductions seen in PH trials to date.
Initiated Phase 2 ‘PHocus’ study of mosliciguat in approximately 120 patients with PH-ILD; topline data expected in the second half of calendar year 2026.
Patent Infringement Litigation
Continued to progress patent infringement litigation against Moderna and Pfizer/BioNTech in the United States.
Initiated five patent infringement enforcement actions against Moderna outside of the United States, targeting alleged infringing activities in 30 countries.
Markman hearing held in the Pfizer/BioNTech case in December 2024, with ruling potentially to come in calendar year 2025.
Priovant
Priovant is developing brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1, for the treatment of dermatomyositis (‘DM’), non-infectious uveitis (‘NIU’), cutaneous sarcoidosis (‘CS’) and other immune-mediated diseases.
Brepocitinib is a potentially first-in-class, orally administered, small molecule inhibitor of TYK2 and JAK1 that suppresses signaling of TYK2- and JAK1-dependent cytokines linked to autoimmune disease, including type I and type II interferon, IL-6, IL-12 and IL-23.
Clinical data
Brepocitinib has been evaluated in seven positive completed Phase 2 studies in immune-mediated diseases (alopecia areata, psoriatic arthritis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, Crohn’s disease and non-infectious uveitis). In the six placebo-controlled studies, treatment with brepocitinib was associated with statistically significant and clinically meaningful efficacy. In the Phase 2 NEPTUNE proof-of-concept study, brepocitinib demonstrated the best time to treatment failure observed to date among active NIU studies measuring this registrational endpoint.
Brepocitinib’s safety database includes over 1,500 exposed participants evaluated in completed and ongoing clinical studies. In these studies, brepocitinib was generally safe and well tolerated, and rates of JAK class treatment-emergent adverse events (‘TEAEs’) of interest were comparable to those observed in the development programs of approved JAK inhibitors. Collectively, these data suggest a safety profile that is similar to those of approved JAK inhibitors.
In the Phase 2 NEPTUNE study of once-daily oral brepocitinib in NIU, the 45 mg results represented the best Treatment Failure rates observed to date among active NIU studies measuring this endpoint. On the pre-specified primary efficacy endpoint of Treatment Failure at week 24, a composite endpoint comprising multiple measures of ocular inflammation and visual acuity, as well as discontinuation due to intercurrent events or initiation of rescue therapy, 29% of subjects receiving brepocitinib 45 mg and 44% of subjects receiving brepocitinib 15 mg met Treatment Failure criteria (lower failure rates reflect greater treatment benefit). The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the brepocitinib 45 mg arm. All secondary efficacy endpoints were also positive and dose responsive, including measurements of potential benefit on prevention and treatment of uveitic macular edema. 52-Week data from the same study confirmed sustained treatment effect and tolerability. Brepocitinib was generally safe and well tolerated in the study, with no new safety and tolerability signals identified.
Brepocitinib has not been evaluated in DM to date. However, several FDA-approved JAK inhibitors have been clinically validated in DM patients refractory to standard-of-care therapies, as reported in more than 600 off-label case reports and in several open-label clinical trials. In addition, since DM pathobiology is driven by dysregulations in cytokines whose signaling is mediated by both TYK2 and JAK1, with its unique dual inhibition of both TYK2 and JAK1, brepocitinib, as compared to inhibitors selective to either TYK2 or JAK1, has the potential to demonstrate superior clinical efficacy in DM.
Development Plan and Upcoming Milestones
Priovant has completed enrollment for a large randomized, controlled Phase 3 study of brepocitinib in patients with refractory dermatomyositis.
Priovant has initiated a Phase 3 program in non-infectious uveitis; topline data are expected in the first half of calendar year 2027.
Priovant has initiated a Phase 2 study in cutaneous sarcoidosis; topline data are expected in the second half of calendar year 2026.
As of March 31, 2025, the company owned 75% of Priovant (or 67% on a fully diluted basis).
Immunovant
Immunovant is developing IMVT-1402, a potentially best-in-class inhibitor of the neonatal fragment crystallizable receptor (‘FcRn’), for the treatment of IgG-mediated autoimmune diseases, including Graves’ disease (‘GD’), difficult-to-treat rheumatoid arthritis (‘D2T RA’), Sjogren’s disease (‘SjD’), myasthenia gravis (‘MG’), chronic inflammatory demyelinating polyneuropathy (‘CIDP’) and cutaneous lupus erythematosus (‘CLE’).
Lead program
IMVT-1402 is a fully human monoclonal antibody that inhibits FcRn and has shown deep, dose-dependent IgG reductions in a Phase 1 clinical trial in healthy adults. The company expects to be able to reach approximately 80% IgG reductions with continued weekly dosing of 600 mg of IMVT-1402, offering deeper IgG reductions than observed with other competitor anti-FcRn programs. There has been consistent evidence observed across the class in over eight indications in Phase 2 and 3 trials with FcRn inhibitors that deeper IgG reductions correlate with meaningful improvements in clinical outcomes, further validated by data generated with the company’s first-generation anti-FcRn, batoclimab, in its own Phase 2 and 3 studies. IMVT-1402 offers a potentially best-in-class profile, with potentially best-in-class efficacy given its potential to achieve best-in-class IgG reductions, a favorable route of administration with a simple subcutaneous auto-injector, and potentially favorable safety profile.
IMVT-1402 is being developed in several indications representing potential first-in-class and best-in-class opportunities, including GD, D2T RA and CLE, and the company plans to leverage the potentially best-in-class profile of IMVT-1402 in indications where the anti-FcRn mechanism already has established a commercial presence, such as MG and CID.
Clinical Data
In September and November 2023, the company announced results from a Phase 1 clinical trial in healthy adults dosed with IMVT-1402. In the study’s 300 mg multiple-ascending dose (‘MAD’) cohort, a statistically significant reduction of 63% from baseline in mean total IgG levels was observed after four weekly 300 mg subcutaneous doses of IMVT-1402. In the 600 mg MAD cohort, the company observed a statistically significant reduction of 74% from baseline in mean total IgG levels after four weekly 600 mg subcutaneous doses of IMVT-1402. No or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels were observed in healthy adults administered IMVT-1402 in either dose cohort; the changes in albumin and LDL cholesterol were similar to those observed with placebo administration. Across all doses evaluated, treatment with IMVT-1402 was generally well tolerated, with only mild or moderate treatment-emergent adverse events observed.
In September 2024, the company reported additional positive results from the Phase 2a trial of batoclimab in Graves’ disease. Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly by SC injection followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77% leading to a 76% Response Rate. In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-Free Response. During Weeks 13 to 24, the lower 340 mg dose of batoclimab resulted in mean IgG reduction of 65% (vs. 77% on 680mg dose) with a correspondingly lower responder rate of 68%. In addition, a lower ATD-Free Response Rate of 36% was also observed in the second 12 weeks. Patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher ATD-Free Response Rate than those who did not (60% vs. 23%). Batoclimab was well tolerated with no new safety signals identified.
In March 2025, the company announced top-line results of its Phase 3 study of batoclimab in MG, which met its primary endpoint of change in the Myasthenia Gravis Activities of Daily Living (‘MG-ADL’) score from baseline in acetylcholine receptor antibody positive (‘AChR+’) patients. The 680 mg weekly by SC injection dose set a new benchmark for magnitude of benefit with a 5.6 point mean improvement in MG-ADL and a 93% Response Rate (defined as a = 2-point reduction in MG-ADL from baseline). Batoclimab demonstrated strong durability of Minimal Symptom Expression (MG-ADL = 0 or 1) (‘MSE’) with 75% of patients who achieved MSE on 680 mg dose by week 6 maintaining MSE status for = 6 weeks. On the same day, the company also announced the initial results from period 1 of the Phase 2b study of batoclimab in CIDP following standard of care washout, which demonstrated a mean improvement in the adjusted inflammatory neuropathy cause and treatment (‘aINCAT’) disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70%. In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints. Batoclimab was well tolerated with no new safety signals identified.
In April 2025, the company presented observations from a proof-of-principle case study evaluating IMVT-1402 in an SCLE patient over a period of 12 weeks. The participant in the case study had a baseline Cutaneous Lupus Erythematosus Disease area and Severity Index activity (‘CLASI-A’) score at screening of 36, which falls into the severe range of the clinical scale. The participant received open-label weekly treatment with 600 mg of IMVT-1402 for 12 weeks and saw significant clinical improvement in both skin lesions and alopecia. By week 12, the participant had a greater than 60% reduction in CLASI-A score to 13. A 5-point reduction in CLASI-A is considered clinically meaningful and this participant improved by 23 points by week 12. The participant also achieved approximately 78% total IgG reduction from baseline by week 12. A second patient dosed in this study also showed significant clinical improvement, with a CLASI-A score of 18 at screening reduced to 8 by week 12 of QW dosing, a >50% improvement.
As of March 31, 2025, the company owned 57% of Immunovant (or 52% on a fully diluted basis).
Pulmovant
Pulmovant is developing mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (‘PH-ILD’) and potentially other cardiopulmonary diseases.
Mosliciguat is a potentially first-in-class and potentially best-in-category once daily, inhaled sGC activator. Mosliciguat is being developed in PH-ILD, which is a large, well-validated market with only two approved treatments (both inhaled treprostnil), which are limited to the U.S. and a small number of other countries. In a dose escalation, proof-of-concept Phase 1b trial that assessed the efficacy, safety, tolerability, and pharmacokinetics of mosliciguat following single dose inhaled administration in pulmonary hypertension (‘PH’) patients, clinically meaningful mean-max reductions in pulmonary vascular resistance (‘PVR’) of up to approximately 38% were observed and were sustained over the study period. These reductions represent some of the highest reductions seen in PH trials as of March 31, 2025.
Clinical Data
Phase 1b data from the non-randomized, open-label ATMOS study with a single inhaled dose of mosliciguat showed dose-dependent mean-max reductions in PVR of up to 38% in Group 1 (PAH) and Group 4 (CTEPH) PH patients and demonstrated a favorable safety profile with no clinically relevant systemic side effects, such as heart rate and blood pressure changes. Trials of other agents in PAH have shown that reductions in PVR are potential predictors of success on clinical outcomes such as 6-minute walk distance.
Development Plan and Upcoming Milestones
The company has initiated and are actively enrolling a global Phase 2 trial to evaluate the safety and efficacy of mosliciguat in PH-ILD, with data expected in the second half of calendar year 2026. As of March 31, 2025, the company owned 100% of Pulmovant (or 92% on a fully diluted basis).
Genevant
Genevant is a technology-focused nucleic acid delivery and development company with two delivery platforms—a lipid nanoparticle (‘LNP’) platform and a ligand conjugate platform—an expansive intellectual property portfolio and deep scientific expertise, focused on partnering with other pharmaceutical or biotechnology companies to enable the development of nucleic acid therapeutics for unmet medical needs.
Delivery Platforms and Patent Portfolio
Genevant has two delivery platforms: LNP and ligand conjugate.
LNP platform
Technology used in the first systemic RNA-LNP product to receive FDA-approval, Alnylam’s Onpattro (patisiran) for the treatment of polyneuropathy caused by hereditary ATTR amyloidosis.
Outperformed all third-party formulations tested in a head-to-head in vivo ionizable lipid study assessing LNP potency and immune stimulation.
Clinically validated for hepatocyte and vaccine applications and in various stages of development for other traditionally hard-to-reach tissues and cell types, including T-cells, immune cells, stellate cells, lung, eye, and central nervous system.
More than 550 issued patents and pending patent applications worldwide as of March 31, 2025, including patents directed to lipid structures, including cationic and PEG-lipids; particle compositions, including ranges of lipid ratios for nucleic acid-containing particles; nucleic acid-containing particles with certain structural characteristics; mRNA-containing LNP formulations; and various manufacturing process aspects.
Ligand Conjugate Platform
Novel GalNAc ligands with clinical validation from imdusiran, an siRNA in Phase 2 clinical development by Arbutus Biopharma for the treatment of chronic hepatitis B (cHBV).
In preclinical head-to-head testing, Genevant’s GalNAc ligands demonstrated equal or better preclinical potency, assessed by duration and magnitude of knockdown, compared to an industry benchmark.
Applying delivery expertise to design novel extrahepatic ligands to expand therapeutic reach.
Collaboration-Based Business Model
Genevant seeks to partner with other pharmaceutical or biotechnology companies in the development of RNA therapeutics, crafting mutually beneficial collaborations that allow collaboration partners to access its innovative technologies while providing Genevant the opportunity to leverage its expertise to expand the technology and its therapeutic application.
Genevant uses its expertise in the delivery of nucleic acid therapeutics to develop optimal delivery systems for its collaborators’ identified payloads.
Genevant’s collaboration-based business model is to seek upfront payments, R&D reimbursements, milestones and royalties or profit sharing upon success, while also retaining certain rights in the delivery-related intellectual property developed in the context of the collaboration for potential use or out-licensing.
Some collaboration partners include Novo Nordisk, BioNTech, Takeda, Korro Bio, Repair Biotechnologies, Editas Medicine, Epitopea and Mammoth Biotechnologies.
Clinical and Preclinical Data
Genevant LNP technology has been in clinical trials of over a dozen distinct product candidates, representing hundreds of subjects of clinical experience.
In a head-to-head study in mice comparing multiple LNP formulations which varied only the key ionizable lipid, Genevant’s formulation outperformed all third-party formulations tested. Genevant’s formulation showed superior potency and tolerability (based on an assessment of immune stimulation) relative to others.
Genevant LNP technology is included in the first systemic RNA-LNP product to receive FDA-approval, Alnylam’s Onpattro (patisiran) for the treatment of polyneuropathy caused by hereditary ATTR amyloidosis.
As of March 31, 2025, the company owned 83% of Genevant (or 64% on a fully diluted basis).
Vant License Agreements & Other Vant Agreements
Priovant
License and Collaboration Agreement with Pfizer, Inc.
In September 2021, the company’s subsidiary Priovant Therapeutics, Inc. (‘Priovant’) entered into a license and collaboration agreement with Pfizer (the ‘Pfizer-Priovant License Agreement’). Pursuant to the Pfizer-Priovant License Agreement, Pfizer granted Priovant an exclusive, worldwide, sublicensable, royalty-bearing license under certain patents, and a non-exclusive, worldwide, sublicensable, royalty-bearing license under certain know-how, in each case, to develop, manufacture and commercialize brepocitinib and TYK2 compounds and products incorporating such compounds for all human and animal uses.
Immunovant
License Agreement with HanAll Biopharma Co., Ltd.
In December 2017, the company’s wholly owned subsidiary, Roivant Sciences GmbH (‘RSG’), entered into a license agreement with HanAll Biopharma Co., Ltd. (‘HanAll’) (the ‘HanAll Agreement’). Under the HanAll Agreement, RSG received the non-exclusive right to manufacture and the exclusive, royalty-bearing right to develop, import and use the antibody referred to as batoclimab, certain back-up and next-generation antibodies (including IMVT-1402), and products containing such antibodies, and to commercialize such products, in the U.S., Canada, Mexico, the E.U., the U.K., Switzerland, the Middle East, North Africa and Latin America (the ‘HanAll Licensed Territory’), for all human and animal uses during the term of the agreement. With respect to these licenses, RSG also received the right to grant a sublicense, with prior written notice to HanAll of such sublicense, to a third party in any country in the HanAll Licensed Territory outside of the U.S. and E.U.; an affiliate of RSG in any country in the HanAll Licensed Territory; and a third party in the U.S. and E.U. only after submission of a biologics license application (‘BLA’) in the U.S. or a Marketing Authorization Application in the E.U. Pursuant to the HanAll Agreement, RSG granted to HanAll an exclusive, royalty-free license under certain RSG patents, know-how and other intellectual property controlled by RSG relating to such antibodies and products to develop, manufacture and commercialize such antibodies and products for use outside of the HanAll Licensed Territory. HanAll also reserves the right to conduct discovery or research activities with the batoclimab antibody, and certain back-up and next-generation antibodies (including IMVT-1402), with or through a contract research organization or service provider in the HanAll Licensed Territory.
Product Service Agreement and Master Services Agreement
On November 17, 2021, ISG entered into a Product Service Agreement (‘PSA’) with Samsung Biologics Co., Ltd. (‘Samsung’), pursuant to which Samsung will manufacture and supply ISG with batoclimab drug substance for commercial sale, if approved, and perform other manufacturing-related services with respect to batoclimab. ISG previously entered in a Master Services Agreement (‘MSA’) with Samsung, dated April 30, 2021, which governs certain terms of its relationship with Samsung. In addition, ISG has a minimum obligation to purchase further batches of batoclimab in the four-year period of 2026 through 2029.
Pulmovant
License Agreement with Bayer
In July 2023, the company’s subsidiary Pulmovant, Inc. (‘Pulmovant’) entered into a license agreement (the ‘Bayer-Pulmovant License Agreement’) with Bayer Aktiengesellschaft (‘Bayer’). Pursuant to the Bayer-Pulmovant License Agreement, Bayer granted Pulmovant an exclusive, worldwide, sublicensable, royalty-bearing license under certain patents and know-how to use, develop, commercialize and manufacture mosliciguat compounds and products containing or comprising such compounds for the prevention, treatment, mitigation, cure and/or diagnosis of any disease in humans or animals.
Genevant
Cross-License Agreement with Arbutus Biopharma Corporation
In April 2018, the company’s subsidiary, Genevant Sciences Ltd. (together with its subsidiaries, ‘Genevant’), entered into a cross-license agreement with its affiliate, Arbutus Biopharma Corporation (‘Arbutus’) (as amended, the ‘Arbutus Cross-License Agreement’). Pursuant to the Arbutus Cross-License Agreement, Arbutus granted Genevant an exclusive, sublicensable, worldwide, transferable, irrevocable and perpetual license under certain patents and know-how relating to Arbutus’s lipid nanoparticle and GalNAc technologies for all applications other than hepatitis B virus, and certain other excluded fields. The license is subject to certain rights which had previously been licensed by Arbutus to third parties.
The patents and pending patent applications, if granted, licensed under the Arbutus Cross-License Agreement began to expire as early as 2023, and end as late as 2041, without giving effect to any potential patent term extensions or patent term adjustments.
Intellectual Property
Patents and Patent Applications
Priovant
As of March 31, 2025, Priovant Therapeutics, Inc. had exclusively licensed rights to six patent families for brepocitinib containing at least 176 issued patents and 62 pending patent applications in the U.S. and other jurisdictions, including the European Union and Japan, with claims covering a composition of matter, a crystalline form, a topical formulation, a process for making brepocitinib, a treatment of hidradenitis, a dosage regimen for the treatment of hidradenitis and treatment of dermatomyositis with brepocitinib. These patents and pending applications, if issued, are expected to expire as early as 2035, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and exclusively licensed rights to three patent families for ropsacitinib containing at least 138 issued patents and 31 pending patent applications in the U.S. and other jurisdictions, including the European Union and Japan, with claims covering a composition of matter, a treatment of hidradenitis and a crystalline form. These patents and pending applications, if issued, are expected to expire as early as 2037, in each case without considering any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
Anti-FcRn Franchise
ISG owns a registered trademark for IMMUNOVANT and a registered trademark for its corporate logo in conjunction with IMMUNOVANT.
Pulmovant
As of March 31, 2025, Pulmovan had exclusively licensed rights to five patent families for mosliciguat containing at least 84 issued patents and 70 pending patent applications in the U.S. and other jurisdictions, including the European Union and Japan, with claims covering the composition of matter, a crystalline form, a formulation for inhalation, a process for making mosliciguat, a treatment of cardiopulmonary disorders, including PH Group 3, and a dosage regimen for the treatment of cardiopulmonary disorders, including PH Group 3. These patents and pending applications, if issued, are expected to expire between 2033 and 2042, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
Genevant
As of March 31, 2025, Genevant Sciences GmbH (‘GSG’) owned or co-owned 24 patent families containing 41 issued patents and 122 pending patent applications in the U.S., European Union and numerous other jurisdictions, including claims relating to lipid nanoparticle delivery technology, polymers and nucleic acid delivery constructs. These patents and pending applications, if issued, are expected to expire between 2029 and 2045, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
As of March 31, 2025, GSG had licensed 28 patent families containing 463 issued patents and 108 pending patent applications in the U.S., European Union and numerous other jurisdictions, including claims relating to delivery systems. These patents and pending applications, if issued, are expected to expire between June 2025 and 2041, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
Government Regulation
In the U.S., the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (the ‘FDCA’) and its implementing regulations and biologics under the FDCA and the Public Health Service Act (the ‘PHSA’), and their implementing regulations.
The company relies, and expects to continue to rely, on third parties to produce clinical quantities of its product candidates in accordance with cGMP regulations. Claims which include items or services resulting from a violation of the federal Anti-Kickback Statute are false or fraudulent claims for purposes of the False Claims Act. The company’s future marketing and activities relating to federal, state and commercial reimbursement for its product candidates, following regulatory approval, and the sale and marketing of the company’s product candidates, are subject to scrutiny under this law.
The U.S. Foreign Corrupt Practices Act (FCPA) also obligates companies whose securities are listed in the U.S. to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
Research and Development
The company’s research and development expenses included $550.4 million for the year ended March 31, 2025.
History
Roivant Sciences Ltd. was founded in April 2014.
