brepocitinib

Search documents
Roivant Sciences (NASDAQ:ROIV) Stock Update and Phase 3 VALOR Study Results
Financial Modeling Prep· 2025-09-18 19:00
Company Overview - Roivant Sciences (NASDAQ:ROIV) is a biopharmaceutical company focused on developing transformative medicines [1] - The company has a market capitalization of approximately $10.23 billion [5] Stock Performance - On September 18, 2025, Citigroup adjusted its rating for Roivant to Neutral, maintaining a hold action, with the stock price at $15.47 [1] - Bank of America raised its price target for Roivant from $12 to $16.50 [1] - Currently, ROIV's stock price is $14.99, reflecting a decrease of approximately 1.93% or $0.30 [4] - Over the past year, ROIV has reached a high of $16.05 and a low of $8.73 [5] - Today's trading volume for ROIV is 2,323,718 shares, indicating active investor interest [5] Clinical Study Results - Roivant announced positive results from its Phase 3 VALOR study, which evaluated brepocitinib for treating dermatomyositis (DM) [2][6] - The study showed that a 30 mg daily dose of brepocitinib led to significant improvements compared to a placebo, achieving a week 52 mean Total Improvement Score (TIS) of 46.5 versus 31.2 for the placebo group [3] - The p-value of 0.0006 indicates strong statistical significance, with more than two-thirds of patients on the 30 mg dose experiencing at least a moderate response, and nearly half achieving a major response [3] Future Plans - Roivant plans to file a New Drug Application (NDA) in the first half of 2026, following the consistent safety profile of brepocitinib [4][6] - The company will also host an investor call to discuss the findings from the VALOR study [4]
Montes Archimedes Acquisition (ROIV) Surges 7.8%: Is This an Indication of Further Gains?
ZACKS· 2025-09-18 15:36
Company Overview - Roivant Sciences Ltd. (ROIV) shares increased by 7.8% to $15.28 in the last trading session, with a notable trading volume, and have gained 20.6% over the past four weeks [1][2] Clinical Development - Roivant, in partnership with Priovant Therapeutics, announced that their investigational candidate brepocitinib met the primary and all nine key secondary endpoints with statistical significance in the phase III VALOR study for dermatomyositis (DM) [2] - Brepocitinib demonstrated rapid, durable, and broad improvements in skin and muscle disease, along with a safety profile consistent with prior studies, marking a significant milestone as the first positive outcome for a 52-week placebo-controlled study in DM [2] Financial Expectations - The company is projected to report a quarterly loss of $0.26 per share, reflecting a year-over-year change of +10.3%, with expected revenues of $6.24 million, up 39.5% from the previous year [3] - Trends in earnings estimate revisions are correlated with near-term stock price movements, indicating potential strength in ROIV's stock [3][4] Industry Context - Montes Archimedes Acquisition, part of the same industry as Roivant, has seen its consensus EPS estimate remain unchanged, suggesting that stock price movements may not continue without earnings estimate trends [4] - ADC Therapeutics SA, another company in the biomedical and genetics industry, has a consensus EPS estimate of -$0.37, representing a year-over-year change of +11.9% [5]
Roivant/Priovant's Experimental Drug Shows Promise In Rare Skin Disease Trial
Benzinga· 2025-09-17 16:13
Core Insights - Roivant Sciences Ltd and Priovant Therapeutics announced positive results from the Phase 3 VALOR study for brepocitinib in treating dermatomyositis, marking a significant advancement in targeted therapy for this chronic autoimmune disorder [1][4]. Group 1: Study Results - Brepocitinib 30 mg showed a statistically significant improvement on the primary endpoint with a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006) [2][3]. - The treatment demonstrated clinically meaningful improvements across all nine key secondary endpoints, including skin and muscle disease metrics, steroid-sparing effects, and rapidity of onset [2][4]. Group 2: Patient Background and Outcomes - Approximately 75% of patients in the VALOR study were on background steroids, with a mean baseline dose of 12.2 mg/day in the brepocitinib group and 11.3 mg/day in the placebo group [5]. - Among those on steroids, 62% of brepocitinib patients reduced their steroid dose to ≤2.5 mg/day by the end of the study, compared to 34% for placebo, and 42% of brepocitinib patients were able to discontinue steroids entirely, versus 23% for placebo [5]. Group 3: Safety and Future Plans - The safety profile of brepocitinib 30 mg was consistent with previous clinical trials, indicating a favorable safety outcome [6]. - Priovant plans to file a New Drug Application (NDA) for brepocitinib in dermatomyositis in the first half of 2026 [6].
Lyft, Oruka Therapeutics, Roivant Sciences, Workday And Other Big Stocks Moving Higher On Wednesday - Robo.ai (NASDAQ:AIIO), Blue Gold (NASDAQ:BGL)
Benzinga· 2025-09-17 14:12
Group 1: Stock Market Overview - U.S. stocks exhibited mixed performance, with the Dow Jones index increasing by over 200 points on Wednesday [1] Group 2: Notable Stock Movements - Lyft, Inc. shares surged by 13.5% to $22.92 following the announcement of an expansion plan with Waymo to Nashville, where Lyft's Flexdrive will manage Waymo's fully autonomous vehicles [1] - New Fortress Energy Inc. saw its shares jump 32.3% to $2.6501 after securing a long-term gas supply agreement with the Puerto Rican government [3] - Oruka Therapeutics, Inc. experienced a 14.1% increase in shares to $17.01 after announcing interim Phase 1 results for ORKA-001 and a $180 million private placement [3] - Robo.ai Inc. shares rose by 12.9% to $1.9190 [3] - Roivant Sciences Ltd. gained 12% to $15.89 after reporting Phase 3 results for brepocitinib in treating a debilitating skin-muscle disease [3] - Opendoor Technologies Inc. shares surged by 11.1% to $9.91 [3] - Gevo, Inc. also gained 11.1%, reaching $2.1089 [3] - Blue Gold Limited saw a 10.5% increase to $11.05 [3] - Workday, Inc. shares surged by 9% to $238.63 after an upgrade from Piper Sandler, raising the price target from $220 to $235 [3] - Parsons Corporation gained 6.9% to $80.64 after being awarded a task order for Indo-Pacific Counter-Nuclear Smuggling System Deployment [3] - e.l.f. Beauty, Inc. shares increased by 4.6% to $149.91, with B of A Securities maintaining a Buy rating and raising the price target from $135 to $160 [3]
Roivant Sciences (NasdaqGS:ROIV) Earnings Call Presentation
2025-09-17 12:00
VALOR Study Topline Results - The VALOR study of Brepocitinib in Dermatomyositis (DM) succeeded with highly significant, robust, and consistent data across primary and all key secondary endpoints[18] - A consistent dose response was observed between 15 mg and 30 mg, establishing 30 mg as the optimal dose[18] - Brepocitinib 30 mg showed a mean TIS of 46.5, a delta of >15 points (p=0.0006) relative to placebo at week 52 (TIS of 31.2)[18] - Over two-thirds (68%) of brepocitinib 30 mg patients experienced at least a moderate response (TIS40), compared to 44.3% on placebo[37,61] - Nearly half (46.1%) of brepocitinib 30 mg patients experienced a major response (TIS60), compared to 26.4% on placebo[37,61] - Median time to a TIS40 response was approximately 2 months[18] - At week 52, 54.3% of patients achieving TIS40 Response + ≤2.5 mg OCS on Brepocitinib 30mg vs 26.6% on Placebo[61] - At week 52, CDASI-A change from baseline at -11.7 for Brepocitinib 30mg vs -7.0 for Placebo[61] Safety and Regulatory - The safety profile of Brepocitinib 30 mg in VALOR was consistent with prior clinical studies[18] - FDA filing is planned for the first half of 2026[18]
Roivant and Priovant Announce Positive Phase 3 VALOR Study Results for Brepocitinib in 52-Week Placebo-Controlled Trial in Dermatomyositis (DM)
Globenewswire· 2025-09-17 11:00
Core Insights - Roivant and Priovant Therapeutics announced positive results from the Phase 3 VALOR study for brepocitinib in treating dermatomyositis (DM) [1][2] Study Results - Brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo, with a statistically significant p-value of 0.0006 [2][5] - This study marks the first positive outcome for a 52-week placebo-controlled trial in DM and the first positive registrational trial for a targeted therapy in DM [2][3] - Brepocitinib demonstrated clinically meaningful and statistically significant improvements across all nine key secondary endpoints [3][5] Patient Outcomes - Approximately 75% of patients entered the study on background steroids, with a mean baseline dose of 12.2 mg/day for the brepocitinib group and 11.3 mg/day for placebo [4] - 62% of brepocitinib 30 mg patients achieved a steroid dose of ≤2.5 mg/day by the end of the study, compared to 34% for placebo [4] - More than two-thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major response (TIS≥60) [5][6] Safety Profile - The safety profile of brepocitinib 30 mg was consistent with previous clinical trials, with no increased frequency of adverse events of special interest compared to placebo [5][7] - The median time to a TIS≥40 response was approximately 8 weeks, indicating a rapid onset of clinical improvement [6] Future Plans - An NDA filing for brepocitinib in dermatomyositis is planned for the first half of 2026 [5][8] - Roivant will host an investor call to discuss these updates on September 17, 2025 [11] Background Information - Dermatomyositis is a debilitating autoimmune disease affecting approximately 50,000 adults in the U.S., characterized by muscle weakness and skin lesions [9] - The VALOR study is noted as the longest and largest interventional DM study ever conducted, enrolling 241 subjects globally [10]
Roivant Named on Fortune Media and Great Place To Work's 2025 Best Workplaces in BioPharma List
Globenewswire· 2025-09-11 20:30
Group 1 - Roivant has been recognized as one of the 2025 Fortune Best Workplaces in BioPharma, ranking 28th in the small & medium category, marking its first appearance on this prestigious list [1][3] - The award is based on survey responses from nearly 40,000 employees at Great Place To Work Certified companies in the biotechnology and pharmaceutical industry, reflecting a comprehensive picture of workplace experiences [2][4] - The selection process involved over 1.3 million survey responses from employees across the U.S., with rankings derived from 60 employee experience questions within the Great Place To Work Trust Index™ Survey [5] Group 2 - The recognition highlights Roivant's commitment to fostering an empowering, high-performance, and talent-oriented culture, as stated by the CEO [3] - The Best Workplaces in BioPharma list is highly competitive, with companies evaluated on their ability to provide positive outcomes for employees across various demographic identifiers [4][5] - Roivant is a biopharmaceutical company focused on accelerating the development and commercialization of impactful medicines, with a diverse pipeline targeting various medical conditions [10][11]
Roivant Sciences Ltd. (ROIV) Wins Orphan Drug Status in Japan for Mosliciguat
Yahoo Finance· 2025-09-11 15:11
Core Insights - Roivant Sciences Ltd. is highlighted as a promising investment opportunity in the healthcare sector, particularly in the biopharmaceutical space [1][4] Company Overview - Roivant Sciences Ltd. (NASDAQ:ROIV) is a clinical-stage biopharmaceutical company that accelerates the development of medicines through its subsidiaries, known as "Vants" [2] - The company focuses on in-licensing drug candidates from larger pharmaceutical firms and advancing them toward commercialization [2] Pipeline and Recent Developments - The current pipeline includes mosliciguat for pulmonary hypertension, brepocitinib for inflammatory diseases, and IMVT-1402 targeting autoimmune conditions [2] - A significant milestone for Roivant is the advancement of mosliciguat, which has received orphan drug designation in Japan, providing regulatory benefits and potential market exclusivity [3] - The Pulmovant subsidiary is positioned to address an underserved market in pulmonary hypertension with limited treatment options [3] Strategic Focus and Market Position - Roivant's brepocitinib program is progressing toward critical Phase 3 data readouts, which is fostering optimism among investors and analysts [4] - The company's strategic focus on rare and immune-mediated diseases enhances its attractiveness as a high-potential biotech investment [4]
Roivant Sciences(ROIV) - 2026 Q1 - Earnings Call Presentation
2025-08-11 12:00
Business Highlights - Roivant completed a $1.5 billion share repurchase program in June 2025, repurchasing approximately 149 million shares at an average price of $10.09, reducing the share count by over 15%[23] - The company expanded its pipeline by initiating 6 potentially registrational studies and 3 proof-of-concept (POC) studies[23] - Roivant increased shareholder exposure to clinical and litigation catalysts over the next 36 months[23] Brepocitinib Program - Topline data from the Phase 3 VALOR study of brepocitinib in dermatomyositis (DM) is expected in the second half of 2025[20, 27] - The VALOR study enrolled 241 adults with active DM, with 38% from the US, 32% from the EU, and 30% from the rest of the world[35] - Approximately 40% of subjects taking oral corticosteroids (OCS) at baseline in the VALOR study were able to eliminate OCS entirely by the end of the study[45] LNP Litigation - Summary judgment phase is ongoing in the US Moderna case, with a jury trial scheduled for March 2026[18, 27, 52] - Ongoing progress is expected in the Pfizer/BioNTech case following the Markman hearing, with a decision potentially in 2025[18, 27, 52] Financial Update - Research and development (R&D) expense was $153 million, with an adjusted R&D expense of $141 million (non-GAAP)[58] - General and administrative (G&A) expense was $134 million, with an adjusted G&A expense of $63 million (non-GAAP)[58] - Roivant had $4.5 billion in cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2025[58]
Roivant Reports Financial Results for the First Quarter Ended June 30, 2025, and Provides Business Update
Globenewswire· 2025-08-11 11:00
Core Insights - Roivant reported financial results for Q1 ended June 30, 2025, highlighting clinical progress and a completed $1.5 billion share repurchase program [1][2] - The company is preparing for the potential launch of brepocitinib, which targets high unmet medical needs [2][4] Recent Developments - The VALOR Phase 3 study for brepocitinib in dermatomyositis is on track for topline data readout in H2 2025, with the last patient visit completed in July [4][5] - Rapid enrollment is ongoing for brepocitinib in non-infectious uveitis and cutaneous sarcoidosis, with readouts expected in H1 2027 and H2 2026, respectively [4][5] - Immunovant initiated two potentially registrational studies for IMVT-1402 in Graves' disease and Sjögren's disease in June 2025 [5] Financial Summary - As of June 30, 2025, Roivant had consolidated cash, cash equivalents, restricted cash, and marketable securities totaling approximately $4.5 billion [6][8] - Research and development expenses increased by $32.4 million to $152.9 million compared to the same period in 2024, driven by program-specific costs and personnel-related expenses [9][10] - General and administrative expenses rose by $34.1 million to $134.0 million, primarily due to increased share-based compensation [12][14] Share Repurchase Program - Roivant completed its initial $1.5 billion share repurchase program, including $208 million in repurchases for the quarter, reducing outstanding shares by over 15% from March 31, 2024 [4][6] - A new $500 million share repurchase program was approved by the board in June 2025 [6] Upcoming Milestones - Topline data from the ongoing Phase 3 trial of brepocitinib in dermatomyositis is expected in H2 2025 [13] - Remission data from the batoclimab proof-of-concept study in Graves' disease will be reported at the American Thyroid Association Annual Meeting in September 2025 [13]