Vanda表示，计划在未来几个月内正式推出Nereus。市场普遍认为，该药物的获批有望为公司带来新的 商业化增长点，并进一步丰富其在中枢神经及相关适应症领域的产品组合。 周三，万达生物制药(VNDA.US)股价走高，截至发稿，该股涨超32%，报9.33美元。消息面上，公司表 示，其新药Nereus已获得美国食品药品监督管理局(FDA)批准，该药物可用于预防由运动引发的呕吐。 公司称，FDA的批准决定基于三项临床研究结果。相关试验将用药组与安慰剂组进行对比，评估呕吐发 生情况。数据显示，Nereus在降低呕吐事件方面取得"显著减少"的效果，同时在短期、急性使用场景下 展现出"良好的安全性特征"。 ...

As Wednesday, December 31st, 2025, draws to a close, the U.S. stock market is wrapping up a remarkably strong year, despite a relatively subdued final trading session. Major indices opened with slight downward pressure today, reflecting a cautious mood as investors consolidate gains and look ahead to the new year. The S&P 500 (SPX), Nasdaq Composite (IXIC), and Dow Jones Industrial Average (DJIA) have all seen impressive annual growth, largely fueled by resilient corporate earnings and continued enthusiasm ...

美国制药商Vanda Pharmaceuticals(VNDA.US)大涨超26%，报8.9美元。消息面上，Vanda Pharmaceuticals 宣布，其用于预防运动诱发性呕吐的药物已获得美国食品药品监督管理局(FDA)批准，成为40多年来首 个获批的此类治疗药物。该公司预计将在未来几个月内推出这款名为Nereus的药物。(格隆汇) ...

Key Takeaways VNDA won FDA approval for tradipitant, branded Nereus, to prevent vomiting caused by motion sickness.Vanda Pharmaceuticals said Nereus is the first new motion sickness drug in more than 40 years.VNDA shares surged 18% after hours following the approval, extending gains into pre-market trading.Vanda Pharmaceuticals, Inc. (VNDA) announced that the FDA has approved its candidate tradipitant for the prevention of vomiting induced by motion.The drug has been approved under the brand name Nereus.Tra ...

The U.S. stock market is closing out 2025 on a cautious note, with futures for major indexes edging lower on Wednesday, December 31st, extending a three-session losing streak. Hopes for a traditional year-end "Santa Claus" rally appear to be fading, as investors grapple with mixed economic signals and a divided outlook from the Federal Reserve for the upcoming year. Despite the recent pullback, 2025 has been a remarkable year for equities, with the S&P 500 (SPX) poised for its third consecutive year of doub ...

Core Viewpoint - U.S. stock futures are trading lower, with several companies making headlines due to significant stock movements following recent announcements and earnings reports [1] Group 1: Company Announcements - Oriental Rise Holdings Ltd. announced a nonbinding letter of intent to acquire a controlling stake in Hubei Daguan Tea Industry Group, leading to a 47.5% increase in its share price to $1.80 in after-hours trading [1] - Vanda Pharmaceuticals Inc. received FDA approval for NEREUS (tradipitant), resulting in a 20.2% surge in its share price to $8.45 in after-hours trading [1] - One Stop Systems Inc. agreed to sell all assets of Bressner Technology GmbH for $22.4 million, while also lowering its FY2025 sales guidance due to the discontinuation of Bressner, leading to a 1.7% increase in its share price to $7.27 in after-hours trading [1] Group 2: Earnings Reports - Ellomay Capital Ltd. reported third-quarter earnings of 93 cents per share, up from 52 cents per share in the previous year, with sales increasing to $14.944 million from $13.555 million, resulting in a 16.6% rise in its share price to $26.20 [1] - FuelCell Energy Inc. filed for a common stock offering of up to $200 million, causing a 5% decline in its share price to $7.54 in after-hours trading [1]

Core Viewpoint - Vanda Pharmaceuticals Inc. has received FDA approval for NEREUS (tradipitant), leading to a significant increase in stock price by 20.20% to $8.45 in after-hours trading, indicating strong market interest in the new therapy for motion-induced vomiting in adults [1]. Clinical Efficacy - NEREUS showed efficacy in three pivotal clinical trials, with vomiting rates in treated patients ranging from 10.4% to 19.5%, compared to 37.7% to 44.3% in placebo groups, achieving risk reductions of over 50% to 70% [2]. - The Motion Syros trial involved 365 patients, while the Motion Serifos study included 316 patients, both demonstrating statistically significant results (p < 0.0001 and p ≤ 0.0014 respectively) [2]. Adverse Reactions - Common adverse reactions reported included somnolence in 6% to 12% of patients and fatigue in 6% to 8% [3]. Market Potential - Approximately 25% to 30% of U.S. adults, estimated at 65 million to 78 million people, experience motion sickness, with 5% to 15% suffering from severe, recurrent symptoms, highlighting a substantial market opportunity for NEREUS [4]. Pipeline Development - Vanda is also advancing tradipitant for other indications, including gastroparesis and nausea/vomiting prevention related to GLP-1 receptor agonists, indicating a broader therapeutic potential [5]. Trading Metrics - Vanda Pharmaceuticals has a market capitalization of $415.45 million, with a 52-week high of $7.47 and a low of $3.81. The stock has gained 47.07% over the past 12 months, reflecting a strong long-term trend [6]. - The stock is currently trading at 88% of its 52-week range, suggesting bullish sentiment, although it is approaching overbought levels [6]. Price Action - On the previous trading day, the stock closed at $7.03, down 2.36%, but maintains strong momentum in the 90th percentile, indicating a positive price trend across all time frames [7].

美国制药商Vanda Pharmaceuticals(VNDA.US)夜盘大涨超21%，报8.53美元。消息面上，Vanda Pharmaceuticals宣布，其用于预防运动诱发性呕吐的药物已获得美国食品药品监督管理局(FDA)批准， 成为40多年来首个获批的此类治疗药物。该公司预计将在未来几个月内推出这款名为Nereus的药物。 (格隆汇) ...

Vanda Pharmaceuticals said on Tuesday its drug for the prevention of motion-induced vomiting was approved by the U.S. health regulator, becoming the first treatment for the condition to receive the nod in more than 40 years. ...

Core Viewpoint - Vanda Pharmaceuticals has received FDA approval for NEREUS™ (tradipitant), marking the first new pharmacologic treatment for motion sickness in over 40 years, which is a significant advancement in managing this condition that affects a large portion of the population [1][2] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to address unmet medical needs and improve patient lives [9] - The company is advancing tradipitant for additional indications, including gastroparesis and nausea/vomiting induced by GLP-1 receptor agonists [6][10] Product Details - NEREUS™ is an oral neurokinin-1 (NK-1) receptor antagonist approved for the prevention of vomiting induced by motion in adults [11] - The drug's mechanism of action involves potent and selective antagonism of NK-1 receptors, addressing the sensory conflict that triggers nausea and vomiting [5] Clinical Evidence - The efficacy of NEREUS™ is supported by data from three pivotal clinical trials, showing significant reductions in vomiting incidence: - In Motion Syros (n=365), vomiting incidence was 18.3–19.5% with NEREUS™ compared to 44.3% with placebo (p<0.0001) - In Motion Serifos (n=316), vomiting rates were 10.4–18.3% with NEREUS™ versus 37.7% with placebo (p=0.0014), indicating risk reductions of over 50–70% [3] Market Context - Motion sickness affects approximately 25–30% of adults in the U.S., equating to roughly 65–78 million people, with up to one-third of individuals globally being highly susceptible [5] - A significant segment of the population experiences severe symptoms that can greatly impact quality of life, with tens of millions seeking pharmacologic treatment annually [5] Future Prospects - Vanda anticipates launching NEREUS™ in the coming months and is committed to expanding its therapeutic potential across indications driven by substance P-mediated pathways [7]