Pharmaceuticals
Search documents
RARE Rises on Completion of Rolling Submission for AAV Gene Therapy
ZACKS· 2025-12-31 15:50
Key Takeaways RARE rises 15.5% after finishing its rolling BLA submission to the FDA for DTX401 in GSDIa.DTX401 aims to treat the underlying cause of GSDIa, a rare disorder with no approved drug therapies.RARE's BLA is backed by phase III data showing reduced cornstarch use and improved glucose control.Shares of Ultragenyx Pharmaceutical (RARE) were up 15.5% yesterday following the completion of the rolling submission of a biologics license application (“BLA”) to the FDA seeking approval for its AAV gene th ...
Wall Street Analysts Think Johnson & Johnson (JNJ) Is a Good Investment: Is It?
ZACKS· 2025-12-31 15:31
Core Viewpoint - The article discusses the reliability of brokerage recommendations, particularly focusing on Johnson & Johnson (JNJ), and emphasizes the importance of using these recommendations in conjunction with other analytical tools like the Zacks Rank for making informed investment decisions [1][5]. Brokerage Recommendations for Johnson & Johnson - Johnson & Johnson has an average brokerage recommendation (ABR) of 1.85, indicating a consensus between Strong Buy and Buy, based on 26 brokerage firms [2]. - Out of the 26 recommendations, 14 are classified as Strong Buy and 2 as Buy, representing 53.9% and 7.7% of total recommendations respectively [2]. Limitations of Brokerage Recommendations - Solely relying on brokerage recommendations may not be advisable, as studies indicate they often fail to guide investors effectively towards stocks with high potential for price appreciation [5]. - Analysts from brokerage firms tend to exhibit a positive bias in their ratings due to vested interests, issuing five "Strong Buy" recommendations for every "Strong Sell" [6][11]. Zacks Rank as an Alternative Indicator - The Zacks Rank, which categorizes stocks from 1 (Strong Buy) to 5 (Strong Sell), is presented as a more reliable indicator of near-term price performance, driven by earnings estimate revisions [8][12]. - Unlike the ABR, the Zacks Rank is timely and reflects the latest earnings estimates, making it a more effective tool for predicting stock price movements [13]. Current Earnings Estimates for Johnson & Johnson - The Zacks Consensus Estimate for Johnson & Johnson's current year earnings has remained stable at $10.87 over the past month, indicating analysts' optimism regarding the company's earnings prospects [14]. - The Zacks Rank for Johnson & Johnson is currently 2 (Buy), influenced by the recent changes in consensus estimates and other related factors [15].
FDA Fast-Tracks Axsome's Alzheimer's Agitation Drug, Stock Soars
Benzinga· 2025-12-31 15:30
On Wednesday, the U.S. Food and Drug Administration (FDA) accepted Axsome Therapeutics Inc.’s (NASDAQ:AXSM) supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for Alzheimer’s disease agitation.The FDA granted the application Priority Review designation and set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.A Priority Review designation means the FDA’s goal is to take action on an application within 6 months, compared to 10 months under ...
Axsome Therapeutics, Plug Power And Other Big Stocks Moving Higher On Wednesday - Aimei Health Technology (NASDAQ:AFJK), Axsome Therapeutics (NASDAQ:AXSM)
Benzinga· 2025-12-31 15:12
U.S. stocks were lower, with the Dow Jones index falling more than 100 points on Wednesday.Shares of Axsome Therapeutics, Inc. (NASDAQ:AXSM) rose sharply during Wednesday's session after the company announced it intends to file a new drug application in January for AXS-12 after receiving feedback from the FDA. Additionally, the company announced the FDA granted Priority Review to AXS-05 for Alzheimer’s Agitation.Axsome Therapeutics shares surged 16.1% to $172.90 on Wednesday.Here are some other big stocks r ...
Market Closes Out Strong 2025 Amidst Modest Year-End Trading
Stock Market News· 2025-12-31 15:07
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 ...
美股异动|Vanda Pharmaceuticals大涨超26%,旗下晕动症药物获美国FDA批准
Ge Long Hui· 2025-12-31 14:45
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) ...
BAYRY's 2025 Revival: Will the Momentum Continue in 2026?
ZACKS· 2025-12-31 14:12
Key Takeaways Bayer stock surged 121.6% in a year, far outpacing the industry, sector and the S&P 500.BAYRY is boosted by FDA label expansions for Nubeqa and Kerendia, plus approvals for Lynkuet and Hyrnuo.Bayer also gained from a favorable U.S. Supreme Court review signal in Roundup litigation.2025 has proved to be a turnaround for the German pharmaceutical giant Bayer (BAYRY) . Shares have skyrocketed 121.6% over the past year compared with the industry’s gain of 19.2%. The stock has also outperformed t ...
Market Closes 2025 with Mixed Futures Amid Strong Annual Gains; Tech and AI Drive Year-End News
Stock Market News· 2025-12-31 14:07
As 2025 draws to a close, U.S. stock markets are navigating a final trading day marked by mixed premarket activity and lingering sentiment from a three-day losing streak, despite a year of robust overall gains. Investors are closing their books on a noteworthy year, with major indexes poised for significant annual advances, largely fueled by the relentless surge in artificial intelligence (AI) and technology sectors. Today, Wednesday, December 31, 2025, marks a full trading day for stocks, operating during ...
年销超4亿复合磷酸氢钾注射液获批,医药市场持续扩容中!
Ge Long Hui· 2025-12-31 14:04
12月29日,又一药企复合磷酸氢钾注射液(膳维喜)获国家药监局批准上市,作为磷酸补充剂用于临床。这款年销超4亿元、同比增长27.3%的临床"硬通 货",在持续增长的市场中迎来了又一位竞争者。 在这次获批前,国内已有24家药企拥有该品种的生产批文,其中19家已通过一致性评价,市场竞争格局已相当稳定。然而,申报热情不减。目前仍有15家药 企提交了3类仿制药上市申请,正处于审评审批的阶段。这反映出企业对该品种市场价值的持续看好。 截图来源:全终端医院销售数据库 截图来源:企业公告 复合磷酸氢钾注射液是临床纠正成人及儿童低磷血症的关键药物,尤其在患者无法经口补充时,是维持生命体征稳定的静脉磷钾"精准补给方案"。与常规营 养制剂不同,其定位于满足特定临床场景下的电解质精准补充,属于治疗性刚需。该品种被纳入国家医保乙类目录多年,临床认知与使用已高度成熟。 市场数据印证了其价值。据摩熵医药数据库显示,该品种近三年在全终端医院市场保持稳定增长,2024年销售额突破4亿元,同比增长27.3%,在血液代用 品与灌注液品类中稳居市场前列。此次获批,正值该市场处于明确的扩容时期。 | 按受理号浏览(13) | 按品种浏览(1) | ...
Strong Momentum Lifted BeOne Medicines AG (ONC) in Q3
Yahoo Finance· 2025-12-31 13:51
Chautauqua Capital Management, a division of Baird Asset Management, is a boutique investment firm that released its third-quarter 2025 investor letter for the “Baird Chautauqua International and Global Growth Fund”. A copy of the letter can be downloaded here. Global equity markets delivered solid results in the third quarter, driven by the resolution of significant trade conflicts and a shift in U.S. monetary policy toward a more dovish stance. Baird Chautauqua International Growth Fund underperformed the ...