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Pulmovant, a clinical-stage biotech and Roivant (NASDAQ:ROIV) company, on Tuesday shared topline data from its Phase 2 PHocus clinical trial evaluating mosliciguat for pulmonary hypertension associated with interstitial lung disease (PH-ILD).

PH-ILD occurs when scarring and inflammation in the lungs restrict blood flow through the pulmonary arteries, raising blood pressure within the lungs.

Presented at the European Respiratory Society International Congress 2026, the data highlight meaningful clinical progress in PH-ILD patients.

PHocus Trial Achieves Primary And Secondary TargetsAt Week 16, the study met its primary endpoint by demonstrating a statistically significant, placebo-adjusted pulmonary vascular resistance reduction of 56.3%, derived from a 51.3% drop in mosliciguat patients versus a 6.6% increase in placebo.

The company called it the highest ever reported PVR reduction in any randomized controlled PH trial.

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Mosliciguat also met its secondary endpoints, delivering a placebo-adjusted 35.2-meter improvement in six-minute walk distance alongside a 357.7 pg/mL drop in NT-proBNP, a key cardiac strain biomarker.

Exploratory Results Display Strengthened EfficacyA pre-specified exploratory analysis revealed expanding therapeutic effects through Week 24.

Placebo-adjusted walk distance improvements expanded to 52.7 meters, while NT-proBNP reductions reached 487.1 pg/mL, representing a 75.9% decline.

Mosliciguat was well tolerated, with cough incidence reaching just 12.1% in the treatment arm compared to 18.2% in placebo, successfully avoiding a common issue seen with inhaled prostacyclins.

Novel Mechanism Drives Phase 3 ProgramMosliciguat operates as a potential first-in-class, once-daily inhaled sGC activator that triggers sGC independently of nitric oxide or heme status.

The mechanism provides targeted pulmonary vasodilation with limited systemic side effects while potentially offering anti-fibrotic, anti-inflammatory, and anti-apoptotic benefits.

With up to 200,000 Group 3 PH-ILD patients living across the U.S. and Europe, Roivant has already initiated patient enrollment for its Phase 3 PHrontier trial.

ROIV Stock Price Activity: Roivant Sciences shares were up 17.69% at $41.11 during premarket trading on Tuesday, according to Benzinga Pro data.

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Photo by T. Schneider via Shutterstock

© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Roivant Sciences Ltd. (ROIV) Presents at Wells Fargo 21st Annual Healthcare Conference Transcript

PHocus met its primary endpoint, demonstrating a clinically meaningful and statistically significant placebo-adjusted reduction in pulmonary vascular resistance (PVR) of -56.3% (p<0.0001) at Week 16, the highest ever reported PVR reduction in any randomized controlled PH trialThe study also met its secondary endpoints at Week 16 with a +35.2-meter placebo-adjusted improvement in six-minute walk distance (6MWD, p=0.0027) and a -53.2% (357.7 pg/mL) placebo-adjusted reduction in N-terminal pro–B-type natriuretic peptide (NT-proBNP, p=0.0002), both clinically meaningful and statistically significant Pre-specificed exploratory Week 24 results showed continued placebo-adjusted improvements in 6MWD to +52.7m (nominal p<0.0001) and NT-proBNP to -75.9% (-487.1 pg/mL, nominal p<0.0001) Mosliciguat was observed to be well tolerated with a favorable safety profile, and compared with placebo, a lower proportion of patients experienced cough (12.1% mosliciguat vs. 18.2% placebo), a common tolerability challenge with inhaled prostacyclins Phase 3 PHrontier study of mosliciguat in patients with PH-ILD has been initiated, with enrollment underway Results being presented today at the European Respiratory Society (ERS) International Congress 2026 by Professor Marc HumbertRoivant to host investor conference call and webcast today at 8:00 a.m. ET WALTHAM, Mass., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Pulmovant, a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases, and a Roivant (Nasdaq: ROIV) company, today announced positive results from its Phase 2 PHocus clinical trial evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. The results will be presented today at the European Respiratory Society (ERS) International Congress 2026.

“PH-ILD remains one of the most challenging forms of pulmonary hypertension to treat, given the heterogeneity of the disease and the fact that existing therapies are approved in limited geographies and poorly tolerated in patients with underlying lung disease,” said Marc Humbert, MD, PhD, Professor of Respiratory Medicine at Université Paris-Saclay and Director of the French National Reference Center for Pulmonary Hypertension. “The PVR reduction observed in PHocus is remarkable and among the largest reported in a randomized controlled PH trial to date. The consistency of benefit across hemodynamic, functional, and cardiac biomarker endpoints makes these results even more impressive. Together, these results represent a clinically meaningful advancement in this field and highlight the potential of mosliciguat to address a longstanding gap in care for a patient population with high mortality and limited treatment options.”

The PHocus study met its primary endpoint, demonstrating a clinically meaningful and statistically significant placebo-adjusted reduction in PVR of -56.3% (-51.3% mosliciguat vs. +6.6% placebo, p<0.0001) at Week 16. The study also met its secondary endpoints on a placebo-adjusted basis, demonstrating a clinically meaningful and statistically significant improvement in 6MWD of +35.2 meters (+20.3 mosliciguat vs. -14.9 placebo, p=0.0027) and a clinically meaningful and statistically significant reduction in NT-proBNP, a biomarker of cardiac strain, of -357.7 pg/mL (p=0.0002), corresponding to a -53.2% reduction from baseline at Week 16.

In a pre-specified exploratory analysis, treatment effects continued to strengthen through the end of the placebo-controlled period. By Week 24, the placebo-adjusted improvement in 6MWD reached +52.7 meters (nominal p<0.0001), while NT-proBNP showed a placebo-adjusted reduction of -487.1 pg/mL (-75.9%; nominal p<0.0001).

Mosliciguat was observed to be well tolerated, with a favorable safety profile and adverse events consistent with the underlying PH-ILD condition. Notably, the incidence of cough, a common tolerability concern with inhaled prostacyclins, was lower than placebo in patients receiving mosliciguat (12.1% for patients receiving mosliciguat vs. 18.2% for patients receiving placebo).

Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action designed to deliver targeted pulmonary vasodilation with limited systemic side effects for the treatment of PH-ILD. Mosliciguat targets sGC, a key enzyme in the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling pathway that catalyzes cGMP production. Elevated cGMP levels are known to promote vasodilation and potentially contribute to anti-fibrotic effects, reduce inflammation and apoptosis, and reverse vascular remodeling. The PHocus results support mosliciguat's potential as an sGC activator, mechanistically distinct from sGC stimulators, to activate sGC independent of NO/heme status. This positions mosliciguat to address both oxidative-stress-associated diseases such as PH-ILD, where native sGC function is impaired, as well as diseases where native sGC remains responsive to NO/heme signaling.

PH is classified into five groups based on underlying causes, symptoms, and treatment approaches. Group 3 PH is a subtype of PH that arises from lung diseases, such as interstitial lung disease (ILD). ILD describes a large group of diseases that cause progressive damage to the lungs, making it difficult for patients to breathe. Up to 200,000 patients across the U.S. and Europe are living with PH-ILD, a subset of Group 3 PH, and have limited or no approved treatment options.

“Our robust Phase 2 PHocus study results, in conjunction with mosliciguat’s inhaled, once-a-day administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD. Today, the treatment landscape is sparse, primarily consisting of formulations of inhaled treprostinil and their associated limitations, and off-label use of PDE5 inhibitors. With these results, mosliciguat has demonstrated that it may address many of these treatment gaps,” said Drew Fromkin, Chief Executive Officer of Pulmovant. “We are truly grateful to the patients, investigators, and site teams who made this study possible. We are also pleased to announce that our Phase 3 PHrontier study for patients with PH-ILD has been initiated with the goal of rapidly bringing mosliciguat to patients battling PH-ILD.”

The initiation of the Phase 3 PHrontier clinical trial of mosliciguat in PH-ILD, in tandem with the completion of our PHocus study, reflects the company’s commitment to expedite mosliciguat’s development and, upon approval, access to patients who are in need of effective treatment options.

For more information on the PHrontier study, please visit PhrontierStudy.com.

About the PHocus Study

The Phase 2 PHocus clinical study (NCT06635850) is a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy of mosliciguat in adult patients with PH-ILD. The study enrolled 135 patients across 87 sites in 20 countries.

About the PHrontier Study

The Phase 3 PHrontier clinical study is a randomized (1:1), double-blind, placebo-controlled, global trial evaluating the safety and efficacy of mosliciguat in adult patients with PH-ILD. The study is currently designed to enroll approximately 375 patients worldwide.

About Pulmonary Hypertension and Interstitial Lung Disease

Pulmonary hypertension (PH) is a progressive and debilitating condition characterized by high blood pressure in the blood vessels of the lungs. This elevated pressure forces the heart to work harder to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, chest pain, and dizziness. The World Health Organization (WHO) has classified PH into five groups based on underlying causes, symptoms, and treatment approaches. Group 3 PH is a subtype of PH that arises from lung diseases, such as interstitial lung disease (ILD). ILD describes a large group of diseases that cause progressive damage to the lungs, making it difficult for patients to breathe. Up to 200,000 patients across the U.S. and Europe are living with PH-ILD, a subset of Group 3 PH, and have limited or no approved treatment options. For more information, please visit www.pulmovant.com/our-science.

About Mosliciguat

Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action, which may have broad application across the spectrum of pulmonary hypertension (PH). Mosliciguat targets sGC, a key enzyme in the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling pathway that catalyzes cGMP production. Elevated cGMP levels are known to promote vasodilation, contribute to anti-fibrotic effects, reduce inflammation and apoptosis and reverse vascular remodeling. Unlike sGC stimulators, which require reduced heme and NO to exert their effect, mosliciguat is an sGC activator that is believed to work independently of heme and NO. In the Phase 2 PHocus study, once-daily dosing of inhaled mosliciguat in PH patients was observed to be well tolerated and led to a reduction in pulmonary vascular resistance (PVR) of 56.3%, the highest ever reported PVR reduction in any randomized controlled PH trial. Mosliciguat also improved six-minute walk distance (6MWD) by 35.2 meters at Week 16 (secondary endpoint) and 52.7 meters at Week 24 (exploratory endpoint). Mosliciguat is currently being evaluated in the Phase 3 PHrontier study. For information on the Phase 3 PHrontier study of mosliciguat, please visit PhrontierStudy.com.

Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, September 8, 2026, to discuss the Phase 2 results for mosliciguat in PH-ILD and Phase 3 initiation. To access the conference call by phone, please register online using this registration link. The presentation and webcast details are available under “Events & Presentations” in the Investors section of the Roivant website at www.investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

About Pulmovant

Pulmovant is a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases and is a Roivant (Nasdaq: ROIV) company. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD. For more information, please visit www.pulmovant.com.

About Roivant

Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody 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. For more information, visit www.roivant.com.

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 and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. 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.

© 2026 Pulmovant, Inc. All Rights Reserved. All trademarks are the property of their respective owners.

Contact

[email protected]

 | Source: Pulmovant, Inc.

WALTHAM, Mass., Sept. 06, 2026 (GLOBE NEWSWIRE) -- Pulmovant, a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases, and a Roivant (Nasdaq: ROIV) company, today announced that results from the Phase 2 PHocus study of mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented at the European Respiratory Society (ERS) International Congress 2026 at 12:15 CEST (6:15 a.m. ET) on Tuesday, September 8, 2026, by Marc Humbert, MD, PhD, Professor of Respiratory Medicine at Université Paris-Saclay and Director of the French National Reference Center for Pulmonary Hypertension.

Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action designed to deliver targeted pulmonary vasodilation with limited systemic side effects for the treatment of PH-ILD.

The Phase 2 PHocus clinical study (NCT06635850) is a randomized, double-blind, placebo-controlled, global trial that enrolled 135 adult participants with PH-ILD to assess the safety and efficacy of mosliciguat. Mosliciguat is also being evaluated in the Phase 2 PHactor clinical study (NCT07333183), an open-label trial evaluating the tolerability and safety of inhaled mosliciguat in combination with inhaled treprostinil in participants with PH-ILD.

About Pulmonary Hypertension and Interstitial Lung Disease
Pulmonary hypertension (PH) is a progressive and debilitating condition characterized by high blood pressure in the blood vessels of the lungs. This elevated pressure forces the heart to work harder to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, chest pain, and dizziness. The World Health Organization (WHO) has classified PH into five groups based on their underlying causes, symptoms, and treatment approaches. Group 3 PH is a subtype of PH that arises from lung diseases, such as interstitial lung disease (ILD). ILD describes a large group of diseases that cause progressive damage to the lungs, making it difficult for patients to breathe. Up to 200,000 patients across the U.S. and Europe are living with PH-ILD, a subset of Group 3 PH, and have limited or no approved treatment options. For more information, please visit https://www.pulmovant.com/our-science.

About Mosliciguat
Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action, which may have broad application across the spectrum of pulmonary hypertension (PH). Mosliciguat targets sGC, a key enzyme in the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling pathway that catalyzes cGMP production. Elevated cGMP levels are known to promote vasodilation, contribute to anti-fibrotic effects, reduce inflammation and apoptosis and reverse vascular remodeling. Unlike sGC stimulators, which require reduced heme and NO to exert their effect, mosliciguat is an sGC activator that is believed to work independently of heme and NO.  In the Phase 1b ATMOS study of mosliciguat, a single dose of inhaled mosliciguat in PH patients was well tolerated and led to clinically meaningful, mean peak reduction in pulmonary vascular resistance (PVR) of up to 38%, one of the highest reductions seen in pulmonary hypertension trials to date. For information on the Phase 2 PHocus study of mosliciguat, please visit https://phocusstudy.com.

About Pulmovant
Pulmovant is a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases and is a Roivant (Nasdaq: ROIV) company. Pulmovant’ s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 2 PHocus global clinical trial in PH-ILD. For more information, please visit https://www.pulmovant.com.

About Roivant

Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody 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. For more information, visit www.roivant.com.

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 and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. 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.

© 2026 Pulmovant, Inc. All Rights Reserved. All trademarks are the property of their respective owners.

Contact
[email protected]

 | Source: Roivant Sciences

JAMA Dermatology publication includes results from VALOR skin-specific secondary endpoints, with rapid and durable improvements seen for brepocitinib 30 mg compared to placebo across multiple dimensions of cutaneous dermatomyositis (DM), including measurements of disease activity, itch, and skin-related quality of lifeIn patients with at least moderate itch at baseline, clinically meaningful improvements were observed as early as Week 4 in 54% of brepocitinib 30 mg patients versus 10% with placebo, increasing to 74% versus 33%, respectively, by Week 52Nearly half of brepocitinib 30 mg treated patients with moderate-to-severe skin disease at baseline achieved remission-level outcomes by Week 52, with 46% demonstrating “Clear” or “Almost Clear” skin on the Investigators Global Assessment (IGA) and 44% achieving functional skin remission on the Cutaneous Dermatomyositis Activity and Severity Index – Activity Score (CDASI-A), more than two-fold higher than with placebo (22% and 21%, respectively) Results complement the primary efficacy and safety results from the VALOR trial previously published in the New England Journal of Medicine and reinforce brepocitinib’s potential as an important treatment for signs and symptoms of skin disease in dermatomyositis, regardless of muscle involvement DURHAM, N.C., Aug. 26, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics announced today the publication in JAMA Dermatology of skin-specific outcomes from the Phase 3 VALOR trial evaluating brepocitinib, a first-in-class oral TYK2 and JAK1 inhibitor, in adults with dermatomyositis (DM). Primary efficacy and safety results from the trial were previously published in the New England Journal of Medicine, including benefit on measures of skin disease, muscle strength, physical function, and steroid-sparing.

“Skin disease is a major and often underappreciated driver of morbidity in dermatomyositis, with an impact on quality of life that exceeds most other inflammatory skin diseases,” said Victoria P. Werth, MD, Professor of Dermatology and Medicine at the Perelman School of Medicine at the University of Pennsylvania, Chief of the Division of Dermatology at the Philadelphia Veterans Administration Hospital, and one of the lead investigators of the Phase 3 VALOR Trial. “The rapid and sustained improvements in cutaneous disease activity and itch seen in the VALOR trial, together with the achievement of functional skin remission for many patients with moderate-to-severe skin disease at baseline, represent a monumental finding for patients with dermatomyositis. These results are particularly meaningful given how difficult cutaneous dermatomyositis manifestations and symptoms have historically been to control with conventional therapies.”

In the analyses published in JAMA Dermatology, brepocitinib 30 mg produced rapid, durable and clinically meaningful improvements across multiple dimensions of cutaneous dermatomyositis, including skin disease activity, itch and skin-related quality of life. Treatment effects were evident as early as Week 4 and sustained through Week 52, with significantly more brepocitinib-treated patients achieving clinically meaningful improvements in skin disease activity and itch, as well as remission-level skin outcomes, compared with placebo. The table below summarizes the results published in JAMA Dermatology:

 Brepocitinib 30 mgPlaceboDelta (95% CI)Disease Activity1Achievement of Clinically Meaningful CDASI-A Response (≥40% Improvement and ≥ 4-Point Improvement) at Week 5261.7%44.3%16.8% (1.1–32.5, P=0.04)Remission2Achievement of Gold Standard ≥ 2-category improvement on IGA to “Clear” / “Almost Clear” Skin at Week 5245.7%21.8%21.1% (2.5 to 39.7)Achievement of Functional Skin Remission (CDASI-A ≤ 5) at Week 5243.5%20.8%26.6% (7.6 to 45.5)Itch3Achievement of Clinically Meaningful Itch Reduction (≥ 2-point improvement in PP-NRS) by Week 454.0%9.5%47.3% (30.4 to 64.1)Achievement of Clinically Meaningful Itch Reduction (≥ 2-point Improvement in PP-NRS) by Week 5274.0%33.3%39.8% (18.9-60.6)Skin-Related QoL1Improvement in Skindex-164 by Week 412.90.911.9 (6.0 to 17.9) 1Among all participants
2Among participants with at least moderate skin disease at baseline
3Among participants with at least moderate itch at baseline
4Minimal clinically important difference defined as 10 units of improvement

Abbreviations: CDASI-A, Cutaneous Dermatomyositis Disease Area and Severity Index - Activity; CDA-IGA, Cutaneous Dermatomyositis Activity-Investigator’s Global Assessment; PP-NRS, Peak Pruritus-Numerical Rating Scale; Skindex-16, skin-related quality of life

Improvements in skin disease occurred alongside reductions in oral corticosteroid (OCS) use. Among patients receiving OCS at baseline, 61.7% of patients treated with brepocitinib 30 mg tapered to 2.5 mg/day (prednisone-equivalent) or less by Week 52 compared to 34.4% receiving placebo, while 41.7% discontinued OCS altogether compared with 23.4% receiving placebo. These findings support brepocitinib’s potential to deliver meaningful control of skin disease alongside substantial tapering of OCS, an important treatment goal in DM given the cumulative toxicity associated with systemic corticosteroid use.

As previously published in the New England Journal of Medicine, 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 supports a safety profile consistent with the known safety profile of JAK inhibitors.

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). Brepocitinib exhibited a safety profile consistent with the known safety profile of JAK inhibitors, with no new safety signals identified.

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 selective 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. Brepocitinib is also being evaluated in a Phase 3 program in non-infectious uveitis, a Phase 3 program in cutaneous sarcoidosis, and a Phase 2b/3 program in lichen planopilaris. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.

Contacts:

Stephanie Lee: [email protected] 

LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune diseaseLISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesisLISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conductedLISRAYA is available immediately in the U.S.Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 a.m. ET.

BASEL, Switzerland and LONDON and NEW YORK, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that the U.S. Food and Drug Administration (FDA) has approved LISRAYA™ (brepocitinib) 30 mg for the treatment of adults with dermatomyositis (DM). LISRAYA is a pill taken once daily.

DM is a rare systemic autoimmune disease characterized by progressive muscle weakness and extensive, painful, and pruritic skin lesions. DM significantly impairs patients’ quality of life through physical disability, pain from both muscle and skin disease, cutaneous disfigurement, skin sensitivity to light and touch, and high levels of dependency on chronic high-dose steroids.

"We are hopeful the approval of LISRAYA in DM will be the first of many for brepocitinib, and will provide an important new treatment option for these patients." said Matt Gline, CEO of Roivant. "I'm proud of the work our teams have put in to get here, and we remain focused on advancing our late-stage programs in non-infectious uveitis, cutaneous sarcoidosis, and lichen planopilaris — all also diseases where patients have been waiting a long time for better options.” 

LISRAYA, a first-in-class TYK2/JAK1 inhibitor, is the first and only targeted therapy approved for dermatomyositis. LISRAYA is proven to provide a wide array of efficacy benefits for adult DM patients, including improvements in skin disease, muscle strength, physical function, and overall disease burden, alongside substantial steroid-sparing benefit. LISRAYA can be prescribed by healthcare professionals in the United States effective immediately. Prescriptions can be submitted at lisrayahcp.com/enroll. Full prescribing information is available at lisrayahcp.com/pi.

“Dermatomyositis affects nearly every aspect of a patient’s life, causing physical disability, disfiguring skin disease, pain, itch, and a profound loss of independence and sense of self,” said Ruth Ann Vleugels, MD, MPH, MBA, Heidi and Scott C. Schuster Distinguished Chair in Dermatology, Founding Director of the Autoimmune Skin Disease Center and Connective Tissue Disease Clinics at Mass General Brigham, and Professor of Dermatology at Harvard Medical School.  “For many decades, the treatment of dermatomyositis has relied on chronic steroids, non-specific immunomodulators, and intravenous immunoglobulin—therapies not targeted to the underlying disease pathobiology. The approval of LISRAYA marks a turning point for patients living with dermatomyositis. For the first time, I am thrilled to be able to offer my patients a targeted, once-daily oral medicine that delivers meaningful benefit across muscle, skin, and overall disease activity while simultaneously reducing reliance on systemic corticosteroids.” 

LISRAYA’s approval follows the landmark Phase 3 VALOR trial, the largest DM trial ever conducted.

In the VALOR trial, benefits on the primary endpoint, the myositis Total Improvement Score (a composite measure designed to capture improvement across multiple disease domains), were seen as early as Week 4, increased over time, and were sustained to the end of the 52-week study. Most patients treated with LISRAYA were able to achieve both moderate or better improvement on the Total Improvement Score and minimal or no steroid use by the end of the study (55%, compared to 30% on placebo), underscoring LISRAYA’s ability to simultaneously improve disease symptoms and reduce steroid dependency. Among patients receiving LISRAYA who were taking ≥7.5 mg/day (prednisone-equivalent) of oral corticosteroids at baseline, 62% tapered to minimal or no steroid use (≤2.5 mg/day) by the end of the 52-week study, compared with 38% on placebo; 45% came off corticosteroids entirely, compared with 29% on placebo.

LISRAYA also demonstrated benefit on independent measures of skin disease and muscle strength, and, critically, on endpoints that directly capture patients’ own experience living with dermatomyositis. When asked to rate the overall activity of their disease, patients receiving LISRAYA reported more than four times as much improvement as patients on placebo. On a measure of everyday function – including pain and core activities of daily living such as getting dressed, climbing stairs, and running errands – patients treated with LISRAYA achieved clinically meaningful improvement, while those receiving placebo worsened, highlighting LISRAYA’s ability to restore greater independence and personal agency to DM patients’ lives.

The most common adverse reactions for patients on LISRAYA in the VALOR trial were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne. See important LISRAYA safety information below and full safety information, including boxed warning, at lisrayahcp.com/pi.

Primary results from the VALOR trial were published in the New England Journal of Medicine in March 2026, with additional skin-specific secondary endpoints published in JAMA Dermatology in August 2026.

LISRAYA is indicated for the treatment of dermatomyositis in adults. It can be used for adult DM patients with no restrictions based on their level of disease activity, clinical presentation, or prior treatment experience. LISRAYA can be used as an alternative therapy or add-on therapy to non-targeted DM treatments used today, depending on specific patient needs. Notably, the Phase 3 VALOR study evaluated the efficacy and safety of LISRAYA across patients on a wide array of different combinations of background therapies, including no background therapy.

Priovant is committed to helping patients access LISRAYA as quickly as possible. LISRAYA is available through a limited distribution network of specialty pharmacies. Patients can enroll in LISRAYA My Compass Support, which offers personalized assistance from a dedicated Patient Access Liaison, including help with insurance coverage, financial assistance programs, and ongoing support throughout the treatment journey. Through My Compass Support, eligible patients may pay as little as $0 per month for LISRAYA. Patients can enroll in My Compass Support at lisraya.com/enrollment.

“Today’s approval of LISRAYA marks a historic moment for the dermatomyositis community and reflects years of extraordinary work and sacrifice by the team at Priovant, our partners, and, above all, the investigators and patients who participated in the brepocitinib development program,” said Ben Zimmer, Chief Executive Officer of Priovant. “I am thrilled that adults with dermatomyositis finally have a fundamentally new treatment option – one specifically designed to target the biology of their disease and shown to meaningfully improve how patients feel and function in their daily lives.”    

FDA approval of LISRAYA follows the agency’s prior granting of Priority Review and Orphan Drug Designation. Priority Review is reserved for medicines that, if approved, would provide significant improvements in safety or efficacy for treatment of a serious condition.

LISRAYA IMPORTANT SAFETY INFORMATION and INDICATION AND USAGE

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE
CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

INDICATIONS AND USAGE
LISRAYA (brepocitinib) is indicated for the treatment of adults with dermatomyositis (DM).

Limitations of Use
Not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

WARNINGS and PRECAUTIONS:
Serious infections. Patients treated with LISRAYA are at increased risk of developing serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death.
Reported infections with use of Janus kinase (JAK) inhibitors, including LISRAYA:

Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Evaluate and test patients for latent and active TB infection prior to and during LISRAYA treatment. If positive, treat for TB. Monitor all patients for active TB during treatment including patients who tested negative for a latent TB infection prior to LISRAYA treatment.Invasive fungal infections. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens.
Avoid use of LISRAYA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of LISRAYA in patients with chronic or recurrent infection prior to initiating treatment. Closely monitor patients for signs and symptoms of infection during and after treatment with LISRAYA. If a serious infection occurs, interrupt LISRAYA treatment until the infection resolves or is adequately treated.

Mortality. A higher rate of all-cause mortality, including sudden cardiovascular death, was observed with another Janus kinase (JAK) inhibitor when compared to tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis (RA) 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA.

Malignancy. Malignancies have occurred in patients treated with LISRAYA. A higher rate of malignancies (excluding non-melanoma skin cancer), lymphomas, and lung cancers was observed with another JAK inhibitor when compared to TNF blockers in patients with RA. LISRAYA is not approved for use in patients with RA. Patients who are current or past smokers are at additional increased risk.

Major Adverse Cardiovascular Events (MACE). Major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) have occurred in patients treated with LISRAYA. A higher rate of MACE was observed with another JAK inhibitor when compared to TNF blockers in patients with RA 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA. Patients who are current or past smokers are at additional increased risk. Discontinue LISRAYA in patients who have experienced a myocardial infarction or stroke.

Thrombosis. Thromboses, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including LISRAYA. Many of these adverse reactions were serious and some resulted in death. A higher rate of thromboses was observed with another JAK inhibitor when compared to TNF blockers in patients with RA 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA. Avoid LISRAYA in patients who may be at risk of thrombosis. If symptoms of thrombosis occur, discontinue LISRAYA, promptly evaluate, and appropriately treat.

Hypersensitivity. LISRAYA is contraindicated in patients with known hypersensitivity to brepocitinib or any of its excipients. Hypersensitivity reactions were reported in patients receiving LISRAYA. Some events were serious.

Gastrointestinal Perforations. Gastrointestinal perforation has been reported in patients treated with JAK inhibitors, including LISRAYA. Monitor LISRAYA-treated patients who may be at risk for gastrointestinal perforation.

Hypoglycemia in Patients with Diabetes. LISRAYA may cause hypoglycemia in patients with diabetes. Hypoglycemia, including severe hypoglycemia, has been reported following initiation of JAK inhibitors in patients with diabetes. During treatment with LISRAYA, consider increased monitoring of blood glucose as clinically indicated in patients with diabetes.

Laboratory Abnormalities. LISRAYA has been associated with lab abnormalities including neutropenia, lymphopenia, anemia, increases in lipid parameters, and liver enzyme elevations.

Immunizations. Avoid use of live vaccines during or immediately prior to LISRAYA therapy initiation. Prior to initiating LISRAYA treatment, update immunizations, including prophylactic varicella zoster or herpes zoster vaccinations, according to current immunization guidelines.

Embryofetal Toxicity. Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to starting treatment. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LISRAYA and for 3 days following the last dose.

ADVERSE REACTIONS
The most common adverse reactions occurring in ≥5% of DM subjects and ≥2% greater than placebo were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne.

SPECIAL POPULATIONS
Pregnancy. Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Available data from LISRAYA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation. There are no data on the presence of brepocitinib in human milk, the effects on the breastfed infant, or the effects on milk production.

Hepatic Impairment. LISRAYA is not recommended in patients with severe hepatic impairment.

Renal Impairment. LISRAYA is not recommended in patients with severe renal impairment.

Please see the Full Prescribing Information, including BOXED WARNING, and Medication Guide.

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. ET on Friday, August 28, 2026, to report 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 https://investor.roivant.com/news-events/events. 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 LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody 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. For more information, visit www.roivant.com.

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 and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. 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 at [email protected]: Stephanie Lee at [email protected] dermatomyositis patients: 1-888-736-9788 or [email protected] © 2026 Priovant Therapeutics, Inc. All rights reserved. LISRAYA™ is the trademark of Priovant Therapeutics, Inc.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c822a26b-5df5-41c7-9018-13a195ea1f51

Roivant (ROIV.O) and partner Priovant Therapeutics on Friday set a list price of $35,000 for a ​30-day supply of their newly approved rare disease drug, ‌Lisraya.

Here are the details:

The daily pill, which launched immediately after FDA approval, is the first targeted oral treatment for dermatomyositis, a rare condition ​that causes painful skin rashes and progressive muscle weakness.

On ​an analyst call on Friday, Priovant CEO Ben Zimmer ⁠said prescribing is open and the first patient prescriptions ​have already come in.

The companies are offering a patient support ​program that can reduce out-of-pocket costs to $0 for eligible patients.

Roivant CEO Matt Gline estimated the net annual value to the company per patient on ​a full year of therapy to be in the ​low-to-mid $300,000 range, though he cautioned that market adoption is expected to build ‌gradually.

In ⁠the trial, patients receiving a daily 30 mg dose of Lisraya, chemically known as brepocitinib, achieved a mean total improvement score of 46.5 after 52 weeks, compared with 31.2 for ​placebo. The difference ​was statistically ⁠significant, with benefits seen as early as week four, the companies said.

Pfizer (PFE.N) in 2021 licensed the ​drug to Priovant Therapeutics, a joint company ​it created ⁠with Roivant.

Roivant owns 71% of Priovant, while Pfizer holds a 24% stake.

According to the National Institutes of Health, dermatomyositis affects ⁠fewer than ​5,000 people in the U.S.

The partners ​expect Lisraya to have U.S. market exclusivity until at least 2039.

Roivant Sciences Ltd. (ROIV) Discusses FDA Approval of LISRAYA as First Oral Targeted Therapy for Dermatomyositis Transcript

Trump Index: 6 Companies Linked to Trump’s Cabinet Worth WatchingRoivant Sciences NASDAQ: ROIV said it expects a busy second half of 2026, with a potential launch of brepocitinib in dermatomyositis, several clinical readouts and additional regulatory discussions across its pipeline.

Chief Executive Officer Matt Gline characterized the quarter as relatively quiet but said the company has advanced several priorities outlined at its investor day. Those include the anticipated brepocitinib launch, development work at Immunovant, progress in litigation-related matters and continued capital returns.

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“The next 6-12 months are in many ways busier than the prior 6-12 months for us,” Gline said on the company’s first-quarter earnings call.

Brepocitinib Launch and Pipeline Progress Roivant said brepocitinib, which is under priority FDA review for dermatomyositis, is expected to launch by the end of September if it receives approval. Gline said the commercial and patient-support teams at Priovant have been built, trained and are ready for a potential launch.

Management reiterated that it intends to pursue a “slow and steady” launch rather than focus on near-term sales metrics. Gline said the company is seeking to establish access, patient-support, institutional and physician-engagement infrastructure that can support brepocitinib across multiple potential indications beyond dermatomyositis.

Gline said physicians and patients have expressed enthusiasm for new treatment options in dermatomyositis, a condition in which patients often use multiple therapies and remain dissatisfied with available treatments. He also said Roivant expects brepocitinib’s label to include the boxed warnings associated with other JAK inhibitors, but management believes physicians will weigh those considerations against the severity of dermatomyositis and risks associated with treatments such as high-dose steroids and immunosuppressants.

The company also began enrolling patients in a Phase III trial of brepocitinib for cutaneous sarcoidosis. The 140-patient study will compare 45 milligrams of brepocitinib with placebo over 16 weeks and uses a primary endpoint of at least a 50% response on the Cutaneous Sarcoidosis Activity and Morphology Instrument, or CSAMI. Participants will undergo a mandatory steroid taper from week two through week eight.

Roivant expects top-line data from that study in 2028. Gline said the company estimates there are approximately 40,000 U.S. patients with cutaneous sarcoidosis and pointed to potential overlap with ocular and pulmonary manifestations of sarcoidosis.

Roivant also said its registrational study of brepocitinib in lichen planopilaris is enrolling “extremely well,” according to Gline. The company added lichen planopilaris as a fourth brepocitinib indication earlier this year.

Second-Half Readouts Roivant expects several important data events during the second half of 2026. These include top-line data from a Phase III study of brepocitinib in noninfectious uveitis, which Gline said could represent an opportunity comparable in size to dermatomyositis.

The company also expects top-line data from the Phase II FOCUS study of mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Management said it is looking for a clear signal in pulmonary vascular resistance, or PVR, while noting that the trial is not powered to provide a definitive assessment of six-minute walk distance.

Gline said Roivant believes inhaled vasodilation could benefit PH-ILD patients, though the Phase II study is intended to assess whether results seen in pulmonary arterial hypertension translate to the PH-ILD population. He said the company designed the study with limits on emphysema to support broad enrollment while seeking to maximize the therapy’s potential benefit.

For mosliciguat, Roivant said monotherapy data will be released before data from an open-label combination study, which began later and remains in enrollment. Management said the combination trial is intended to add safety experience and provide information that may help inform Phase III trial design.

Roivant also expects a proof-of-concept readout in cutaneous lupus erythematosus, or CLE, during the second half. The first disclosure will include 12-week data comparing a 600-milligram dose with placebo. Gline described the trial as a small fact-finding study intended to help the company assess treatment benefit and determine whether to advance the program.

Immunovant Programs and Litigation Roivant plans to provide a fuller update later this year on Immunovant’s IMVT-1402 program in difficult-to-treat rheumatoid arthritis. That update could include results from the randomized-withdrawal portion of the study, feedback from an anticipated FDA discussion and potential next steps for registrational development.

The company is also advancing IMVT-1402 in Graves’ disease. Gline said Roivant views the condition as a market with substantial unmet need, rather than one defined primarily by competition among emerging mechanisms. He said the company expects to be the first to bring an advanced therapy to the market if its program succeeds.

Separately, Roivant received the initial payment from its settlement with Moderna. Gline said the $950 million payment included approximately $770 million for Genevant and the remainder for Arbutus. He said litigation under Section 1498 remains under review at the Federal Circuit and could result in an additional $1.3 billion with a favorable outcome. Roivant also filed international lawsuits against Pfizer and BioNTech, including actions in Canada and the Unified Patent Court, during July.

Financial Position and Capital Returns Roivant reported approximately $200 million in research-and-development expense for the quarter. Non-GAAP adjusted general and administrative expense was just under $100 million, while GAAP general and administrative expense was $166 million.

The company reported cash of just under $4 billion before receipt of approximately $772 million associated with the Moderna settlement payment. Roivant repurchased about $200 million of stock during the quarter, with additional repurchases in March, after accelerating its buyback activity following the Moderna settlement announcement.

Gline said the company will continue repurchasing shares under its existing authorizations while preparing for a catalyst-rich period that could include multiple clinical readouts, regulatory filings and commercial launches through the end of 2028.

About Roivant Sciences (NASDAQ:ROIV)Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines.

The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women's health.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Roivant Sciences Ltd. (ROIV - Free Report) came out with a quarterly loss of $0.33 per share in line with the Zacks Consensus Estimate. This compares to a loss of $0.18 per share a year ago. These figures are adjusted for non-recurring items.

A quarter ago, it was expected that this company would post a loss of $0.26 per share when it actually produced a loss of $0.36, delivering a surprise of -38.46%.

Over the last four quarters, the company has surpassed consensus EPS estimates just once.

Montes Archimedes Acquisition, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $1.44 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 35.48%. This compares to year-ago revenues of $2.17 million. The company has not been able to beat consensus revenue estimates over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Montes Archimedes Acquisition shares have added about 59.5% since the beginning of the year versus the S&P 500's gain of 12.8%.

What's Next for Montes Archimedes Acquisition?While Montes Archimedes Acquisition has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Montes Archimedes Acquisition was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.35 on $3.16 million in revenues for the coming quarter and -$1.35 on $50.61 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Another stock from the same industry, Septerna, Inc. (SEPN - Free Report) , has yet to report results for the quarter ended June 2026.

This company is expected to post quarterly loss of $0.48 per share in its upcoming report, which represents a year-over-year change of +14.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Septerna, Inc.'s revenues are expected to be $20.56 million, up 17035.8% from the year-ago quarter.

Commercial preparations for brepocitinib in dermatomyositis (DM) are progressing well and on track for launch by the end of September 2026; topline data from Phase 3 study in non-infectious uveitis (NIU) expected in the second half of calendar year 2026 First patients enrolled in the Phase 3 study of brepocitinib in cutaneous sarcoidosis (CS), with topline data expected in calendar year 2028; enrollment in Part 1 of the Phase 2b/3 study in lichen planopilaris (LPP) is progressing well IMVT-1402 proof-of-concept trial in cutaneous lupus erythematosus (CLE) topline data expected in the second half of calendar year 2026; all clinical development timelines remain on track for IMVT-1402 Mosliciguat Phase 2 study in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track, with topline data expected in the second half of calendar year 2026 Genevant and Arbutus received $950 million from Moderna in July 2026 under $2.25 billion settlement, with additional $1.3 billion contingent on favorable resolution of Moderna's § 1498 appeal; filed new international lawsuits against Pfizer and BioNTech covering 21 jurisdictions Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $3.9 billion as of June 30, 2026, excluding the cash payment received from Moderna in July, supporting cash runway into profitability Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026, to report its financial results for the first quarter ended June 30, 2026, and provide a business update BASEL, Switzerland and LONDON and NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the first quarter ended June 30, 2026, and provided a business update.

Posted by Defense World Staff on Aug 4th, 2026

California State Teachers Retirement System boosted its holdings in shares of Roivant Sciences Ltd. (NASDAQ:ROIV – Free Report) by 22.9% in the 1st quarter, according to the company in its most recent Form 13F filing with the Securities & Exchange Commission. The fund owned 440,634 shares of the company’s stock after acquiring an additional 82,075 shares during the quarter. California State Teachers Retirement System owned about 0.06% of Roivant Sciences worth $12,206,000 at the end of the most recent quarter.

A number of other institutional investors and hedge funds also recently added to or reduced their stakes in ROIV. SBI Securities Co. Ltd. increased its position in shares of Roivant Sciences by 1,740.3% during the 4th quarter. SBI Securities Co. Ltd. now owns 1,233 shares of the company’s stock worth $27,000 after purchasing an additional 1,166 shares during the last quarter. Allworth Financial LP boosted its stake in Roivant Sciences by 48.1% during the third quarter. Allworth Financial LP now owns 1,795 shares of the company’s stock worth $27,000 after buying an additional 583 shares during the period. Kestra Advisory Services LLC purchased a new position in Roivant Sciences during the fourth quarter worth about $47,000. Parallel Advisors LLC increased its position in shares of Roivant Sciences by 33.7% during the first quarter. Parallel Advisors LLC now owns 2,065 shares of the company’s stock valued at $57,000 after acquiring an additional 520 shares during the last quarter. Finally, CIBC Private Wealth Group LLC raised its stake in shares of Roivant Sciences by 7,614.3% in the 4th quarter. CIBC Private Wealth Group LLC now owns 2,700 shares of the company’s stock valued at $59,000 after acquiring an additional 2,665 shares during the period. Hedge funds and other institutional investors own 64.76% of the company’s stock.

Roivant Sciences Price Performance Shares of ROIV opened at $33.32 on Tuesday. Roivant Sciences Ltd. has a 1-year low of $10.90 and a 1-year high of $37.00. The stock has a market cap of $23.97 billion, a PE ratio of -55.53 and a beta of 1.12. The firm has a fifty day moving average price of $32.70 and a 200 day moving average price of $29.17.

Analyst Ratings Changes Several research firms have recently commented on ROIV. TD Cowen raised their price target on Roivant Sciences from $38.00 to $41.00 and gave the stock a “buy” rating in a research report on Thursday, May 21st. Bank of America reiterated a “neutral” rating on shares of Roivant Sciences in a report on Friday. Weiss Ratings lowered Roivant Sciences from a “sell (d)” rating to a “sell (d-)” rating in a research note on Friday, May 22nd. Leerink Partners set a $42.00 target price on Roivant Sciences in a research report on Thursday, May 21st. Finally, Piper Sandler reissued an “overweight” rating on shares of Roivant Sciences in a research report on Thursday, May 21st. Ten equities research analysts have rated the stock with a Buy rating, one has assigned a Hold rating and one has given a Sell rating to the company. According to data from MarketBeat, the stock presently has a consensus rating of “Moderate Buy” and an average price target of $33.59.

View Our Latest Report on Roivant Sciences

Insider Activity In related news, CEO Eric Venker sold 200,000 shares of the firm’s stock in a transaction that occurred on Monday, July 27th. The stock was sold at an average price of $34.95, for a total transaction of $6,990,000.00. Following the transaction, the chief executive officer owned 1,613,063 shares in the company, valued at $56,376,551.85. This trade represents a 11.03% decrease in their position. The transaction was disclosed in a filing with the SEC, which is available through the SEC website. Also, Director Daniel Allen Gold sold 12,380 shares of Roivant Sciences stock in a transaction that occurred on Tuesday, June 30th. The stock was sold at an average price of $35.28, for a total value of $436,766.40. Following the transaction, the director directly owned 13,689,166 shares in the company, valued at approximately $482,953,776.48. This trade represents a 0.09% decrease in their position. The disclosure for this sale is available in the SEC filing. In the last three months, insiders sold 2,055,913 shares of company stock valued at $69,639,633. Insiders own 8.80% of the company’s stock.

About Roivant Sciences (Free Report)

Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines.

The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women’s health.

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Posted by Defense World Staff on Jul 25th, 2026

Bank of Nova Scotia cut its stake in Roivant Sciences Ltd. (NASDAQ:ROIV – Free Report) by 7.9% during the first quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The institutional investor owned 1,310,387 shares of the company’s stock after selling 112,613 shares during the quarter. Bank of Nova Scotia owned approximately 0.18% of Roivant Sciences worth $36,298,000 at the end of the most recent reporting period.

Several other large investors also recently bought and sold shares of ROIV. SBI Securities Co. Ltd. lifted its holdings in Roivant Sciences by 1,740.3% in the 4th quarter. SBI Securities Co. Ltd. now owns 1,233 shares of the company’s stock valued at $27,000 after purchasing an additional 1,166 shares in the last quarter. Allworth Financial LP raised its position in shares of Roivant Sciences by 48.1% during the 3rd quarter. Allworth Financial LP now owns 1,795 shares of the company’s stock valued at $27,000 after buying an additional 583 shares during the period. Parallel Advisors LLC lifted its stake in shares of Roivant Sciences by 33.7% in the 1st quarter. Parallel Advisors LLC now owns 2,065 shares of the company’s stock valued at $57,000 after purchasing an additional 520 shares during the last quarter. Kestra Advisory Services LLC acquired a new position in Roivant Sciences in the fourth quarter valued at about $47,000. Finally, Bessemer Group Inc. boosted its position in shares of Roivant Sciences by 21.8% during the 1st quarter. Bessemer Group Inc. now owns 2,465 shares of the company’s stock worth $69,000 after purchasing an additional 441 shares during the period. 64.76% of the stock is currently owned by hedge funds and other institutional investors.

Insider Buying and Selling at Roivant Sciences In other Roivant Sciences news, CEO Eric Venker sold 200,000 shares of the company’s stock in a transaction dated Wednesday, June 24th. The shares were sold at an average price of $33.16, for a total value of $6,632,000.00. Following the transaction, the chief executive officer directly owned 1,613,063 shares in the company, valued at approximately $53,489,169.08. This represents a 11.03% decrease in their position. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Melissa B. Epperly sold 17,750 shares of Roivant Sciences stock in a transaction dated Monday, June 29th. The stock was sold at an average price of $34.38, for a total transaction of $610,245.00. Following the sale, the director owned 16,474 shares of the company’s stock, valued at approximately $566,376.12. This trade represents a 51.86% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last ninety days, insiders have sold 1,855,913 shares of company stock worth $62,649,633. Corporate insiders own 10.80% of the company’s stock.

Analyst Ratings Changes Several research firms have weighed in on ROIV. HC Wainwright reaffirmed a “buy” rating and issued a $34.00 target price on shares of Roivant Sciences in a research report on Thursday, May 21st. Citigroup boosted their price target on shares of Roivant Sciences from $35.00 to $42.00 and gave the company a “buy” rating in a research report on Thursday, May 21st. Piper Sandler reissued an “overweight” rating on shares of Roivant Sciences in a research report on Thursday, May 21st. Leerink Partners set a $42.00 price target on Roivant Sciences in a research note on Thursday, May 21st. Finally, Weiss Ratings lowered Roivant Sciences from a “sell (d)” rating to a “sell (d-)” rating in a report on Friday, May 22nd. Ten analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has issued a Sell rating to the company’s stock. According to MarketBeat.com, the company presently has a consensus rating of “Moderate Buy” and a consensus target price of $33.59.

Read Our Latest Report on ROIV

Roivant Sciences Stock Down 0.3% Shares of NASDAQ:ROIV opened at $35.01 on Friday. The company has a market capitalization of $25.18 billion, a P/E ratio of -58.35 and a beta of 1.11. Roivant Sciences Ltd. has a 52-week low of $10.90 and a 52-week high of $37.00. The stock’s fifty day simple moving average is $32.24 and its 200-day simple moving average is $28.62.

Roivant Sciences Profile (Free Report)

Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines.

The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women’s health.

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BASEL, Switzerland and LONDON and NEW YORK, July 23, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026, to report its financial results for the first quarter ended June 30, 2026, and provide a business update.

April 02, 2026 05:00 ET  | Source: Roivant Sciences

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 needLPP marks the fourth indication in brepocitinib’s expanding late-stage development programMultiple 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 indicationA seamless Phase 2b/3 potentially registrational trial of brepocitinib in LPP enrolled its first subjects in March 2026Immunovant’s Phase 3 studies of batoclimab in thyroid eye disease (TED) each failed to meet their primary endpoint; safety results were consistent with previous findingsPatients 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’ diseaseImmunovant remains focused on rapid advancement of IMVT-1402 in multiple indicationsRoivant 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 https://investor.roivant.com/news-events/events. 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 https://roivant.com.

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

[email protected]

Media

Stephanie Lee

[email protected]

Roivant Sciences (NASDAQ:ROIV) outlined plans to expand development of its JAK1/TYK2 inhibitor brepocitinib into lichen planopilaris (LPP) and provided an update on a Phase III thyroid eye disease (TED) trial for batoclimab during a conference call hosted by the company.

Brepocitinib expands into lichen planopilaris Roivant CEO Matt Gline said the company is moving “with urgency” to broaden brepocitinib across multiple indications, focusing on orphan immunology diseases with high unmet need, aligned biology for dual JAK1/TYK2 inhibition, and limited or no approved options. Alongside existing programs in dermatomyositis, non-infectious uveitis, and cutaneous sarcoidosis, Gline announced LPP as a new addition, describing it as “a fourth leg to the stool.”

Gline characterized LPP as a “severe and deeply unpleasant disease,” describing it as a highly morbid inflammatory scalp disorder that targets the permanent portion of the hair follicle, leading to generally irreversible hair loss and scarring that “can be permanently disfiguring.” He also cited intense symptoms including pain, itch, burning, redness, and scaling. He said there are no FDA-approved therapies and that patients often require chronic, aggressive, multimodal treatment that is frequently poorly effective.

Management noted the company views LPP as an “orphan-sized” opportunity, with Gline estimating “probably up to 100,000 U.S. patients,” and said the literature suggests prevalence and diagnosis are increasing over time.

Priovant details disease burden and biological rationale Ben Zimmer, CEO of Priovant, said LPP carries substantial burden beyond scalp symptoms, citing an association with increased risk of severe comorbidities, “including both skin cancer and other autoimmune diseases.” He added that clinicians often attempt multiple off-label therapies but that outcomes are limited and discontinuations are common due to tolerability and efficacy.

Zimmer said Priovant believes brepocitinib is well matched to LPP biology, describing the condition as driven primarily by “Th1 polarized T cell aberrant behavior.” He noted that interferon gamma and IL-12 are critical Th1 cytokines and that a JAK1/TYK2 inhibitor can suppress signaling of both. Zimmer pointed to experience in cutaneous sarcoidosis—another Th1-driven condition studied with brepocitinib—as supportive of the mechanistic fit.

Zimmer also referenced case reports and investigator-initiated studies of JAK1 and TYK2 inhibitors as clinical validation for the mechanism. He discussed a small, placebo-controlled investigator-initiated trial at Mount Sinai that used the LPPAI endpoint, which he described as “a generally noisy instrument” that is not preferred by clinicians. While urging caution about overinterpreting a small dataset, Zimmer said the broader takeaway supported proof-of-concept and helped underpin the company’s decision to move quickly.

Zimmer emphasized biomarker findings from that study, saying the “most powerful” aspect was evidence of brepocitinib activity on multiple markers of Th1-driven inflammation, including interferon gamma, IL-12, and chemokines such as CCL5.

Combined Phase IIb/III trial underway; IGA endpoint planned Gline said the LPP program has effectively begun as a “direct to registrational combined Phase IIb/III program,” with the study getting underway “last month.” He described a 72-patient Phase IIb portion that will transition immediately into a pivotal Phase III portion under a largely continuous design. The Phase III sample size is expected to be approximately 270 patients, with a sample size re-estimation after Phase IIb.

Management said the design is intended to support endpoint validation and regulatory alignment, while maintaining a pace closer to a straight-to-registrational program. Gline said the company is not yet providing enrollment timeline guidance but noted enthusiasm from investigators and patient communities.

On endpoints, Zimmer said Priovant is using a more structured approach than LPPAI. He described LPPAI as a composite measure with both physician-assessed and patient-reported components, but with limited definitions for raters. The company’s approach will include an investigator global assessment (IGA) focused on erythema and scale using defined criteria, with secondary endpoints to measure symptoms such as pain and itch using numerical rating scales.

In Q&A, Gline and Zimmer indicated the Phase IIb primary endpoint is expected to be an IGA 0/1 response with a two-point reduction, and said they expect—though cannot fully confirm until FDA discussions after Phase IIb—that the Phase III primary endpoint will match. Zimmer noted that placebo rates for rigorous IGA endpoints in inflammatory skin disorders tend to be low, particularly when requiring improvement to 0/1.

On background therapies, Gline said medications were washed out pre-baseline in the Mount Sinai investigator-initiated trial and highlighted that LPP patients often have polypharmacy. Zimmer said the registrational program plans to wash patients out of background medications “quite aggressively,” consistent with Priovant’s approach in other trials.

Batoclimab Phase III TED trial misses primary endpoint; Graves’ signals discussed Gline also addressed topline Phase III results in TED for batoclimab, Immunovant’s first-generation anti-FcRn antibody, stating the studies “failed to meet their primary endpoint.” He said the TED program was effectively the last readout for the first-generation molecule, with future development focused on IMVT-1402.

The TED primary endpoint was a ≥2 mm proptosis responder rate, which the trial did not achieve. Gline said the company is not pursuing further progress in TED with batoclimab, while noting the dataset provided scientific insights. He described the trial design as 12 weeks of high-dose batoclimab aimed at deep IgG suppression followed by 12 weeks of lower dosing. He said performance was generally better during the initial 12-week high-dose period than during the subsequent lower-dose period, a pattern he said was consistent across endpoints.

Gline said the trial showed “meaningful numerical separation” from placebo on change in proptosis at week 12, and noted that when pooling two TED studies, that measure was “nominally significant” in a post-hoc analysis, while emphasizing the limitations of such analyses. He added that proptosis improvements diminished between weeks 12 and 24 after dose reduction.

Management also highlighted results in a small subset of hyperthyroid patients included within TED enrollment criteria. Gline said there were about 20 hyperthyroid patients across active treatment arms in the pooled dataset. He reported a 75% mean IgG reduction and an 80% responder rate by a thyroid hormone definition (T3 and T4 below the upper limit of normal without increased antithyroid drug dosing), which he said matched the responder rate observed in a prior Phase II Graves’ study at week 12. He also said responder rates declined in the second 12-week period as IgG suppression lessened.

In response to analyst questions, Gline said hyperthyroid patients in the TED studies performed “somewhat better” on proptosis than the overall TED population. He also noted that antithyroid drug dose titration was not allowed in TED, limiting insight into real-world dose adjustments in that setting.

Gline said enrollment in the ongoing IMVT-1402 Graves’ program is “going well,” and reiterated expectations that both Graves’ studies will read out next year. He noted the Graves’ program excludes moderate to severe TED patients and is focused on endocrinology-driven sites, though the company expects to assess ocular symptom outcomes in Graves’ as well.

About Roivant Sciences (NASDAQ:ROIV) Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines.

The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women’s health.

Featured Stories Five stocks we like better than Roivant Sciences

Investors might want to bet on Roivant Sciences Ltd. (ROIV - Free Report) , as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.

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As such, the Zacks rating upgrade for Montes Archimedes Acquisition is essentially a positive comment on its earnings outlook that could have a favorable impact on its stock price.

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Earnings Estimate Revisions for Montes Archimedes AcquisitionThis company is expected to earn -$1.07 per share for the fiscal year ending March 2026, which represents no year-over-year change.

Analysts have been steadily raising their estimates for Montes Archimedes Acquisition. Over the past three months, the Zacks Consensus Estimate for the company has increased 7.4%.

Bottom LineUnlike the overly optimistic Wall Street analysts whose rating systems tend to be weighted toward favorable recommendations, the Zacks rating system maintains an equal proportion of "buy" and "sell" ratings for its entire universe of more than 4,000 stocks at any point in time. Irrespective of market conditions, only the top 5% of the Zacks-covered stocks get a "Strong Buy" rating and the next 15% get a "Buy" rating. So, the placement of a stock in the top 20% of the Zacks-covered stocks indicates its superior earnings estimate revision feature, making it a solid candidate for producing market-beating returns in the near term.

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The upgrade of Montes Archimedes Acquisition to a Zacks Rank #2 positions it in the top 20% of the Zacks-covered stocks in terms of estimate revisions, implying that the stock might move higher in the near term.

Posted by Defense World Staff on Apr 15th, 2026

Roivant Sciences Ltd. (NASDAQ:ROIV – Get Free Report) has earned a consensus recommendation of “Moderate Buy” from the eleven brokerages that are covering the stock, MarketBeat Ratings reports. One equities research analyst has rated the stock with a sell rating, one has given a hold rating and nine have given a buy rating to the company. The average 12-month price objective among brokerages that have issued ratings on the stock in the last year is $29.50.

ROIV has been the topic of a number of analyst reports. Weiss Ratings downgraded shares of Roivant Sciences from a “hold (c-)” rating to a “sell (d)” rating in a research note on Monday, February 9th. HC Wainwright lifted their target price on shares of Roivant Sciences from $33.00 to $34.00 and gave the stock a “buy” rating in a research note on Wednesday, March 4th. Citigroup lifted their target price on shares of Roivant Sciences from $26.00 to $35.00 and gave the stock a “buy” rating in a research note on Tuesday, February 10th. Jefferies Financial Group reaffirmed a “buy” rating on shares of Roivant Sciences in a research note on Tuesday, March 3rd. Finally, Sanford C. Bernstein began coverage on shares of Roivant Sciences in a research note on Friday, March 20th. They issued an “outperform” rating and a $35.00 price target on the stock.

View Our Latest Report on ROIV

Insiders Place Their Bets In other news, CAO Jennifer Humes sold 13,538 shares of the business’s stock in a transaction that occurred on Wednesday, April 8th. The shares were sold at an average price of $28.37, for a total value of $384,073.06. Following the sale, the chief accounting officer directly owned 84,191 shares of the company’s stock, valued at approximately $2,388,498.67. The trade was a 13.85% decrease in their position. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available at this hyperlink. Also, Director Melissa B. Epperly sold 41,861 shares of the business’s stock in a transaction that occurred on Monday, March 16th. The shares were sold at an average price of $28.68, for a total transaction of $1,200,573.48. Following the completion of the sale, the director directly owned 15,804 shares in the company, valued at $453,258.72. This trade represents a 72.59% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. In the last ninety days, insiders sold 4,595,624 shares of company stock worth $124,848,136. Insiders own 10.80% of the company’s stock.

Institutional Investors Weigh In On Roivant Sciences A number of institutional investors and hedge funds have recently made changes to their positions in the stock. Creek Drive Management Group LLC purchased a new stake in shares of Roivant Sciences in the 4th quarter valued at approximately $3,689,000. Hsbc Holdings PLC purchased a new stake in shares of Roivant Sciences in the 4th quarter valued at approximately $896,000. Pacer Advisors Inc. raised its stake in shares of Roivant Sciences by 24.0% in the 4th quarter. Pacer Advisors Inc. now owns 70,259 shares of the company’s stock valued at $1,525,000 after acquiring an additional 13,609 shares during the period. Dorsey Wright & Associates purchased a new stake in shares of Roivant Sciences in the 4th quarter valued at approximately $8,162,000. Finally, Invesco Ltd. raised its stake in shares of Roivant Sciences by 28.9% in the 4th quarter. Invesco Ltd. now owns 2,281,487 shares of the company’s stock valued at $49,508,000 after acquiring an additional 512,129 shares during the period. 64.76% of the stock is owned by hedge funds and other institutional investors.

Roivant Sciences Price Performance Shares of ROIV stock opened at $29.12 on Wednesday. The firm’s 50-day moving average is $27.68 and its two-hundred day moving average is $22.94. Roivant Sciences has a 12 month low of $9.90 and a 12 month high of $30.33. The company has a market capitalization of $20.84 billion, a PE ratio of -24.89 and a beta of 1.20.

About Roivant Sciences (Get Free Report)

Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines.

The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women’s health.

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DURHAM, N.C., May 11, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT) today announced that it will report its financial results for the fourth quarter and fiscal year ended March 31, 2026, and provide a business update at 8:00 a.m.

Roivant Sciences Ltd. (ROIV) Presents at Bank of America Global Healthcare Conference 2026 Transcript

BASEL, Switzerland and LONDON and NEW YORK, May 20, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2026, and provided a business update.

Trump Index: 6 Companies Linked to Trump’s Cabinet Worth WatchingRoivant Sciences NASDAQ: ROIV executives used the company’s fourth-quarter earnings call to highlight new open-label data for IMVT-1402 in difficult-to-treat rheumatoid arthritis, upcoming pulmonary hypertension data for mosliciguat and continued preparation for a potential brepocitinib launch in dermatomyositis.

Chief Executive Matt Gline called the company’s recent period “a pretty wild 12 months,” citing progress across development programs and the previously announced $2.25 billion settlement with Moderna. Gline said Roivant expects to receive the first $950 million upfront portion of that settlement in July.

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IMVT-1402 Shows Open-Label Activity in Refractory RA The most prominent update centered on preliminary data from the open-label portion of the 1402 study in difficult-to-treat rheumatoid arthritis, or D2T RA. Gline described the results as “surprisingly good,” while cautioning that the data came from an open-label phase of the trial.

The study enrolled heavily refractory patients who had failed steroids and DMARDs as well as at least two advanced lines of therapy. Gline said 65% of patients had failed JAK inhibitors, and that “basically every single one” of those patients had also failed a TNF inhibitor. The study also required autoantibody positivity using ACPA criteria.

In the preliminary period 1 data, Roivant reported that roughly 73% of evaluable patients achieved an ACR20 response. More than half achieved ACR50, and more than one-third achieved ACR70. Gline said the depth of response was especially notable because placebo responses are less common at the ACR50 and ACR70 levels.

“It feels to us like looking at this data, there’s something going on that’s meaningful and interesting with this drug,” Gline said.

Gline said the responses were “basically fully preserved” in the subset of patients who had prior JAK inhibitor exposure, a group he characterized as both JAK- and TNF-experienced. He said the findings support the biological thesis that ACPA positivity may represent a mechanism distinct from other anti-inflammatory approaches.

The randomized withdrawal portion of the study is still ongoing. Gline said more than half of patients remain on study treatment, and the company does not yet have data from period 2. He also noted that period 2 may be harder to interpret because patients with deep ACR50 or ACR70 responses may take time to lose an ACR20 response after withdrawal.

Roivant expects to share additional analysis, including patient-level data and feedback from discussions with the U.S. Food and Drug Administration, in the second half of the year. Gline said the company is preparing to discuss the data with regulators and hopes to outline next steps for the program.

Mosliciguat Data Expected in Second Half Roivant also provided a detailed preview of mosliciguat, an inhaled soluble guanylate cyclase, or sGC, activator being studied in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Drew Fromkin, CEO of Pulmovant, said mosliciguat is designed to activate sGC directly in the lungs and potentially address both pulmonary vascular disease and lung parenchymal disease.

Fromkin said Bayer previously studied mosliciguat in 170 participants, including healthy volunteers and pulmonary hypertension patients, before Roivant’s program advanced into PH-ILD. In phase I-B data, he said a single dose produced a mean pulmonary vascular resistance reduction of more than 30% and a mean peak reduction of about 38%. He also said the drug was well-tolerated, with mild to moderate treatment-emergent adverse events and no clinically meaningful systemic blood pressure or heart rate effects.

The ongoing PHocus phase II study enrolled 135 patients, above its target of 120. Fromkin said more than 95% of participants reached and sustained the 4-milligram dose through week 16. The primary endpoint is change from baseline in pulmonary vascular resistance at week 16, with secondary measures including six-minute walk distance and NT-proBNP.

Gline emphasized that the study is not powered to show a statistically significant benefit on six-minute walk distance. He said Roivant is primarily looking for confirmation of dosing, safety and pulmonary vascular resistance effects in the patient population.

Brepocitinib Launch Preparation Continues Roivant also updated investors on brepocitinib, which Gline said could potentially launch in dermatomyositis by the end of September if the FDA review proceeds as expected. He said the company is engaged in payer discussions, physician outreach, specialty pharmacy partnerships and unbranded patient engagement.

Gline said brepocitinib was awarded breakthrough therapy designation and rare therapy designation for cutaneous sarcoidosis. Roivant expects a phase III study in cutaneous sarcoidosis to begin this year. The company also recently announced lichen planopilaris, or LPP, as a fourth indication for brepocitinib, and Gline said that study is already enrolling.

For dermatomyositis, Gline described a high unmet need, noting that many patients rely on steroids, IVIG or off-label therapies. He said phase III brepocitinib data were published in the New England Journal of Medicine in March, which he called a testament to the importance and quality of the study.

Financial Position and Upcoming Milestones Gline said Roivant ended March 31 with $4.3 billion in cash and equivalents, before receipt of the Moderna settlement payment, and no debt. He also said the company continued to retire shares during the quarter.

Key milestones discussed on the call include:

Potential brepocitinib launch in dermatomyositis by the end of September, pending FDA action. Phase III top-line data in noninfectious uveitis expected in the second half of the year. Mosliciguat phase II-B top-line data in PH-ILD expected in the second half of 2026. Additional IMVT-1402 analysis in D2T RA, including FDA feedback, expected in the second half. IMVT-1402 data in Graves’ disease and myasthenia gravis expected in 2027. Gline said Roivant’s portfolio has “as much in the windshield as in the rearview mirror,” pointing to multiple data readouts and potential commercial activities ahead.

About Roivant Sciences NASDAQ: ROIVRoivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines.

The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women's health.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Roivant (ROIV) remains a Buy as its unique 'vant' structure rapidly advances and monetizes blockbuster assets, notably through Immunovant's IMVT-1402 in rheumatoid arthritis. IMVT-1402 delivered strong Phase 2 efficacy in difficult-to-treat rheumatoid arthritis, with ACR20/50/70 rates of 72.7%, 54.5%, and 35.8%, respectively. ROIV's financial position is robust, ending the quarter with $4.3 billion in cash and a management-asserted runway to profitability.

Roivant Sciences Ltd. (ROIV) Presents at Jefferies Global Healthcare Conference 2026 Transcript