Společnost Roivant Sciences oznámila, že brepocitinib ve studiích fáze III u neinfekční uveitidy splnil primární i všechny sekundární cílové ukazatele; k selhání léčby došlo u 33,5 % pacientů oproti 78 % ve skupině s placebem.
Trump Index: 6 Companies Linked to Trump’s Cabinet Worth WatchingRoivant Sciences NASDAQ: ROIV reported positive Phase III results from its CLARITY-1 and CLARITY-2 studies evaluating brepocitinib, which the company referred to as Brepo, in noninfectious uveitis (NIU), an inflammatory eye disease that can result in vision loss.
Matt Gline, Roivant’s chief executive officer, said the trials met their primary endpoint of time to treatment failure as well as all secondary endpoints in each individual study and in pooled analyses. The studies compared brepocitinib with placebo over a 48-week treatment period.
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“We got the largest efficacy benefit ever seen for a non-steroidal therapy,” Gline said during the company’s call, while noting that comparisons with prior studies of other treatments are cross-trial comparisons and subject to limitations.
Primary Endpoint and Steroid-Free Disease Control In both CLARITY trials, the median time to treatment failure was not reached among brepocitinib-treated patients by the end of the 48-week study period, because more than half of those patients had not experienced treatment failure. In comparison, median time to treatment failure was approximately 12 weeks in one placebo study and 13 weeks in the other, according to Roivant.
The company said the studies used an aggressive corticosteroid taper. Patients began treatment with 60 milligrams of steroids for two weeks and were fully tapered off steroids by week eight.
In pooled data, 33.5% of brepocitinib-treated patients experienced treatment failure by the end of the study, compared with 78% of placebo-treated patients. Roivant said the benefit was consistent across subgroups, including patients previously treated with tumor necrosis factor, or TNF, therapies.
Gline said roughly one-third of patients enrolled across the trials had prior TNF exposure. In the subset of patients with prior TNF experience, the company said brepocitinib’s treatment-failure results were comparable with results in the broader trial population.
Roivant also highlighted steroid-free quiescence, a measure of disease control in which patients have a “quiet eye” without corticosteroid treatment. The company said more than 60% of patients achieved steroid-free quiescence in one study, compared with roughly 20% of placebo patients.
Macular Edema, Imaging and Patient-Reported Outcomes Roivant said the treatment demonstrated separation from placebo on fluorescein angiography measures, an imaging approach used by physicians to monitor uveitis. The company also reported clinically meaningful resolution of macular edema among patients who entered the studies with the condition.
About one-third of the study population had macular edema at baseline. Of those patients, Roivant said approximately 40% in CLARITY-1 and slightly more than 40% in CLARITY-2 achieved clinically meaningful resolution by the end of the study, compared with low rates in the placebo groups.
Ben Zimmer, chief executive officer of Priovant, said macular edema results could represent a differentiating feature versus adalimumab and other TNF therapies used off-label in the disease. However, he said it remains to be determined what information could be included in a potential product label.
The company also reported improvement versus placebo in a visual function questionnaire beginning at week six in both trials. The patient-reported measure included domains such as general vision, pain, near and distance activities, mental health, dependency and driving.
Safety, Regulatory Plans and Commercial Discussion Gline said brepocitinib’s safety profile was well tolerated and consistent with prior studies of the drug, the JAK inhibitor class and the existing label for LISRAYA. He said patients with NIU often otherwise rely on high doses of background steroids, which can be difficult to use over extended periods.
Roivant plans to submit a supplemental new drug application for brepocitinib in NIU during the first half of 2027. The company did not provide details regarding potential review timing, saying it would update investors after submission acceptance and receipt of a PDUFA date.
Gline said NIU is the third leading cause of blindness in the United States and described a substantial need for new treatment options. He cited estimates of between 70,000 and 190,000 patients with posterior or pan-uveitis from various causes, while later noting that approximately 50,000 patients are systemically treated today.
The company expects to discuss the NIU commercial opportunity, patient population and physician-call strategy in greater detail at an Investor Day scheduled for Dec. 9 in New York City. Gline said a future NIU launch would require a commercial effort distinct from the organization supporting LISRAYA in dermatomyositis, though some patient-support infrastructure could be reused.
Roivant said brepocitinib is also being developed in other indications, including cutaneous sarcoidosis and lichen planopilaris, with both programs enrolling patients.
About Roivant Sciences (NASDAQ:ROIV)Roivant Sciences Ltd. NASDAQ: ROIV is a biopharmaceutical company focused on discovering, developing and commercializing medicines. The company organizes its activities through subsidiaries and partner companies, often referred to as “Vants,” which specialize in particular therapeutic areas and stages of drug development.
Roivant's research and development activities have included immunology, dermatology, women's health, rare diseases and other specialty-care fields. Its portfolio has included Vtama (tapinarof) cream, a nonsteroidal topical treatment approved in the United States for plaque psoriasis and atopic dermatitis.
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Roivant Sciences uvedla, že v příštích 12 měsících čeká na spuštění LISRAYA a na klíčová klinická data pro brepocitinib i IMVT-1402. Po pozitivních datech z fáze II u mosliciguatu zároveň rozšiřuje program pro plicní hypertenzi.
Trump Index: 6 Companies Linked to Trump’s Cabinet Worth WatchingRoivant Sciences NASDAQ: ROIV CEO Matthew Gline outlined the company’s priorities for the next 12 months, including the launch of LISRAYA, upcoming clinical data for brepocitinib and Immunovant’s IMVT-1402, and expansion of its pulmonary hypertension program.
Gline said Roivant recently received approval for brepocitinib, now marketed as LISRAYA, in dermatomyositis and reported positive Phase II data for once-daily inhaled soluble guanylate cyclase stimulator mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD.
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LISRAYA Launch and Uveitis Readout Roivant is in the early stages of the LISRAYA launch in dermatomyositis, where Gline said the company’s approach remains “slow and steady.” He said it was too soon, roughly three weeks after launch, to draw conclusions regarding prescriptions, reimbursement or coverage, although he cited enthusiasm from key opinion leaders.
“We’re focused on the launch itself, and focused on net sales as the ultimate judgment,” Gline said, adding that Roivant has not committed to specific launch metrics it will disclose on earnings calls.
The company also expects Phase III data for brepocitinib in non-infectious uveitis during the second half of the year. Gline said Roivant had not yet seen the data. If successful, the program could support a second registered indication for LISRAYA.
He described non-infectious uveitis as the third-leading cause of blindness in the United States and said there has been limited therapeutic innovation. Gline said Roivant’s Phase II results compared favorably with historical HUMIRA data, though he noted that the comparison was across trials. He expects a base-case commercial position in patients whose disease is refractory to TNF therapies, while stronger data could support use earlier in treatment.
Immunovant Programs Focus on RA, Lupus and Graves’ Disease Later this year, Roivant expects to provide updates on IMVT-1402, an anti-FcRn antibody being developed through Immunovant, including randomized Phase II data in difficult-to-treat rheumatoid arthritis and headline data from a cutaneous lupus erythematosus, or CLE, proof-of-concept study.
Gline said the rheumatoid arthritis study enrolled patients who had failed at least two biologic classes. In the open-label portion, about 70% of patients achieved an ACR20 response, about 50% achieved ACR50 and about 35% achieved ACR70, according to Gline. He said the depth of those responses could make the randomized withdrawal portion of the trial harder to interpret, because patients would need to lose substantial responses to meet the primary endpoint.
Roivant’s principal objective for the randomized data is to avoid findings that would prevent a Phase III program, Gline said. The larger question is the potential regulatory path, including the size and number of studies the Food and Drug Administration may require for a late-line rheumatoid arthritis population with limited treatment options.
For CLE, Gline characterized the study as an “option bet” rather than a central part of the company’s investment thesis. He said Roivant would need to see strong data to justify a Phase III investment, given a growing competitive field and the potential dosing advantages of other mechanisms. He also said a small CLE study would not independently validate or invalidate FcRn inhibition across lupus-spectrum diseases.
Graves’ disease represents a major 2027 catalyst for IMVT-1402. Gline said the biology is straightforward because pathogenic antibodies drive the disease, and he described the company’s Phase II results as unequivocal. However, he also noted operational and endpoint risks, including limited modern trial precedent in Graves’ disease and the complexity of anti-thyroid drug titration.
Roivant is studying patients who remain uncontrolled on anti-thyroid drugs or cannot discontinue them because of side effects. Gline said the company estimates there are approximately 350,000 uncontrolled Graves’ disease patients in the U.S. and approximately 20,000 patients annually who undergo thyroid removal surgery.
In Phase II, he said nearly 60% of patients were able to discontinue or meaningfully reduce anti-thyroid drugs while achieving thyroid hormone normalization. He also said 17 of 21 patients remained controlled six months after discontinuing therapy. One Phase III study includes responder re-randomization intended to generate placebo-adjusted remission data.
Mosliciguat and Pipeline Expansion Following the positive PH-ILD Phase II result for mosliciguat, Roivant is reassessing the sequence and prioritization of additional indications. Gline said the company began its Phase III study at risk about six months earlier to avoid delays if the data were positive.
He said Roivant generally does not disclose a new indication until a study has begun, partly because FcRn development is competitive and preserving a lead can be valuable. As current programs complete studies, including non-infectious uveitis and Immunovant’s Graves’ disease and myasthenia gravis trials, Gline said the company expects capacity to initiate further studies across its portfolio.
On business development and potential asset sales, Gline said Roivant’s default strategy is to build a larger, durable company around its current pipeline rather than sell core programs. Still, he said the company remains economically driven and would consider sufficiently attractive offers.
About Roivant Sciences (NASDAQ:ROIV)Roivant Sciences Ltd. is a biopharmaceutical company focused on discovering, developing and commercializing medicines for patients with significant unmet medical needs. The company concentrates on areas including immunology, dermatology, oncology and other specialty conditions, using a combination of internally developed programs, external licensing and strategic acquisitions.
Roivant organizes many of its drug-development activities through subsidiary companies known as “Vants.” These businesses are designed to advance individual therapeutic programs or groups of related assets, while Roivant provides operational, scientific and strategic support.
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Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet Immunovant’s internal bar to continue development of IMVT-1402 in CLEIMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studiesAll other clinical development timelines remain on track BASEL, Switzerland and LONDON and NEW YORK, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced topline results from Period 1 of Immunovant’s proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE).
The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE.
“On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care. Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant.
Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402 across multiple autoimmune diseases with significant unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease.
About the Proof-of-Concept Study of IMVT-1402 in CLE
The proof-of-concept clinical study (NCT06980805) of IMVT-1402 (imeroprubart) in CLE is a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy of IMVT-1402 in adult patients with CLE. The study enrolled 57 patients. In Period 1, patients were randomized to IMVT-1402 vs. placebo for a 12-week treatment period. The primary endpoint was the percent change from Period 1 baseline in CLASI-A score at Week 12.
About Immunovant
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.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.
Roivant uvedl, že po schválení brepocitinibu jako LISRAYA se nyní soustředí na úspěšný rozjezd prodeje a na další klinická data v příštích 12 měsících.
Roivant Sciences Ltd. (ROIV) Bank of America Global Healthcare Conference 2026 September 22, 2026 8:20 AM EDT
Company Participants
Matthew Gline - CEO & Director
Conference Call Participants
Richard Wagner - BofA Securities, Research Division
Presentation
Richard Wagner
BofA Securities, Research Division
Good afternoon. Welcome back from lunch. To introduce myself, my name is Richard Wagner. I work with Jason Gerberry on the U.S. large-cap pharma names. I'm based in London. On behalf of my colleagues, Chi Fong and Dina Ramadane, covering analysts for Roivant and Immunovant, respectively, I'm pleased to welcome Matthew Gline, CEO of Roivant for a 40-minute fireside chat.
Matthew Gline
CEO & Director
Thank you, Richard.
Question-and-Answer Session
Richard Wagner
BofA Securities, Research Division
Roivant has achieved several key milestones this year, including positive Phase II readout of your once-daily inhaled sGC mosliciguat in PH-ILD and approval of your TYK2 JAK inhibitor, brepocitinib in dermatomyositis. We still have multiple readouts coming up before year-end. To help level set the discussions, what would be the company's top priorities in the next 12 months?
Matthew Gline
CEO & Director
Yes, perfect. So look, it's been a period of a lot of progress for us. It's been a great 12 months behind. We just, as you mentioned, got brepocitinib, now LISRAYA approved, and we're making some real progress on the SGC front on the pulmonary hypertension franchise. Look, coming up the next 12 months, very busy 12 months ahead. Obviously, one of the most important things for us is with brepocitinib now in the market, we're in the early innings of that launch, but we want to go as well as we possibly can have it. And so there's a lot of work going into making that successful.
We have some major clinical data coming in brepocitinib, including between now
Roivant uvedl, že experimentální lék mosliciguat splnil hlavní cíle středně pokročilé klinické studie u plicní hypertenze spojené s plicním onemocněním. Akcie v premarketu vzrostly asi o 20 %.
Roivant (ROIV.O) said on Tuesday its experimental drug met the main goals of a mid-stage study in patients with high blood pressure associated with a type of lung disease, sending shares up about 20% in premarket trading.
Roivant has been expanding its late-stage pipeline after winning U.S. approval last month for skin and muscle disease treatment Lisraya.
The drug developer said the experimental drug, mosliciguat, met the study's main goal, reducing pressure and resistance in lung blood vessels by 56.3% compared with placebo after 16 weeks of treatment.
Pulmonary hypertension develops in patients with interstitial lung disease when scarring damages blood vessels in the lungs, forcing the heart to work harder to pump blood.
Mosliciguat also met secondary goals, the company said, helping patients walk 35.2 meters farther in a six-minute walking test compared with placebo after 16 weeks.
A blood test marker linked to heart strain fell 53.2% compared with placebo at Week 16.
Benefits continued through Week 24, with patients walking 52.7 meters farther than those on placebo and showing further reductions in the heart-stress marker.
The trial enrolled 135 patients across 87 sites in 20 countries.
Treatment options for the condition currently include inhaled treprostinil products such as United Therapeutics' (UTHR.O) Tyvaso and Tyvaso DPI and Liquidia's Yutrepia, as well as off-label use of PDE5 inhibitors such as Viatris' (VTRS.O) Viagra and Lilly's (LLY.N) Cialis, which help improve blood flow through the lungs.
Roivant has already started a late-stage study and plans to enroll about 375 patients worldwide, it said.
Pulmovant oznámil, že předběžné výsledky fáze 2 studie PHocus s mosliciguatem u pacientů s PH-ILD představí na kongresu ERS 8. září 2026. Studie zahrnovala 135 dospělých účastníků.
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.
Priovant oznámil, že brepocitinib ve fázi 3 VALOR přinesl u dermatomyozitidy rychlé a trvalé zlepšení kožních příznaků oproti placebu. Do 52. týdne dosáhlo 45,7 % pacientů „čisté“ nebo „téměř čisté“ kůže versus 21,8 % u placeba.
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.
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.
DURHAM, N.C., Aug. 27, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics 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.
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.
About Priovant
Priovant Therapeutics is a biotechnology company dedicated to developing and commercializing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company’s commercial product, LISRAYA™ (brepocitinib) is the first and only targeted oral therapy approved for the treatment of adults with dermatomyositis. Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, 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.
Roivant Sciences oznámila výsledky za 1. čtvrtletí fiskálního roku 2026, které skončilo 30. června 2026. Na konferenčním hovoru vedení představilo finanční výsledky a výhled.
Roivant Sciences Ltd. (ROIV) Q1 2026 Earnings Call August 6, 2026 8:00 AM EDT
Company Participants
Stephanie Lee Griffin - Chief Operating Officer of Roivant Platforms
Matthew Gline - CEO & Director
Conference Call Participants
Brian Chen
David Risinger - Leerink Partners LLC, Research Division
Samantha Semenkow - Citigroup Inc., Research Division
Prakhar Agrawal - Cantor Fitzgerald & Co., Research Division
Andy Chen - Wolfe Research, LLC
Yatin Suneja - Guggenheim Securities, LLC, Research Division
Yaron Werber - TD Cowen, Research Division
Thomas Smith - Leerink Partners LLC, Research Division
Yasmeen Rahimi - Piper Sandler & Co., Research Division
Samuel Slutsky - LifeSci Capital, LLC, Research Division
Alexander Thompson - Stifel, Nicolaus & Company, Incorporated, Research Division
Presentation
Operator
Good day, and thank you for standing by. Welcome to Roivant First Quarter 2026 Earnings Conference Call. [Operator Instructions]
Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee. Thank you. Please go ahead.
Stephanie Lee Griffin
Chief Operating Officer of Roivant Platforms
Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investor.roivant.com.
We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties.
Priovant oznámil zařazení prvních pacientů do fáze 3 studie BEACON+ s brepocitinibem u kožní sarkoidózy. Studie má zahrnout asi 140 pacientů a data se očekávají v roce 2028.
August 06, 2026 07:00 ET | Source: Roivant Sciences
CS is a highly morbid, chronic, and disfiguring condition with no approved therapiesBrepocitinib is the first investigational therapy to generate a positive result in a placebo-controlled CS study (Phase 2 BEACON) and has received FDA Breakthrough Therapy Designation for CSGlobal Phase 3 study (BEACON+) is underway, evaluating brepocitinib 45 mg once daily against placebo in 140 patients across approximately 70 sites globally; BEACON+ topline data expected in calendar year 2028Brepocitinib’s development program now includes four indications with ongoing or successfully completed registrational trials: dermatomyositis (DM), non-infectious uveitis (NIU), lichen planopilaris (LPP), and CS; potential NDA approval and product launch in DM expected by the end of September 2026 DURHAM, N.C., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Priovant today announced that the first patients have been enrolled in the Phase 3 study evaluating brepocitinib in cutaneous sarcoidosis (CS). This follows brepocitinib’s Phase 2 study, the first positive placebo-controlled study in CS, which led to FDA Breakthrough Therapy Designation.
The Phase 3 study (BEACON+) will be conducted as a Part B to the positive Phase 2 BEACON trial. BEACON+ will enroll approximately 140 patients with cutaneous sarcoidosis across approximately 70 sites globally. Patients will be randomized 3:2 between brepocitinib 45mg once daily and placebo. The primary endpoint is the proportion of patients achieving a 50% or greater reduction in the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity Score (CSAMI-A) at Week 16. In Phase 2, 77% of brepocitinib 45mg patients achieved this endpoint compared to 0% of placebo patients. Topline data from the BEACON+ study is expected in calendar year 2028.
CS is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in the United States. The condition disproportionately impacts Black Americans. Unlike many inflammatory skin diseases, inadequately treated cutaneous sarcoidosis can rapidly cause permanent scarring and destruction of bone, cartilage, and hair follicles. Despite this significant unmet therapeutic need, there are currently no FDA-approved therapies for CS.
“Our vision is to establish brepocitinib as a leading treatment option across multiple rare diseases with high patient burden and few or no alternative therapies,” said Ben Zimmer, Priovant CEO. “The potential upcoming approval and launch of brepocitinib in dermatomyositis later this quarter would be an important milestone toward that vision. We are equally committed to rapidly advancing brepocitinib’s development across multiple additional diseases where patients have a similar urgent need for new treatment options, and the initiation of our CS Phase 3 study reflects that commitment.”
With BEACON+ underway, brepocitinib’s orphan disease development program now includes four indications with ongoing or successfully completed registrational trials. In dermatomyositis (DM), brepocitinib’s NDA is currently under Priority Review with FDA with a PDUFA date later this quarter, following the positive Phase 3 VALOR readout. In non-infectious uveitis (NIU), the Phase 3 CLARITY trial is anticipated to read out later this year. In addition to the Phase 3 BEACON+ study, Priovant is also actively enrolling a Phase 2/3 study evaluating brepocitinib in lichen planopilaris (LPP). All are indications with very high disease burden, risk of permanent organ damage if left untreated, and few or no FDA-approved therapies.
About Priovant
Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a first-in-class, selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12 and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis. The New Drug Application for brepocitinib in dermatomyositis is under review at FDA. Brepocitinib is also being evaluated in a Phase 3 program in non-infectious uveitis, a Phase 3 program in cutaneous sarcoidosis, and a Phase 2b/3 program in lichen planopilaris. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.
Roivant uvedl, že komerční přípravy brepocitinibu pro dermatomyozitidu postupují podle plánu a uvedení na trh čeká do konce září 2026. Firma měla k 30. červnu 2026 hotovost a cenné papíry za 3,9 miliardy USD.
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.
