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Zura's Make-or-Break Year Ahead: Will TibuSHIELD And TibuSURE Trials Deliver Or Disappoint?
RTTNews· 2025-10-07 20:44
2026 could be a pivotal year for Zura Bio Ltd. (ZURA), with key data readouts for its lead investigational drug expected to significantly influence the company's strategic direction and market position.Zura is a clinical-stage, multi-asset immunology company advancing treatments for immune-mediated diseases where there is an unmet medical need. Its lead product candidate is Tibulizumab, a potential first-in-class dual-pathway biologic designed to target cytokines IL-17A and BAFF. Tibulizumab is currently b ...
3 Reasons Growth Investors Will Love Novartis (NVS)
ZACKS· 2025-10-07 01:46
Growth investors focus on stocks that are seeing above-average financial growth, as this feature helps these securities garner the market's attention and deliver solid returns. But finding a growth stock that can live up to its true potential can be a tough task.In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.However, the task of finding cutting-edge growth stocks is made ...
2 Surefire Dividend Stocks to Buy for the Long Haul
Yahoo Finance· 2025-10-04 21:37
Key Points Novartis and Gilead Sciences have businesses that can perform well during downturns. Novartis has an extensive portfolio of medicines across many therapeutic areas. Gilead Sciences leads the HIV market and is expanding its oncology lineup. 10 stocks we like better than Novartis › Equity markets experienced significant volatility this year. Many investors feared that President Donald Trump's aggressive trade policies would plunge the economy into a recession and lead to a full-blown sto ...
Novartis: Superstars Entresto And Kisqali Fuel Market Outperformance (NYSE:NVS)
Seeking Alpha· 2025-10-03 20:56
Just three months have passed since the publication of my last article on Novartis AG (NYSE: NVS ), "Why Novartis Is Still a 'Buy' After 15% Surge."With over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, technology, and pharmaceutical companies.Allka Research's journey in the investment landsc ...
Novartis: Superstars Entresto And Kisqali Fuel Market Outperformance
Seeking Alpha· 2025-10-03 20:56
Just three months have passed since the publication of my last article on Novartis AG (NYSE: NVS ), "Why Novartis Is Still a 'Buy' After 15% Surge."With over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, technology, and pharmaceutical companies.Allka Research's journey in the investment landsc ...
美股异动|诺华股价三连阳眼科业务出售引发市场关注
新浪财经· 2025-10-01 07:31
公司股价表现 - 诺华股价在9月30日上扬,并已连续三天表现强劲 [1] 诺华公司战略调整 - 诺华正在进行全球业务重组,眼科业务的调整是其重要战略举措之一 [1] - 公司通过剥离爱尔康和出售部分药品来精简赛道,专注于心血管、肾脏、代谢及肿瘤四大核心领域 [1] - 在中国市场,诺华计划通过出售成熟的眼前节产品来释放资源,以集中力量发展核心业务 [1] - 诺华过去曾在中国眼科市场占据主导地位,但不断变化的全球战略和市场竞争力的调整促使公司重新定义业务重心 [1] - 诺华在眼科领域面临多方竞争压力,随着新药法瑞西单抗等产品的出现,其市场份额逐渐被蚕食,眼底病变药物销售额出现下滑趋势 [2] - 生物类似药的涌现将进一步压低药品价格,使跨国药企在眼科领域的竞争变得更加复杂 [2] 潜在交易分析 - 近期市场广泛关注诺华眼科业务可能出售给中国康哲药业的消息 [1] - 康哲药业过去与诺华有良好合作关系,对收购诺华成熟业务有一定经验 [2] - 该交易若完成,可能为中国眼科市场格局带来新的变化 [2] 中国眼科市场竞争格局 - 中国眼科市场竞争愈发激烈,拥有多款创新药的康弘药业正逐步提升市场份额 [1] - 康哲药业凭借强大的商业化渠道,逐步转型为创新药企并积极在眼科领域布局 [1] - 若康哲药业接手诺华眼科业务,其“渠道广度”与康弘药业的“研发深度”之间的竞争将成为未来市场看点 [2] - 市场变动不仅受益于老龄化带来的需求增长,也反映了跨国药企的策略性转移,为本土企业提供更多机遇 [1]
US FDA approves Novartis' drug for skin disease
Reuters· 2025-10-01 04:22
The U.S. Food and Drug Administration has approved Novartis' oral treatment for patients with type of chronic inflammatory skin disease, the company said on Tuesday. ...
Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)
Globenewswire· 2025-10-01 04:15
产品获批与核心特点 - Rhapsido(remibrutinib)获得美国FDA批准,用于治疗经H1抗组胺药治疗后仍有症状的慢性自发性荨麻疹成人患者[2] - 该产品是首个也是唯一一个获FDA批准用于CSU的布鲁顿酪氨酸激酶抑制剂,每日口服两次,无需注射或实验室监测[2] - Rhapsido通过靶向BTK抑制组胺和其他促炎介质的释放,为CSU治疗提供了独特方法[2][7] 疾病背景与市场潜力 - 慢性自发性荨麻疹是一种肥大细胞驱动的疾病,诊断可能长达24个月,症状不可预测且持续六周以上,严重影响患者睡眠、工作和心理健康[3][4] - 美国有170万CSU患者,超过一半的患者即使增加抗组胺药剂量后仍有症状,而现有注射疗法在符合条件的患者中使用率低于20%[4][7] 临床试验数据 - FDA批准基于III期REMIX-1和REMIX-2临床试验结果,显示在第12周时,Rhapsido在瘙痒、荨麻疹和每周荨麻疹活动度方面优于安慰剂[6] - 接受Rhapsido治疗的患者早在第2周就实现了疾病良好控制,约三分之一患者在12周时实现完全无瘙痒和无荨麻疹[6] - 最常见的不良事件(发生率≥3%)包括鼻塞、咽喉痛、流鼻涕、出血、头痛、恶心和腹痛,其安全性特征无需实验室监测[6][8] 公司战略与未来发展 - 公司已完成Rhapsido在欧盟、日本和中国等多个国家的监管申报,并在中国获得优先审评资格[8] - remibrutinib正在针对慢性诱导性荨麻疹、食物过敏和化脓性汗腺炎等多种免疫相关疾病进行临床开发,以扩大公司的免疫学产品组合[7][9] - 公司致力于通过投资创新的、以患者为中心的免疫学疗法,重塑被忽视的免疫相关疾病的治疗模式[9]
Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)
Globenewswire· 2025-10-01 04:15
产品获批与核心特性 - 诺华公司的Rhapsido® (remibrutinib) 获得美国FDA批准,用于治疗经H1抗组胺药治疗后仍有症状的慢性自发性荨麻疹成人患者 [2] - Rhapsido是首个也是唯一一个获FDA批准用于CSU的布鲁顿酪氨酸激酶抑制剂,每日口服两次,无需注射或实验室监测 [2] - 该药物通过靶向BTK抑制组胺和其他促炎介质的释放,为CSU治疗提供了独特的作用机制 [2][4] 临床数据与疗效 - FDA批准基于III期REMIX-1和REMIX-2临床试验结果,显示在第12周时,Rhapsido在瘙痒、荨麻疹和每周荨麻疹活动度评分上优于安慰剂 [3] - 接受Rhapsido治疗的患者在第2周和第12周实现疾病良好控制的比例显著高于安慰剂组,约三分之一患者在12周时瘙痒和荨麻疹完全消失 [3] - 药物安全性良好,无需实验室监测,最常见不良事件(发生率≥3%)包括鼻塞、喉咙痛、流涕、出血、头痛、恶心和腹痛 [5] 疾病背景与市场潜力 - 美国有170万CSU患者,超过一半的患者即使增加抗组胺药剂量仍存在症状 [4] - CSU是一种肥大细胞驱动的疾病,诊断可能长达24个月,症状不可预测,持续六周或更长时间,对患者睡眠、工作和心理健康产生负面影响 [2] - 抗组胺药是一线治疗,但超过半数患者症状持续,对于抗组胺药应答不足的患者,现有注射疗法使用率低于20% [2] 公司战略与产品管线 - Rhapsido的获批是诺华重塑免疫相关疾病治疗的重要里程碑,公司致力于进一步投资于以患者为中心的创新免疫疗法 [6] - remibrutinib由诺华发现和开发,目前正在针对多种免疫相关疾病进行临床试验,包括慢性诱导性荨麻疹、化脓性汗腺炎和食物过敏 [6] - 公司已完成Rhapsido在多个国家的监管提交,包括欧盟、日本和中国,并在中国获得优先审评资格 [5]
Novartis to Launch Direct-to-Patient Platform for Cosentyx in U.S.
WSJ· 2025-09-29 20:53
公司行动 - 公司为最新一家采取降价措施的制药巨头 [1] 行业背景 - 行业在特朗普政府设定的截止日期前采取价格调整行动 [1]