Roivant Sciences Ltd. (ROIV) Discusses Phase 3 Results for Brepocitinib in Non-Infectious Uveitis October 21, 2026 8:00 AM EDT
Company Participants
Stephanie Lee Griffin - Chief Operating Officer of Roivant Platforms
Matthew Gline - CEO & Director
Benjamin Zimmer - Chief Executive Officer
Conference Call Participants
Yaron Werber - TD Cowen, Research Division
Lut Ming Cheng - JPMorgan Chase & Co, Research Division
Yasmeen Rahimi - Piper Sandler & Co., Research Division
Samantha Semenkow - Citigroup Inc., Research Division
Alexander Thompson - Stifel, Nicolaus & Company, Incorporated, Research Division
Yatin Suneja - Guggenheim Securities, LLC, Research Division
Prakhar Agrawal - Cantor Fitzgerald & Co., Research Division
Douglas Tsao - H.C. Wainwright & Co, LLC, Research Division
Jason Gerberry - BofA Securities, Research Division
Andy Chen - Wolfe Research, LLC
Presentation
Operator
Good day, and thank you for standing by. Welcome to the Roivant's CLARITY Phase III Study Results Conference Call. [Operator Instructions] Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Stephanie Lee. Please go ahead.
Stephanie Lee Griffin
Chief Operating Officer of Roivant Platforms
Good morning, and thanks for joining today's call to review the CLARITY Phase III results. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. For those dialing into your 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 them. I'd like to remind you that we will 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. And with that, I'll turn it over to Matt.
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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BASEL, Switzerland and LONDON and NEW YORK, Oct. 21, 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 Monday, November 9, 2026, to report its financial results for the second quarter ended September 30, 2026, and provide a business update.
Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in NIUMedian time to treatment failure for brepocitinib patients was greater than 48 weeks in both studies, compared with ~12 weeks on placebo in each study (p<0.0001 in both studies), including 40 weeks of steroid-free treatment, setting a new bar for time to failure and steroid-sparing benefit in NIUPooled across the CLARITY studies, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with 20% on placebo (p<0.0001), with similar results in each studyOf patients that entered the CLARITY studies (pooled) with macular edema, 42% of eyes on brepocitinib achieved resolution of macular edema at Week 48, compared with 4.8% on placebo (p<0.0001), with similar results in each studyThe magnitude and breadth of benefit observed across every ranked endpoint, compared with results reported in registrational trials of existing NIU therapies, suggest brepocitinib has the potential to be the most effective systemic, non-steroid treatment option for NIUSafety data consistent with prior brepocitinib clinical trials; no new safety signals or findingsPriovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for the treatment of NIU in the first half of calendar year 2027Roivant will host an investor call to discuss these updates today, October 21, 2026, at 8:00 a.m. ET BASEL, Switzerland and LONDON and NEW YORK and DURHAM, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq:ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (NIU). Brepocitinib met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies. Brepocitinib also achieved statistically significant and clinically meaningful benefit on all key secondary endpoints, including measurements of sustained steroid-free quiescence at Week 48, chorioretinal vascular leakage, resolution of macular edema and patient-reported visual functioning. These results were achieved despite a substantially more aggressive steroid taper than precedent NIU trials.
“Today marks a potential turning point for the field of uveitis and for the patients and physicians who have waited nearly a decade for a new systemic, non-steroid treatment option. The phenomenal results from the Phase 3 CLARITY program suggest that brepocitinib could meaningfully change how we treat non-infectious uveitis across multiple etiologies,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Professor of Medicine (Immunology/Rheumatology), and Professor of Pediatrics (Rheumatology) at the Byers Eye Institute and Stanford University School of Medicine, President of the International Ocular Inflammation Society (IOIS), and Executive Vice President of the Foster Ocular Immunology Society (FOIS). “Even with a much faster taper of oral prednisone, patients treated with brepocitinib in CLARITY demonstrated highly differentiated benefits across the primary and all key secondary endpoints, including quiescence, resolution of macular edema and improvement in chorioretinal inflammation. This is the kind of outcome that can redefine expectations for an entire field. To see this breadth of benefit across disease control, macular edema and visual functioning is tremendously exciting for those of us who care for these patients.”
NIU, a debilitating ocular inflammation, is one of the leading causes of blindness among the working age population. Undertreated NIU can result in permanent vision loss. NIU is frequently associated with ocular pain, floaters and visual impairment across multiple domains (acuity, peripheral vision, color recognition, ability to focus on moving objects, night vision, etc.) that can interfere with everyday activities including reading the newspaper, driving, socializing, working and independent self-care. NIU is estimated to affect 70,000 to 190,000 adults in the United States.
CLARITY Study Design and Data
The CLARITY program enrolled 371 patients across two identical studies, CLARITY-1 and CLARITY-2. Patients were randomized 1:1 to once-daily brepocitinib 45 mg or placebo for a 48-week double-masked treatment period. All patients received an 8-week oral corticosteroid (OCS) regimen of 60 mg/day for 2 weeks followed by a mandatory 6-week steroid taper to zero. The primary endpoint was time to treatment failure, assessed from Week 6 through Week 48.
Time to treatment failure in CLARITY-1 and CLARITY-2 (Kaplan-Meier estimates, brepocitinib vs. placebo) is captured below:
Brepocitinib demonstrated consistent benefits on preventing treatment failure across key subgroups, including intermediate, posterior, and panuveitis; patients with and without prior TNFi experience; and multiple etiologies of uveitis, including idiopathic disease, birdshot chorioretinopathy, and sarcoidosis.
Pre-specified multiplicity controlled secondary endpoints in the CLARITY trials included sustained steroid-free quiescence, improvement in chorioretinal vascular leakage as assessed through wide-field fluorescein angiography (FA), resolution of macular edema, and improvement in patient-reported visual functioning (NEI VFQ-25 overall composite score).
Results on the primary and key secondary endpoints are captured below:
CLARITY-1 (N=166)CLARITY-2 (N=204) Brepocitinib
45 mgPlaceboDelta*Brepocitinib
45 mgPlaceboDelta*Hazard Ratio for Treatment Failure vs. Placebo (95% CI)0.27
(0.17–0.43)-- P<0.00010.22
(0.14–0.34)-- P<0.0001Cumulative Incidence of Treatment Failure at Week 4835.4% 78.7% Δ 43.3%; P<0.000132.4% 77.8% Δ 45.4%; P<0.0001Steroid-Free Quiescence in Both Eyes at Week 4858.8% 19.8% Δ 38.1%; P<0.000164.4% 19.4% Δ 45.2%; P<0.0001Achievement of FA Response (≥ 30% Reduction from Baseline) at Week 48 Among Eyes With FA Score > 5 at Baseline39.4% 8.6% Δ 31.3%; P<0.000154.9% 7.2% Δ 49.8%; P<0.0001Resolution of Macular Edema at Week 48 Among Eyes with Macular Edema at Baseline40.4% 2.1% Δ 33.3%; P=0.004142.6% 7.0% Δ 40.1%; P=0.0002Achievement of ≥ 5-point Improvement in NEI VFQ-25 Overall Composite Score from Baseline at Week 48, Among Subjects with Baseline ≤ 9536.4% 13.7% Δ 21.9%; P=0.001340.4% 14.1% Δ 24.5%; P=0.0003 *Deltas account for covariates
Efficacy analyses exclude one subject who was randomized but did not receive any doses of masked study drug.
Safety and Regulatory Submissions
Brepocitinib was generally well tolerated during the treatment period. Most events were mild or moderate in severity, and only 3% of participants discontinued treatment due to an AE. The observed safety profile in the trials was consistent with the known safety profile of brepocitinib, with no new safety signals observed.
Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for treatment of NIU in the first half of calendar year 2027.
“The breadth and magnitude of benefit seen in the CLARITY studies position brepocitinib to potentially set a new standard for the treatment of non-infectious uveitis,” said Ben Zimmer, CEO of Priovant. “With LISRAYA now commercially available for adults with dermatomyositis, we see NIU as the potential next pillar of a leading rare disease immunology franchise. I would like to thank all of the investigators and patients who participated in the CLARITY trials, without whom this moment would not be possible.”
Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, October 21, 2026, to discuss the Phase 3 results for brepocitinib in non-infectious uveitis. 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.
Roivant will also host an investor day on Wednesday, December 9, 2026. To attend the event in person or by webcast, please register online using this registration link.
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. See important LISRAYA safety information, including boxed warning, at lisrayahcp.com/pi. Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, also recently generated positive Phase 3 data in non-infectious uveitis (NIU). Brepocitinib is under evaluation in a Phase 3 program in cutaneous sarcoidosis, and a Phase 2b/3 program in lichen planopilaris. These potential indications have not been approved by the FDA. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.
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.
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, the timing of potential regulatory approvals for our product and product candidates, 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.
Assenagon Asset Management S.A. lessened its holdings in shares of Roivant Sciences Ltd. (NASDAQ:ROIV – Free Report) by 11.7% during the 3rd quarter, according to its most recent filing with the Securities and Exchange Commission. The firm owned 7,382,971 shares of the company’s stock after selling 979,981 shares during the quarter. Assenagon Asset Management S.A. owned 1.02% of Roivant Sciences worth $269,995,000 as of its most recent SEC filing.
Other hedge funds and other institutional investors have also recently added to or reduced their stakes in the company. Perceptive Advisors LLC grew its stake in Roivant Sciences by 3.8% in the first quarter. Perceptive Advisors LLC now owns 8,285,461 shares of the company’s stock valued at $229,507,000 after acquiring an additional 300,000 shares during the period. Baker BROS. Advisors LP increased its holdings in shares of Roivant Sciences by 47.4% in the fourth quarter. Baker BROS. Advisors LP now owns 5,555,017 shares of the company’s stock worth $120,544,000 after acquiring an additional 1,787,244 shares in the last quarter. Wellington Management Group LLP raised its position in shares of Roivant Sciences by 179.0% during the second quarter. Wellington Management Group LLP now owns 2,687,870 shares of the company’s stock worth $95,124,000 after purchasing an additional 1,724,588 shares during the period. Bank of America Corp DE raised its position in shares of Roivant Sciences by 8.0% during the first quarter. Bank of America Corp DE now owns 3,163,821 shares of the company’s stock worth $87,638,000 after purchasing an additional 235,493 shares during the period. Finally, Janus Henderson Group PLC raised its position in shares of Roivant Sciences by 6.1% during the first quarter. Janus Henderson Group PLC now owns 3,095,448 shares of the company’s stock worth $85,790,000 after purchasing an additional 177,339 shares during the period. 64.76% of the stock is currently owned by institutional investors.
Wall Street Analyst Weigh In Several brokerages recently issued reports on ROIV. TD Cowen boosted their price objective on Roivant Sciences from $50.00 to $55.00 and gave the company a “buy” rating in a research report on Wednesday, September 9th. Sanford C. Bernstein raised Roivant Sciences to a “strong-buy” rating in a research note on Wednesday, July 29th. Jefferies Financial Group raised their target price on shares of Roivant Sciences from $42.00 to $52.00 and gave the stock a “buy” rating in a report on Tuesday, September 8th. UBS Group set a $55.00 target price on shares of Roivant Sciences in a report on Wednesday, September 9th. Finally, Cantor Fitzgerald reaffirmed an “overweight” rating on shares of Roivant Sciences in a research note on Thursday, September 24th. One research analyst has rated the stock with a Strong Buy rating, ten have assigned a Buy rating, two have assigned a Hold rating and one has given a Sell rating to the stock. According to MarketBeat.com, the stock presently has a consensus rating of “Moderate Buy” and an average target price of $45.64.
Check Out Our Latest Report on Roivant Sciences Insider Transactions at Roivant Sciences In other news, CEO Eric Venker sold 200,000 shares of the company’s stock in a transaction dated Wednesday, September 30th. The stock was sold at an average price of $36.62, for a total transaction of $7,324,000.00. Following the completion of the transaction, the chief executive officer directly owned 1,599,154 shares of the company’s stock, valued at $58,561,019.48. This represents a 11.12% decrease in their ownership of the stock. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available at this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Melissa Epperly sold 17,750 shares of the stock in a transaction dated Thursday, October 1st. The stock was sold at an average price of $36.10, for a total value of $640,775.00. Following the transaction, the director owned 14,954 shares of the company’s stock, valued at approximately $539,839.40. The trade was a 54.27% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders sold 1,622,688 shares of company stock valued at $58,826,636 over the last three months. Company insiders own 8.80% of the company’s stock.
Roivant Sciences Trading Up 1.2% Shares of NASDAQ ROIV opened at $34.04 on Friday. The firm has a market cap of $24.59 billion, a PE ratio of -64.23 and a beta of 1.10. Roivant Sciences Ltd. has a 1-year low of $16.88 and a 1-year high of $42.50. The company has a fifty day moving average price of $36.66 and a 200 day moving average price of $33.05.
Roivant Sciences (NASDAQ:ROIV – Get Free Report) last released its earnings results on Friday, August 7th. The company reported ($0.26) earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of ($0.30) by $0.04. Roivant Sciences had a negative return on equity of 22.94% and a negative net margin of 3,534.96%. The firm had revenue of $1.44 million during the quarter, compared to analysts’ expectations of $2.06 million. Equities research analysts forecast that Roivant Sciences Ltd. will post -2.00 EPS for the current year.
Roivant Sciences Profile (Free Report)
Roivant Sciences Ltd. (NASDAQ:ROIV) is a biopharmaceutical company focused on discovering, developing and commercializing medicines for patients with serious or underserved diseases. The company operates through a network of subsidiary companies, known as “Vants,” each dedicated to specific therapeutic areas, drug candidates or commercial opportunities.
Roivant’s research and development activities have included treatments for immune-mediated diseases, rare disorders, oncology and conditions affecting the nervous system.
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Janux Therapeutics (NASDAQ:JANX – Get Free Report) and Roivant Sciences (NASDAQ:ROIV – Get Free Report) are both healthcare companies, but which is the superior investment? We will compare the two businesses based on the strength of their earnings, risk, dividends, analyst recommendations, profitability, institutional ownership and valuation.
Volatility & Risk Janux Therapeutics has a beta of 2.4, meaning that its share price is 140% more volatile than the S&P 500. Comparatively, Roivant Sciences has a beta of 1.1, meaning that its share price is 10% more volatile than the S&P 500.
Valuation and Earnings This table compares Janux Therapeutics and Roivant Sciences”s top-line revenue, earnings per share (EPS) and valuation.
Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Janux Therapeutics $10.00 million 101.13 -$113.62 million ($1.64) -10.09 Roivant Sciences $8.26 million 3,128.89 -$299.77 million ($0.53) -67.51 Janux Therapeutics has higher revenue and earnings than Roivant Sciences. Roivant Sciences is trading at a lower price-to-earnings ratio than Janux Therapeutics, indicating that it is currently the more affordable of the two stocks.
Institutional and Insider Ownership 75.4% of Janux Therapeutics shares are held by institutional investors. Comparatively, 64.8% of Roivant Sciences shares are held by institutional investors. 7.9% of Janux Therapeutics shares are held by insiders. Comparatively, 8.8% of Roivant Sciences shares are held by insiders. Strong institutional ownership is an indication that hedge funds, endowments and large money managers believe a stock will outperform the market over the long term.
Profitability This table compares Janux Therapeutics and Roivant Sciences’ net margins, return on equity and return on assets.
Net Margins Return on Equity Return on Assets Janux Therapeutics N/A -11.89% -11.13% Roivant Sciences -3,534.96% -22.94% -21.53% Analyst Recommendations This is a breakdown of current ratings and target prices for Janux Therapeutics and Roivant Sciences, as reported by MarketBeat.com.
Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Janux Therapeutics 2 2 10 1 2.67 Roivant Sciences 1 1 10 1 2.85 Janux Therapeutics presently has a consensus target price of $36.46, indicating a potential upside of 120.44%. Roivant Sciences has a consensus target price of $45.64, indicating a potential upside of 27.55%. Given Janux Therapeutics’ higher possible upside, research analysts clearly believe Janux Therapeutics is more favorable than Roivant Sciences.
Summary Janux Therapeutics beats Roivant Sciences on 9 of the 13 factors compared between the two stocks.
(Get Free Report)
Janux Therapeutics, Inc., a clinical stage biopharmaceutical company, develops immunotherapies based on Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (TRACIr) platforms technology to treat patients suffering from cancer. The company's clinical candidates comprise JANX007, a prostate-specific membrane antigen or PSMA-TRACTr, which is in Phase 1 clinical trial in adults for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and the vasculature of other tumors; and JANX008, an epidermal growth factor receptor or EGFR-TRACTr that is in Phase 1 clinical trial for the treatment of multiple solid cancers, including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Its development pipeline also consists of discovery stage products. The company has strategic research collaboration agreement with Merck Sharp & Dohme Corp. to develop TRACTr product candidates. Janux Therapeutics, Inc. was incorporated in 2017 and is headquartered in San Diego, California.
About Roivant Sciences (Get Free Report)
Roivant Sciences Ltd., a commercial-stage biopharmaceutical company, engages in the development and commercialization of medicines for inflammation and immunology areas. The company provides Vants, a model to develop and commercialize its medicines and technologies focusing on biopharmaceutical businesses, discovery-stage companies, and health technology startups. It develops VTAMA, a novel topical for the treatment of psoriasis and atopic dermatitis; batoclimab and IMVT-1402, the fully human monoclonal antibodies targeting the neonatal Fc receptor across various IgG-mediated autoimmune indications; and RVT-3101, an anti-TL1A antibody for ulcerative colitis and Crohn's disease. The company was founded in 2014 and is based in London, the United Kingdom.
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What happened Roivant Sciences Ltd. (NASDAQ: ROIV) said Eric Venker, its president and Immunovant CEO, exercised options for 200,000 shares and sold 200,000 shares on 2026-09-30. The shares sold at a weighted average $36.62 each, within a reported range of $36.49 to $36.76, for about $7.32 million. The sales were effected in multiple transactions.
The filing says the option package was fully vested, with a $3.85 exercise price and 3,644,834 derivative shares beneficially owned following the reported transaction. After the exercise and sale, Venker held 1,599,154 shares. The form was signed on 2026-10-02, and the trades were made under a Rule 10b5-1 trading plan adopted on March 28, 2025.
Key numbers Metric Latest Change Source Shares sold 200,000 shares SEC Form 4 Weighted average sale price $36.62 per share SEC Form 4 Sale value $7.32 million SEC Form 4 Shares held after sale 1,599,154 shares SEC Form 4 Option exercise price $3.85 per share SEC Form 4 Read more: Roivant Sciences (ROIV) stock analysis and investment case Why it matters Venker's sale covered about 11.1% of the 1,799,154 shares held before the sale, so the transaction was sizable relative to that holding. The spread between the $3.85 exercise price and the $36.62 weighted average sale price shows the filing captures an exercise-and-sell sequence, not a simple cash purchase.
Venker still held 1,599,154 shares afterward, and the filing also shows 3,644,834 derivative shares beneficially owned following the reported transaction. That is why the common stake and the derivative position matter as context for this filing even though the report is still just one preplanned trade. OptimistFi's case is that Roivant's stock works only if its 'vant' model repeatedly turns clinical development assets into approvals, partnerships, or sales before cash burn erodes optionality.
This filing is mixed because it shows an insider sale, but the trade was tied to a fully vested option grant and a prearranged Rule 10b5-1 plan.
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What's next Roivant Sciences Ltd.'s next quarterly report is the next scheduled test of that case. A report with fresh progress on approvals, partnerships or sales would strengthen OptimistFi's case. A report that still leaves the platform waiting for those outcomes would keep the cash-burn and optionality questions at the center.
Until then, the filing leaves investors with Venker's preplanned trade and a reduced direct stake. The option exercise and sale do not change the next benchmark, which is whether Roivant can keep turning development work into business outcomes. That next report, not this Form 4, is the cleaner read on whether the investment case improves.
More from OptimistFi ROIV stock: the Roivant Sciences thesis, its status and the next test to watch Century Therapeutics, Inc. (NASDAQ: IPSC) Adds Two CNTY-813 Batches Applied Digital Corporation (NASDAQ: APLD) Brings 250 MW Online ON Semiconductor Corporation (NASDAQ: ON) Cuts Its Deal Cost by 19% Stock research on every company OptimistFi covers Latest stock research and investment-case updates OptimistFi: evidence-first equity research Sources SEC Form 4 — Form 4 for Eric Venker filed 2026-10-02 Read the full OptimistFi thesis on Roivant Sciences Ltd.: https://optimistfi.com/stocks/ROIV
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Originally published on OptimistFi, evidence-first equity research. More at optimistfi.com.
Roivant 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.
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.
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.
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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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.
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 DURHAM, N.C., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT) today announced topline results from Period 1 of its 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.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding Immunovant’s plans and progress towards developing IMVT-1402 across a broad range of indications. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, regulatory strategy, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 20, 2026, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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 Sciences Ltd. (NASDAQ:ROIV – Get Free Report) Director Melissa Epperly sold 4,938 shares of the stock in a transaction on Tuesday, September 15th. The shares were sold at an average price of $39.74, for a total value of $196,236.12. Following the completion of the transaction, the director owned 9,900 shares in the company, valued at $393,426. The trade was a 33.28% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the SEC, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.
Roivant Sciences Stock Performance NASDAQ ROIV opened at $39.77 on Friday. The stock has a market capitalization of $28.73 billion, a P/E ratio of -75.04 and a beta of 1.12. Roivant Sciences Ltd. has a 52 week low of $14.50 and a 52 week high of $42.50. The stock has a fifty day moving average of $36.18 and a 200-day moving average of $32.03.
Roivant Sciences (NASDAQ:ROIV – Get Free Report) last issued its quarterly earnings results on Friday, August 7th. The company reported ($0.26) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.30) by $0.04. The business had revenue of $1.44 million for the quarter, compared to analyst estimates of $2.06 million. Roivant Sciences had a negative return on equity of 22.94% and a negative net margin of 3,534.96%. Equities research analysts forecast that Roivant Sciences Ltd. will post -2 earnings per share for the current fiscal year.
Wall Street Analyst Weigh In ROIV has been the topic of several recent research reports. Jefferies Financial Group raised their target price on shares of Roivant Sciences from $42.00 to $52.00 and gave the company a “buy” rating in a research note on Tuesday, September 8th. HC Wainwright raised their price objective on shares of Roivant Sciences from $41.00 to $47.00 and gave the company a “buy” rating in a research note on Tuesday, September 8th. Cantor Fitzgerald reiterated an “overweight” rating on shares of Roivant Sciences in a research report on Tuesday, August 25th. Stifel Nicolaus started coverage on Roivant Sciences in a research note on Wednesday. They issued a “buy” rating and a $51.00 price target on the stock. Finally, Citigroup raised their price target on Roivant Sciences from $42.00 to $46.00 and gave the stock a “buy” rating in a research report on Monday, August 10th. One investment analyst has rated the stock with a Strong Buy rating, ten have issued a Buy rating, one has assigned a Hold rating and one has given a Sell rating to the company’s stock. According to data from MarketBeat.com, Roivant Sciences has a consensus rating of “Moderate Buy” and a consensus price target of $45.64. Get Our Latest Stock Report on Roivant Sciences
Institutional Inflows and Outflows A number of institutional investors have recently bought and sold shares of the company. Goldman Sachs Group Inc. raised its holdings in Roivant Sciences by 365.2% in the fourth quarter. Goldman Sachs Group Inc. now owns 10,982,633 shares of the company’s stock worth $238,323,000 after purchasing an additional 8,621,567 shares during the period. Assenagon Asset Management S.A. increased its position in shares of Roivant Sciences by 18.2% in the 2nd quarter. Assenagon Asset Management S.A. now owns 8,362,952 shares of the company’s stock valued at $295,965,000 after buying an additional 1,286,464 shares in the last quarter. Perceptive Advisors LLC increased its position in shares of Roivant Sciences by 3.8% in the 1st quarter. Perceptive Advisors LLC now owns 8,285,461 shares of the company’s stock valued at $229,507,000 after buying an additional 300,000 shares in the last quarter. Baker BROS. Advisors LP raised its stake in Roivant Sciences by 47.4% during the 4th quarter. Baker BROS. Advisors LP now owns 5,555,017 shares of the company’s stock worth $120,544,000 after buying an additional 1,787,244 shares during the period. Finally, Norges Bank bought a new position in Roivant Sciences during the fourth quarter worth about $112,750,000. Institutional investors and hedge funds own 64.76% of the company’s stock.
Roivant Sciences Company Profile (Get Free Report)
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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LISRAYA's recent approval gives ROIV a nice commercial foundation, while additional indications could turn brepocitinib into a broader immunology franchise. ROIV's pulmonary asset with mosliciguat is also promising. This candidate may be helpful for vascular resistance and walking distance improvements. I believe mosliciguat could over time become a valuable pulmonary franchise, but we still need to see how its subsequent Phase 3 plays out.
Roivant Sciences Ltd. (ROIV) Citigroup's Biopharma Back to School Summit 2026 September 10, 2026 10:00 AM EDT
Company Participants
Richard Pulik - Chief Financial Officer
Conference Call Participants
Samantha Lynn Semenkow - Citigroup Inc. Exchange Research
Presentation
Samantha Lynn Semenkow
Citigroup Inc. Exchange Research
Sam Semenkow, one of the senior biotech analysts here at Citi. And it is my pleasure to be hosting Roivant at Citi's 2026 Biopharma Back to School Summit. I'm joined by Richard Pulik, CFO of Roivant. Richard, welcome, and thank you so much for being here.
Richard Pulik
Chief Financial Officer
Thank you so much. And it's officially, I think, also the first day of school in New York School. So perfect timing with the conference.
Question-and-Answer Session
Samantha Lynn Semenkow
Citigroup Inc. Exchange Research
Yes, it is. It is, and we will go to school today on Roivant. So why don't we just start off high level, Richard. Obviously, you've made a lot of progress on the pipeline, lots of great data that you shared with us this year. And you've had your first FDA approval for brepocitinib. Maybe just level set all of that and what we can expect throughout the rest of the year, where Roivant stands and where Roivant aims to be in the next several years?
Richard Pulik
Chief Financial Officer
Look, we've had an incredible year so far. As we think about Roivant, look, we're approaching $30 billion market cap here. We have $3.9 billion in cash, which doesn't include the $700 million plus that we received in July on the Moderna settlement. And we have now, I would say, with the [ mosli ] data that read out a couple of days ago, really affirmed the third leg of the stool into a place where that can be another big pillar for the company, adding to brepocitinib, where you mentioned, just had our first approval for LISRAYA is the
Roivant Sciences Ltd. (ROIV) 12th Annual Cantor Fitzgerald Global Healthcare Conference September 9, 2026 1:00 PM EDT
Company Participants
Matthew Gline - CEO & Director
Conference Call Participants
Prakhar Agrawal - Cantor Fitzgerald & Co., Research Division
Presentation
Prakhar Agrawal
Cantor Fitzgerald & Co., Research Division
All right. Good day, everyone. Welcome to Day 1 of Cantor's Global Healthcare Conference. For the next session, we are very excited to host the Roivant team. And representing Roivant, we have CEO, Matt Gline. Matt, coming off the back of a very strong data set. Happy to host you here.
Matthew Gline
CEO & Director
Yes. Great. Thanks for having me. It's always easier to do these after putting out good data. So...
Question-and-Answer Session
Prakhar Agrawal
Cantor Fitzgerald & Co., Research Division
Great. So why don't we start there? Well, first of all, congrats to your clinical operations team. As well as your BD team, who got this asset from Bayer for, what, $15 million?
Matthew Gline
CEO & Director
About that. Yes, a little less.
Prakhar Agrawal
Cantor Fitzgerald & Co., Research Division
What's the secret sauce?
Matthew Gline
CEO & Director
I don't know the answer. And if I did, I couldn't tell you.
Prakhar Agrawal
Cantor Fitzgerald & Co., Research Division
Anyways, maybe focusing on mosli first, given it's hard off the press. What were some of the more surprising aspects of the data set now that you have had some time to digest?
Matthew Gline
CEO & Director
I had like 36 whole hours. Yes. So look, this -- for those that don't know, so mosli -- mosliciguat is a drug that we had in development. It is an inhaled SGC activator that we are developing in pulmonary hypertension. And it's a drug we got, as you mentioned, from Bayer, a few years ago. And I think what I said about this
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.
Read Next
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.
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.
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 significantPre-specified 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 prostacyclinsPhase 3 PHrontier study of mosliciguat in patients with PH-ILD has been initiated, with enrollment underwayResults 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 BASEL, Switzerland and LONDON and NEW YORK, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) 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.
“PH-ILD is a disease as bad as some forms of cancer, with a median survival of just 1.5-2 years despite best-available standard of care. We wanted to see if we could make an impact in this terrible disease when we brought mosliciguat into Roivant. Our thesis was that the ATMOS study actually understated the potential of mosliciguat – and when dosed chronically, it would do considerably more. These PHocus results proved that out as clearly as we could have hoped: a profound 56.3% placebo-adjusted PVR reduction – the largest PVR reported in any controlled pulmonary hypertension trial of any group," said Mayukh Sukhatme, President and Chief Investment Officer at Roivant. "This data set puts mosliciguat in a league of its own on PVR reduction, 6MWD improvement, NT-proBNP % reduction, cough rate, and ease of use. It is a terrific example of the Roivant model working as planned: finding high-potential molecules and going after diseases where the patient needs are enormous and where the drug can truly shine.”
“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 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.
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.
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.
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.
BASEL, Switzerland and LONDON and NEW YORK, Sept. 06, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) and Pulmovant 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. Roivant will also host an investor call and webcast at 8:00 a.m. ET on Tuesday, September 8, 2026.
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 www.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 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.
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.
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.
The U.S. Food and Drug Administration said on Thursday it approved a treatment from Roivant (ROIV.O) and partner Priovant Therapeutics for a rare disease, making it the first oral drug for the condition affecting skin and muscles.
Shares of Roivant closed up 2% at $37.58 in afternoon trading.
Branded as Lisraya, the drug was approved for dermatomyositis, a condition that causes painful skin rashes and progressive muscle weakness and, if untreated, can severely reduce quality of life.
"This moment represents a litany of firsts for dermatomyositis patients," Priovant CEO Ben Zimmer told Reuters, calling it the first oral treatment and the first to target immune pathways linked to the disease, with skin, muscle, physical function and steroid-sparing benefits.
Zimmer said the company will reveal pricing details for the drug through an investor call on Friday.
The companies said the drug improved both skin and muscle symptoms in a late-stage trial, reducing or stopping the need for steroids, which are commonly used but can cause long-term side effects.
In the trial, patients receiving a daily 30 mg dose of brepocitinib (Lisraya) 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.
"While dermatomyositis remains a relatively under-appreciated indication within inflammation and immunology, we view it as a highly attractive commercial opportunity for Roivant." said J.P.Morgan analyst Brian Cheng.
Cheng forecasts U.S. peak annual sales of more than $2 billion for Lisraya in dermatomyositis alone by the early 2030s.
Pfizer (PFE.N) in 2021 licensed brepocitinib to Priovant Therapeutics, a joint company it created with Roivant.
Octapharma's intravenous drug Octagam 10% is the only other modern, targeted therapy that is FDA-approved for the condition.
According to the National Institutes of Health, dermatomyositis affects fewer than 5,000 people in the U.S.
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.
Trump Index: 6 Companies Linked to Trump’s Cabinet Worth WatchingRoivant Sciences NASDAQ: ROIV said the U.S. Food and Drug Administration has approved LISRAYA, its once-daily oral therapy for adults with dermatomyositis, and that the drug has already entered commercial launch.
Matt Gline, Roivant’s CEO, called the approval a significant milestone for patients with dermatomyositis, a rare and heterogeneous inflammatory disease affecting skin, muscle and, in some cases, other organs. He said LISRAYA is the first targeted therapy approved for dermatomyositis, the first once-daily oral therapy approved for the condition, and the first treatment approved specifically with a steroid-sparing benefit in the disease.
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The therapy, brepocitinib, is a TYK2/JAK1 inhibitor. Gline said it is also the first TYK2/JAK1 inhibitor approved for any indication. He noted that prior efforts to advance therapies including rituximab, Remicade and Enbrel in dermatomyositis-specific studies had not succeeded.
Commercial Launch Begins Ben Zimmer, CEO of Priovant, said LISRAYA launched commercially on the same day as its approval, approximately one month ahead of the company’s initial plan. Prescribing is open, and Priovant has already received its first prescriptions, he said.
The drug carries a wholesale acquisition cost, or list price, of $35,000 for a 30-day supply. Gline estimated that the annual net value to the company for a patient receiving a full year of therapy could be in the low-to-mid-$300,000 range after accounting for compliance, gross-to-net adjustments and other factors. He cautioned that the estimate contains substantial uncertainty because LISRAYA is the first novel therapy to launch in this disease setting.
Priovant has established the My Compass Support program to assist patients with insurance navigation and financial assistance. Zimmer said the company expects many patients to have no out-of-pocket costs, while Gline said eligible patients could pay as little as $0 per month through copay support. The company is also using a limited network of specialty pharmacies intended to provide high-touch support for rare-disease patients.
Broad Label and Clinical Data Zimmer said the FDA label provides a broad indication for adults with dermatomyositis, without restrictions based on clinical presentation, disease severity or prior treatment history. The label also does not restrict concomitant use with steroids, conventional synthetic disease-modifying antirheumatic drugs, or intravenous immunoglobulin, or IVIG.
According to Zimmer, the label includes efficacy information supporting improvements in skin disease, muscle strength, physical function and overall disease burden, as well as patient-reported and physician-reported outcomes. The company highlighted LISRAYA’s steroid-sparing findings, including reductions in steroid use compared with placebo and measures of the ability to improve disease while reducing steroid dependence.
The approval was supported by the Phase III VALOR study, which Gline described as the largest placebo-controlled Phase III trial conducted in dermatomyositis. He said the study met its primary endpoint and every ranked secondary endpoint. VALOR data were published in The New England Journal of Medicine, while skin-specific secondary endpoint results were recently published in JAMA Dermatology.
Nearly 70% of patients receiving LISRAYA achieved a moderate response on the Total Improvement Score, or TIS, according to the company. Nearly 50% achieved a major response. Among patients starting on at least 7.5 milligrams per day of steroids, nearly two-thirds reduced steroid use to 2.5 milligrams or less, while nearly half discontinued steroids altogether by the end of the study. Zimmer said treatment discontinuations due to adverse events occurred at nearly twice the rate in the placebo group as in the LISRAYA group in VALOR. The drug’s label includes safety warnings associated with the JAK inhibitor class, which Zimmer said were expected and consistent with other approved JAK inhibitors.
During the call, management said there was one additional thrombosis case in the open-label extension period and no on-treatment malignancies in that period. Zimmer said the company plans to disclose the full efficacy and safety results from the extension study later.
Management Expects “Slow and Steady” Uptake Despite physician interest and the absence of an approved targeted competitor in dermatomyositis, Roivant repeatedly characterized its expected launch trajectory as “slow and steady.” Gline said treatment practices have remained largely unchanged for decades and that changing prescribing behavior, payer processes and access patterns will take time.
Management said it has engaged with payers and expects to help patients manage prior authorizations and reimbursement requirements, but it did not provide projections for coverage levels, prescription-to-reimbursement timing or early sales. Gline said quarterly net sales would ultimately be the most useful measure of launch performance, while noting that data from orphan-drug launches can be difficult to track through third-party prescription services.
The company said it has a commercial team in place and plans to expand its field force over time. About half of dermatomyositis patients are treated at 200 specialty referral centers, according to Gline.
Further Development Plans Roivant plans to pursue additional indications for LISRAYA. Gline said data in non-infectious uveitis are expected soon, while registrational programs in cutaneous sarcoidosis and lichen planopilaris are ongoing. He also referenced expected data from Roivant’s pulmonary hypertension program, IMVT-1402 in cutaneous lupus erythematosus, and additional rheumatoid arthritis updates before year-end.
“Dermatomyositis is just the beginning for brepocitinib,” Gline said, describing the approval as the start of a broader effort to build the LISRAYA franchise across multiple indications.
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 is transitioning from an asset-monetization platform to a commercial-stage biopharma, supported by a strong cash position and imminent product launches. ROIV's $4.7 billion pro forma liquidity eliminates near-term dilution risk, enabling commercialization of brepocitinib and continued pipeline investment without adverse equity market reliance. Brepocitinib's FDA Priority Review for dermatomyositis, with potential approval by September 2026, anchors near-term upside, while label expansions target a >280,000 patient opportunity.
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.
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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.
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.
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.
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.
All IMVT-1402 clinical development timelines remain on track, including ongoing studies in Graves' disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA), Sjögren's disease (SjD) and cutaneous lupus erythematosus (CLE) Current cash balance provides runway to the potential launch of IMVT-1402 in GD Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026 DURHAM, N.C.
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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Allspring Global Investments Holdings LLC purchased a new stake in Roivant Sciences Ltd. (NASDAQ:ROIV – Free Report) in the 1st quarter, according to its most recent filing with the SEC. The institutional investor purchased 142,134 shares of the company’s stock, valued at approximately $3,957,000.
Other hedge funds also recently added to or reduced their stakes in the company. Morgan Stanley boosted its position in shares of Roivant Sciences by 31.7% in the fourth quarter. Morgan Stanley now owns 58,359,553 shares of the company’s stock worth $1,266,402,000 after buying an additional 14,036,696 shares during the period. Vanguard Group Inc. grew its stake in shares of Roivant Sciences by 8.4% in the fourth quarter. Vanguard Group Inc. now owns 42,059,041 shares of the company’s stock valued at $912,681,000 after buying an additional 3,254,113 shares in the last quarter. Rubric Capital Management LP raised its holdings in shares of Roivant Sciences by 14.7% during the 2nd quarter. Rubric Capital Management LP now owns 20,370,336 shares of the company’s stock valued at $229,574,000 after buying an additional 2,603,260 shares during the period. State Street Corp raised its holdings in shares of Roivant Sciences by 4.8% during the 2nd quarter. State Street Corp now owns 19,773,480 shares of the company’s stock valued at $222,847,000 after buying an additional 911,827 shares during the period. Finally, UBS Group AG lifted its position in Roivant Sciences by 570.0% during the 4th quarter. UBS Group AG now owns 18,390,792 shares of the company’s stock worth $399,080,000 after acquiring an additional 15,645,836 shares in the last quarter. 64.76% of the stock is owned by hedge funds and other institutional investors.
Insider Buying and Selling In other Roivant Sciences news, Director Melissa B. Epperly sold 17,750 shares of the firm’s stock in a transaction that occurred on Monday, June 29th. The shares were sold at an average price of $34.38, for a total value of $610,245.00. Following the sale, the director owned 16,474 shares in the company, valued at approximately $566,376.12. This trade represents a 51.86% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which can be accessed through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Daniel Allen Gold sold 12,380 shares of the firm’s stock in a transaction that occurred on Tuesday, June 30th. The shares were sold at an average price of $35.28, for a total value of $436,766.40. Following the completion of the sale, the director owned 13,689,166 shares in the company, valued at approximately $482,953,776.48. This represents a 0.09% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. Insiders have sold a total of 1,855,913 shares of company stock valued at $62,649,633 in the last quarter. Company insiders own 10.80% of the company’s stock.
Analyst Upgrades and Downgrades Several brokerages have issued reports on ROIV. Guggenheim increased their price objective on shares of Roivant Sciences from $30.00 to $36.00 and gave the company a “buy” rating in a research report on Tuesday, May 26th. Leerink Partners set a $42.00 target price on shares of Roivant Sciences in a research note on Thursday, May 21st. TD Cowen raised their price target on shares of Roivant Sciences from $38.00 to $41.00 and gave the company a “buy” rating in a report on Thursday, May 21st. Citigroup lifted their price target on shares of Roivant Sciences from $35.00 to $42.00 and gave the stock a “buy” rating in a research note 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 assigned a Sell rating to the company’s stock. According to data from MarketBeat, the stock has an average rating of “Moderate Buy” and an average target price of $33.59.
Read Our Latest Stock Analysis on ROIV
Roivant Sciences Trading Down 0.3% Shares of NASDAQ ROIV opened at $35.01 on Friday. Roivant Sciences Ltd. has a 12-month low of $10.90 and a 12-month high of $37.00. The company has a market cap of $25.18 billion, a price-to-earnings ratio of -58.35 and a beta of 1.11. The stock’s 50 day simple moving average is $32.24 and its 200 day simple moving average is $28.62.
Roivant Sciences Company 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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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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DURHAM, N.C., July 23, 2026 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT) today announced that it will report its financial results for the first quarter ended June 30, 2026 on Thursday, August 6, 2026 before the market opens.
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.
The pharmaceutical industry is massive, worth over $1.7 trillion globally in 2024. So when an up-and-coming player emerges, it can deliver life-changing returns for investors fortunate enough to get in early. Roivant Sciences (ROIV +0.74%) certainly seems like a rising star. The biotech stock has more than tripled over the past year, soaring to $35 per share and a market cap of $25 billion.
Roivant is a biotech company turning a loaded pipeline into reality, and its sales could soar into the billions of dollars over the next five years. But can the stock continue to deliver multibagger returns? That won't be as easy after its recent ascension. Here's some math to consider when setting expectations for the stock.
Image source: Getty Images
A loaded pipeline with big things ahead Roivant Sciences builds small, focused subsidiaries called Vants that develop drug products and technologies to treat various diseases and health conditions. Across these Vants, Roivant has amassed an impressive pipeline that management expects will have three commercial launches over the next three years. Its lead drug candidate is brepocitinib, an oral drug for treating dermatomyositis, a chronic inflammatory disease affecting the skin and muscles.
The company has only generated $8.3 million in revenue over the past 12 months, but that's about to change in a big way. Wall Street estimates compiled by market intelligence company Fintel peg 2027 revenue at approximately $1 billion, rising to $4.5 billion in 2031. Now, those estimates assume that drug approvals go as planned, which isn't a certainty by any means. Still, the market expects enormous growth from Roivant Sciences, which helps explain the stock's recent rise.
Why buying now could be an uphill battle You may have heard the expression that the price you pay matters, but it rings truest in these situations.
Today's Change
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0.74
%) $
0.26
Current Price
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35.39
If you assume that Roivant does, in fact, reach $4.5 billion in sales in 2031, the stock, at a $25 billion market cap, already trades at 5.6 times those sales. A healthcare industry leader such as AbbVie trades at about 7 times its trailing-12-month sales, never mind revenue five years out.
If you buy Roivant Sciences now, you're assuming a lot of things go right over the coming years. Expectations can change, or better or worse, with a single clinical-trial readout.
But you need even more from Roivant if you're buying the stock as a potential multibagger over the next five years -- from here, that would mean the stock needs to reach a market cap of at least $50 billion to $75 billion. Is that possible? Of course. Is it likely? Probably not.
Justin Pope has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends AbbVie. The Motley Fool recommends Roivant Sciences. The Motley Fool has a disclosure policy.
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.
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.
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Capricorn Fund Managers Ltd raised its stake in Roivant Sciences Ltd. (NASDAQ:ROIV – Free Report) by 124.4% during the 4th quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission. The firm owned 445,500 shares of the company’s stock after buying an additional 247,000 shares during the quarter. Roivant Sciences accounts for about 2.3% of Capricorn Fund Managers Ltd’s portfolio, making the stock its 11th largest position. Capricorn Fund Managers Ltd owned approximately 0.06% of Roivant Sciences worth $9,667,000 as of its most recent filing with the Securities and Exchange Commission.
Other institutional investors also recently modified their holdings of the company. Jones Financial Companies Lllp raised its position in shares of Roivant Sciences by 226.0% in the 3rd quarter. Jones Financial Companies Lllp now owns 1,656 shares of the company’s stock valued at $25,000 after acquiring an additional 1,148 shares during the period. Allworth Financial LP grew its holdings in Roivant Sciences by 48.1% during the third quarter. Allworth Financial LP now owns 1,795 shares of the company’s stock valued at $27,000 after purchasing an additional 583 shares during the period. Bessemer Group Inc. grew its holdings in Roivant Sciences by 41.5% during the third quarter. Bessemer Group Inc. now owns 1,852 shares of the company’s stock valued at $28,000 after purchasing an additional 543 shares during the period. Osaic Holdings Inc. increased its stake in Roivant Sciences by 204.2% in the second quarter. Osaic Holdings Inc. now owns 5,783 shares of the company’s stock valued at $65,000 after purchasing an additional 3,882 shares in the last quarter. Finally, Aster Capital Management DIFC Ltd increased its stake in Roivant Sciences by 75.8% in the third quarter. Aster Capital Management DIFC Ltd now owns 4,405 shares of the company’s stock valued at $67,000 after purchasing an additional 1,900 shares in the last quarter. 64.76% of the stock is currently owned by institutional investors and hedge funds.
Analysts Set New Price Targets A number of equities analysts have recently weighed in on the stock. Citigroup lifted their price target on shares of Roivant Sciences from $26.00 to $35.00 and gave the stock a “buy” rating in a research report on Tuesday, February 10th. Sanford C. Bernstein assumed coverage on Roivant Sciences in a research note on Friday, March 20th. They set an “outperform” rating and a $35.00 price objective on the stock. Guggenheim lifted their target price on Roivant Sciences from $28.00 to $30.00 and gave the stock a “buy” rating in a report on Monday, February 9th. Jefferies Financial Group reissued a “buy” rating on shares of Roivant Sciences in a research note on Tuesday, March 3rd. Finally, The Goldman Sachs Group increased their price target on Roivant Sciences from $24.00 to $33.00 and gave the stock a “buy” rating in a report on Monday, December 15th. Nine investment analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has assigned a Sell rating to the stock. According to data from MarketBeat, the company has a consensus rating of “Moderate Buy” and an average target price of $29.50.
Get Our Latest Report on ROIV
Roivant Sciences Price Performance Roivant Sciences stock opened at $28.33 on Monday. The company has a 50 day moving average of $26.80 and a 200-day moving average of $22.28. Roivant Sciences Ltd. has a twelve month low of $8.73 and a twelve month high of $30.33. The stock has a market capitalization of $20.28 billion, a PE ratio of -24.21 and a beta of 1.20.
Insider Transactions at Roivant Sciences In other news, Director Daniel Allen Gold sold 425,000 shares of the business’s stock in a transaction dated Wednesday, February 11th. The stock was sold at an average price of $26.67, for a total value of $11,334,750.00. Following the sale, the director directly owned 15,928,113 shares in the company, valued at $424,802,773.71. The trade was a 2.60% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which is available at the SEC website. Also, Director Melissa B. Epperly sold 41,861 shares of the company’s stock in a transaction dated Monday, March 16th. The stock was sold at an average price of $28.68, for a total value of $1,200,573.48. Following the transaction, the director directly owned 15,804 shares of the company’s stock, valued at $453,258.72. This represents a 72.59% decrease in their ownership of the stock. The disclosure for this sale is available in the SEC filing. In the last 90 days, insiders sold 4,782,086 shares of company stock worth $128,848,063. Company insiders own 10.80% 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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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.
The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.
Individual investors often find it hard to make decisions based on rating upgrades by Wall Street analysts, since these are mostly driven by subjective factors that are hard to see and measure in real time. In these situations, the Zacks rating system comes in handy because of the power of a changing earnings picture in determining near-term stock price movements.
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.
Most Powerful Force Impacting Stock PricesThe change in a company's future earnings potential, as reflected in earnings estimate revisions, has proven to be strongly correlated with the near-term price movement of its stock. That's partly because of the influence of institutional investors that use earnings and earnings estimates for calculating the fair value of a company's shares. An increase or decrease in earnings estimates in their valuation models simply results in higher or lower fair value for a stock, and institutional investors typically buy or sell it. Their bulk investment action then leads to price movement for the stock.
For Montes Archimedes Acquisition, rising earnings estimates and the consequent rating upgrade fundamentally mean an improvement in the company's underlying business. And investors' appreciation of this improving business trend should push the stock higher.
Harnessing the Power of Earnings Estimate RevisionsEmpirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock movements, so it could be truly rewarding if such revisions are tracked for making an investment decision. Here is where the tried-and-tested Zacks Rank stock-rating system plays an important role, as it effectively harnesses the power of earnings estimate revisions.
The Zacks Rank stock-rating system, which uses four factors related to earnings estimates to classify stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record, with Zacks Rank #1 stocks generating an average annual return of +25% since 1988. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here >>>> .
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.
You can learn more about the Zacks Rank here >>>
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.
Elevate Capital Advisors LLC cut its stake in shares of Roivant Sciences Ltd. (NASDAQ:ROIV – Free Report) by 31.8% during the 4th quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The fund owned 77,545 shares of the company’s stock after selling 36,236 shares during the quarter. Elevate Capital Advisors LLC’s holdings in Roivant Sciences were worth $1,683,000 as of its most recent filing with the Securities and Exchange Commission.
Several other hedge funds and other institutional investors also recently made changes to their positions in ROIV. Assenagon Asset Management S.A. grew its holdings in shares of Roivant Sciences by 11,507.5% during the 4th quarter. Assenagon Asset Management S.A. now owns 6,937,112 shares of the company’s stock valued at $150,535,000 after purchasing an additional 6,877,348 shares during the last quarter. Perceptive Advisors LLC bought a new stake in shares of Roivant Sciences during the 2nd quarter valued at approximately $37,546,000. Marshall Wace LLP grew its holdings in shares of Roivant Sciences by 316.5% during the 3rd quarter. Marshall Wace LLP now owns 3,978,001 shares of the company’s stock valued at $60,187,000 after purchasing an additional 3,022,851 shares during the last quarter. Orbimed Advisors LLC bought a new stake in shares of Roivant Sciences during the 2nd quarter valued at approximately $31,324,000. Finally, Rubric Capital Management LP grew its holdings in shares of Roivant Sciences by 14.7% during the 2nd quarter. Rubric Capital Management LP now owns 20,370,336 shares of the company’s stock valued at $229,574,000 after purchasing an additional 2,603,260 shares during the last quarter. 64.76% of the stock is owned by institutional investors.
Analyst Ratings Changes Several equities research analysts recently issued reports on the stock. Citigroup lifted their price target on shares of Roivant Sciences from $26.00 to $35.00 and gave the company a “buy” rating in a report on Tuesday, February 10th. Sanford C. Bernstein initiated coverage on shares of Roivant Sciences in a report on Friday, March 20th. They set an “outperform” rating and a $35.00 target price on the stock. Guggenheim boosted their target price on shares of Roivant Sciences from $28.00 to $30.00 and gave the stock a “buy” rating in a report on Monday, February 9th. Leerink Partners boosted their target price on shares of Roivant Sciences from $29.00 to $32.00 and gave the stock an “outperform” rating in a report on Monday, December 15th. Finally, Weiss Ratings lowered shares of Roivant Sciences from a “hold (c-)” rating to a “sell (d)” rating in a report on Monday, February 9th. Nine research analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has issued a Sell rating to the stock. Based on data from MarketBeat.com, the stock currently has a consensus rating of “Moderate Buy” and an average price target of $29.50.
View Our Latest Stock Report on Roivant Sciences
Insider Activity In other news, insider Frank Torti sold 587,390 shares of the business’s stock in a transaction that occurred on Monday, February 23rd. The shares were sold at an average price of $27.51, for a total value of $16,159,098.90. Following the transaction, the insider owned 13,736,547 shares in the company, valued at approximately $377,892,407.97. The trade was a 4.10% decrease in their position. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through this link. Also, CAO Jennifer Humes sold 13,538 shares of the business’s stock in a transaction that occurred on Wednesday, April 8th. The stock was sold at an average price of $28.37, for a total transaction of $384,073.06. Following the completion of the transaction, the chief accounting officer owned 84,191 shares in the company, valued at $2,388,498.67. This trade represents a 13.85% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. Over the last ninety days, insiders sold 4,795,624 shares of company stock worth $129,232,136. Company insiders own 10.80% of the company’s stock.
Roivant Sciences Price Performance ROIV opened at $28.21 on Friday. Roivant Sciences Ltd. has a fifty-two week low of $9.57 and a fifty-two week high of $30.33. The firm has a market capitalization of $20.19 billion, a price-to-earnings ratio of -24.11 and a beta of 1.20. The company’s 50 day moving average price is $27.40 and its two-hundred day moving average price is $22.69.
Roivant Sciences Company 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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