评级与目标价调整 - 花旗将Roivant Sciences评级调整为中性 维持持有操作 当时股价为15.47美元 [1] - 美国银行将Roivant目标价从12美元上调至16.50美元 [1][6] 临床研究进展 - 公司公布brepocitinib治疗皮肌炎的三期VALOR研究取得积极结果 在主要终点和全部九个关键次要终点均显示显著改善 [2] - 30mg每日剂量组第52周总改善评分(TIS)达46.5 显著优于安慰剂组的31.2 (p=0.0006) [3] - 超过三分之二患者达到至少中等应答 近半数患者实现主要应答 [3] 监管申请计划 - 计划在2026年上半年提交新药申请(NDA) [4][6] - brepocitinib显示出持续的安全性特征 [4] 股价与交易表现 - 当前股价14.99美元 较前下跌1.93%或0.30美元 [4] - 当日交易区间为14.98-15.52美元 [4] - 年內最高价16.05美元 最低价8.73美元 [5] - 当前市值约102.3亿美元 [5] - 当日成交量2,323,718股 显示投资者活跃兴趣 [5]

Roivant Sciences Ltd. (ROIV) shares ended the last trading session 7.8% higher at $15.28. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 20.6% gain over the past four weeks.Roivant shares gained after the company, along with its partner, Priovant Therapeutics, announced that their investigational candidate, brepocitinib, met the primary endpoint and all nine key secondary endpoints, with statistical significance, ...

PresentationLadies and gentlemen, thank you for standing by. Welcome to VALOR Phase III study results [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to Stephanie Lee. Please go ahead.Stephanie Lee GriffinChief Operating Officer of Roivant Platforms Good morning, and thanks for joining today's call to review the VALOR Phase III study results. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant; ...

主要股指表现 - 标普500指数下跌0.17% 道琼斯工业指数上涨0.77% 纳斯达克100指数下跌0.80% [1] - 欧洲斯托克50指数上涨0.11% 中国上证综指上涨0.37% 日经225指数下跌0.25% [6] 美联储政策与利率 - 美联储批准25个基点降息 预计年底前还将进行两次降息 [1] - 市场预期FOMC会议将降息25个基点 关注点阵图是否显示年内累计降息约70个基点 [5] - 10年期美债收益率上升0.6个基点至4.034% [7] 住房市场数据 - 8月新屋开工月率下降8.5%至130.7万套 低于预期的136.5万套 [3] - 8月建筑许可月率意外下降3.7%至131.2万套 创5.25年新低 低于预期的137万套 [3] - 9月12日当周MBA抵押贷款申请增长29.7% 其中购房抵押贷款子指数增长2.9% 再融资子指数大幅增长57.7% [4] - 30年期固定抵押贷款利率下降10个基点至6.39% 创11个月新低 [4] 科技股与芯片板块 - 英伟达下跌超过2% 因中国网信办要求大型企业终止RTX Pro 6000D芯片订单 [2][11] - 科技七巨头普遍下跌 亚马逊、特斯拉和Meta跌幅超1% Alphabet下跌0.77% 微软下跌0.34% [12] - Workday上涨超过8% 因Guggenheim证券将其评级从中性上调至买入 目标价285美元 [14] 个股表现与公司动态 - 曼联下跌超过6% 因报告第四季度亏损并下调2026年收入展望 [12] - Uber下跌超过4% 因SEC文件显示CEO出售2860万美元股票 [13] - Roivant Sciences大涨超过12% 其治疗皮肌炎药物在3期试验中达到主要终点 [14] - Zillow上涨超过3% 因Bernstein将其评级从市场表现上调至跑赢大盘 目标价105美元 [14] - 沃尔玛上涨超过2% 因美国银行将目标价从120美元上调至125美元 [15] - MasTec上涨超过1% 因Wolfe Research将其评级从同业表现上调至跑赢大盘 目标价227美元 [15] - Duolingo下跌超过3% 因匈牙利竞争管理局对其商业行为展开调查 [13] - Progressive下跌超过1% 因BMO资本市场将其评级从跑赢大盘下调至市场表现 [13] 国际通胀与利率 - 欧元区8月CPI下修至同比上涨2.0% 核心CPI维持在2.3% [9] - 英国8月CPI同比上涨3.8%与7月持平 核心CPI从3.8%放缓至3.6% [9] - 利率互换市场定价显示ECB在10月30日会议降息25个基点的概率为2% [9] - 10年期德国国债收益率下降1.5个基点至2.678% 英国国债收益率下降1.6个基点至4.623% [8] 经济数据预期 - 预计周四公布的周度初请失业金人数将减少2.3万人至24万人 [5]

Roivant Sciences Ltd ROIV and Priovant Therapeutics released results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM).Dermatomyositis is a chronic autoimmune disorder causing muscle inflammation and a distinctive skin rash, often purple or reddish, on areas like the face, knuckles, and upper chest.Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary en ...

U.S. stocks were mixed, with the Dow Jones index gaining more than 200 points on Wednesday.Shares of Lyft, Inc. LYFT rose sharply during Wednesday's session after the company and Waymo announced plans to expand to Nashville next year, with Lyft’s Flexdrive managing Waymo’s fully autonomous vehicles.Lyft shares jumped 13.5% to $22.92 on Wednesday.Here are some other big stocks recording gains in today’s session.New Fortress Energy Inc. NFE shares jumped 32.3% to $2.6501 after the company announced a long-ter ...

Roivant Sciences (NasdaqGS:ROIV) Update / Briefing September 17, 2025 08:00 AM ET Company ParticipantsStephanie Lee Griffin - COOMatt Gline - CEO & DirectorBenjamin Zimmer - CEOCorinne Johnson - Vice PresidentPrakhar Agrawal - Managing DirectorEmma Gutstein - Equity Research AssociateConference Call ParticipantsDennis Ding - VP - Equity Research AnalystBrian Cheng - Senior Biotech AnalystYaron Werber - MD & Senior Biotechnology AnalystSam Slutsky - MD & Senior Research AnalystSamantha Semenkow - VP - SMid B ...

Roivant and partner Priovant Therapeutics said on Wednesday that their experimental drug for a rare disease affecting both skin and muscle health has shown promising results in a late-stage clinical t... ...

业绩总结 - Brepocitinib 30 mg在52周时的平均总改善评分（TIS）为46.5，相较于安慰剂组的31.2，差值超过15分，p值为0.0006[18] - 241名参与者中，Brepocitinib 30 mg组的治疗完成率为93%，显著高于安慰剂组的82%[32] - 30 mg组中仅有15%的患者接受了救援药物，而安慰剂组则有30%[32] - Brepocitinib 30 mg组在第52周的CDASI-A（皮肤病活动评分）变化为-11.7，相较于安慰剂组的-7.0，P值为0.0006[61] - 30 mg组中，72%的患者在MMT-8（肌肉力量评分）中实现了7分的提升，而安慰剂组为54%[56] 用户数据 - 超过三分之二的Brepocitinib 30 mg患者经历至少中度反应（TIS40），近一半患者经历重大反应（TIS60）[18] - 在第52周，Brepocitinib 30 mg组中68%的患者达到了中度TIS反应（TIS40），而安慰剂组为44.3%，P值为0.0040[61] - 30 mg组中，42%的患者在第48-52周完全停用类固醇，而安慰剂组为23%[35] - 30 mg组中，36%的患者在第52周达到了中度TIS反应（TIS40）且每日口服类固醇≤2.5 mg，而安慰剂组为20%[44] - 30 mg组中，46.1%的患者在第52周达到了主要TIS反应（TIS60），而安慰剂组为26.4%，P值为0.0126[61] 新产品和新技术研发 - Brepocitinib的临床试验显示出快速、深度和广泛的反应，且在第4周即显著改善[18] - Brepocitinib 30 mg的安全性与之前的临床研究一致，FDA计划在2026年上半年提交申请[18] - VALOR研究是针对皮肌炎的首个成功注册试验，且是首个成功的52周安慰剂对照试验[25] 未来展望 - 目前皮肌炎的标准治疗方法自1980年代以来基本未变，患者对现代靶向治疗的需求极高[22] - Brepocitinib在所有10个预设终点上均取得统计学显著性[27] 负面信息 - 参与者的平均年龄为50.4岁，女性占比为80%[30] 其他新策略 - Priovant自2021年成立以来，由Benjamin Zimmer担任首席执行官[74] - Benjamin Zimmer在Roivant担任过首席运营官和Roivant Health总裁，负责多个项目的孵化和推出[74] - Benjamin Zimmer曾在麦肯锡担任顾问，并创办了一个专注于公共政策的非营利组织[74]

Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onsetOn the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006​), even with nearly twice as many patients coming off background steroid ...