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PepGen Inc. (PEPG) Rating Upgraded With 135% Upside on FREEDOM Data
Yahoo Finance· 2025-09-30 15:50
PepGen Inc. (NASDAQ:PEPG) is among the best fast money stocks to buy now. H.C. Wainwright has reaffirmed its ‘Buy’ rating on PepGen Inc. (NASDAQ:PEPG), while increasing the price target to $12.00 from $8.00, implying a surge of nearly 135%. This optimism stems from the company’s 53.7% mean splicing correction at 15 mg/kg report in its FREEDOM single-dose study for DM1 patients, showcasing the highest level disclosed in DM1 patients till now. The research firm noted that this nearly 54% splicing correction ...
Pallas Capital Backs Monte Rosa Therapeutics, Inc. (GLUE) Amid Growth Prospects
Yahoo Finance· 2025-09-30 15:42
Monte Rosa Therapeutics, Inc. (NASDAQ:GLUE) is among the best fast money stocks to buy now. During the second quarter, Pallas Capital Advisors acquired a new position in Monte Rosa Therapeutics, Inc. (NASDAQ:GLUE) through the purchase of 13,182 shares of the company’s stock. According to the latest filing with the SEC, the firm’s investment in the company is approximately $59,000. There are many advocates for Monte Rosa Therapeutics, Inc. (NASDAQ:GLUE), and it comes as no surprise. The company has managed ...
Positive Trial Data Supports 43% Upside for Immuneering Corporation (IMRX)
Yahoo Finance· 2025-09-30 15:42
Immuneering Corporation (NASDAQ:IMRX) is among the best fast money stocks to buy now. Analysts at Mizuho have reaffirmed their ‘Outperform’ rating on Immuneering Corporation (NASDAQ:IMRX), while maintaining a price target of $10, implying a surge of about 43%. This optimism stems from the company’s positive clinical trial outcome for its lead drug candidate. On Wednesday, Immuneering Corporation (NASDAQ:IMRX) reported modified 9-month survival data from its Phase 2a trial of atebimetinib (atebi), together ...
Why Nuvation Bio Stock Is Skyrocketing Today
Yahoo Finance· 2025-09-30 15:33
Key Points Nuvation Bio enrolled the first patient in a late-stage study of Ibtrozi. The bigger story, though, was a Wall Street analyst's initiation of coverage on the stock. 10 stocks we like better than Nuvation Bio › Shares of Nuvation Bio (NYSE: NUVB) were skyrocketing 15.7% higher as of 11:20 a.m. ET on Tuesday. The big jump came after two positive developments for the cancer-focused drugmaker. Nuvation Bio announced on Tuesday morning that it has enrolled the first patient in its phase 3 cl ...
Krystal Biotech's Heavy Reliance on Vyjuvek: Growth Driver or Risk Factor?
ZACKS· 2025-09-30 15:21
Key Takeaways Vyjuvek is now approved for DEB patients from birth, with self-administration at home allowed.Vyjuvek posted $184.2M in 1H25 sales, with growth expected from the U.S., EU, and Japan labels.KRYS prioritizes oncology candidate KB707, with an FDA end-of-phase II meeting set for October.Krystal Biotech, Inc.’s (KRYS) lead drug Vyjuvek is a non-invasive, topical, redosable gene therapy approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa (DEB).Kryst ...
Reviva Pharmaceuticals Holdings (NasdaqCM:RVPH) 2025 Conference Transcript
2025-09-30 15:15
纪要涉及的行业或公司 * 公司为 Reviva Pharmaceuticals Holdings (纳斯达克代码: RVPH),一家专注于神经系统疾病新疗法的后期生物制药公司 [4][11] * 行业为生物技术/制药行业,具体领域为精神分裂症及其他神经精神疾病的治疗 [4][8] 核心观点和论据 公司核心资产与作用机制 * 公司旗舰产品为 brilaroxazine (RP-5063),一种用于治疗精神分裂症的后期研究阶段药物 [8][11] * 药物靶向上游目标,可同时调节功能失调的血清素、多巴胺通路并具有抗炎作用,其作用机制有别于现有疗法 [12][13] * 抗炎作用通过动物研究和超过800名患者的临床试验中的生物标志物(如促炎细胞因子和脑源性神经营养因子BDNF水平)得到证实 [12] 关键临床数据与疗效优势 * 在两项随机试验(二期234名患者,三期RECOVER 1研究411名患者)及长期开放标签扩展研究中,brilaroxazine 在主要终点PANSS总分上显示出稳健疗效 [13][25][27] * 主要终点数据显示出与安慰剂10分的分离度,据称比历史获批抗精神病药物(报告分离度在4分至8.4分之间)优效20%至50% [28][29][30] * 药物对阴性症状(精神分裂症的主要未满足需求)显示出持续且强劲的疗效,据称在两项随机试验中均表现一致,并得到生物标志物支持 [14][15][34] * 长期疗效数据突出,在一年治疗中几乎没有患者出现复发,而历史数据显示短期治疗停药率25%-50%,长期治疗复发率高达80% [16][33][44] * 在所有七个关键次要终点上均显示出具有统计学意义的疗效,表明其具有广谱疗效 [20] 安全性与耐受性特征 * 安全性特征优异,在超过一年的治疗中,运动副作用(EPS)发生率极低(低于1%),而历史数据中此类副作用是导致停药的主要原因之一 [17][40][45] * 内分泌副作用(如催乳素水平)和代谢副作用(如体重增加约1.2公斤,血糖血脂水平无显著恶化)表现良好,心脏和肝脏副作用与安慰剂相当 [18][41][42] * 在长期开放标签研究中,治疗中止率为35%,远低于历史数据中的50%-80%,归因于良好的安全性和持久的疗效 [43][44][47] 监管路径与未来计划 * 公司认为现有数据(两项随机试验和一项长期安全性研究)已满足提交新药申请(NDA)的法定要求 [19][49][50] * 长期安全性研究有303名患者完成6个月治疗,159名患者完成1年治疗,超过了监管指南要求(300名患者6个月,100名患者1年) [50][51] * 计划在2025年第四季度与FDA举行会议(可能为Type C),寻求关于提交NDA的反馈,预计在2025年12月获得反馈,这被视为公司重要的价值拐点 [19][48][52] * 公司探讨了两种NDA提交情景:最佳情况是基于现有数据在2026年初提交NDA,预计2027年初获批;基础情况是进行第二项三期研究(RECOVER 2),预计在2027年第三季度提交NDA [57][59][60] * 公司引用CAPLYTA(基于一项成功的三期研究和二期数据获批)和COBINIFY(有效为四周试验)作为有利的监管先例 [53][56] 竞争格局分析 * 讨论了精神分裂症治疗领域的三个后期竞争资产:LB Pharma的LB102(三期准备阶段)、Neuron的Evanomide(三期进行中)和Neurocrine的NBI-117568 [8][63] * 公司认为其方法优于竞争对手:LB102基于氨磺必利,可能仍有催乳素升高和运动副作用;Evanomide是辅助疗法,可能难以解决继发性阴性症状和长期可持续性;Neurocrine的毒蕈碱类药物缺乏剂量依赖性疗效,且机制上可能无法解决血清素功能障碍 [65][66][67][68][69] 其他重要内容 * 分析师对RVPH股票的评级为"买入",12个月目标价为3美元 [7] * 公司管理层在会议期间及后续几周内可供安排一对一会议 [2][72] * 药物除了精神分裂症,还有潜力用于治疗双相情感障碍、重度抑郁症和注意力缺陷多动障碍(ADHD) [12]
BRNS Stock Alert: Halper Sadeh LLC Is Investigating Whether the Merger of Barinthus Biotherapeutics plc Is Fair to Shareholders
Businesswire· 2025-09-30 15:03
NEW YORK--(BUSINESS WIRE)--Halper Sadeh LLC, an investor rights law firm, is investigating whether the merger of Barinthus Biotherapeutics plc (NASDAQ: BRNS) and Clywedog Therapeutics, Inc. is fair to Barinthus shareholders. Under the terms of the agreement, Barinthus shareholders will receive one share of common stock in the new combined company for each American Depositary Share or ordinary share owned, and Clywedog shareholders will receive 4.358932 shares of common stock in the new combined. ...
Dow Falls Over 100 Points; Paychex Shares Fall After Q1 Results - Sunrise New Energy (NASDAQ:EPOW), Beneficient (NASDAQ:BENF)
Benzinga· 2025-09-30 14:53
美股市场整体表现 - 美股周二早盘走低,道琼斯指数下跌超过100点 [1] - 道琼斯指数下跌0.26%至46,195.25点,纳斯达克指数下跌0.21%至22,544.07点,标普500指数下跌0.17%至6,649.65点 [1] 行业板块表现 - 医疗保健股上涨0.8% [1] - 能源股下跌1.7% [1] 个股重大消息 - Paychex股价下跌约4%,公司公布2026财年第一季度销售额增长17%至15.4亿美元,超出分析师预期的15.38亿美元 [2] - Paychex调整后每股收益为1.22美元,超出分析师预期的1.21美元,并将2026财年调整后每股收益指引从5.40-5.50美元上调至5.43-5.53美元 [2] 个股显著波动 - Zhengye Biotechnology Holding Limited股价飙升70%至3.72美元 [8] - Beneficient股价大涨62%至0.5898美元,公司公布了第四季度业绩 [8] - Sunrise New Energy Co., Ltd.股价上涨52%至1.37美元,公司子公司获得一项锂离子电池阳极材料制备方法的美国专利 [8] - Erayak Power Solution Group Inc.股价下跌45%至4.6888美元 [8] - NovaBay Pharmaceuticals, Inc.股价下跌13%至1.35美元 [8] - Mingteng International Corporation Inc.股价下跌34%至4.1002美元 [8] 商品市场表现 - 油价下跌1.8%至62.33美元 [4] - 金价上涨0.5%至3,875.40美元 [4] - 银价下跌0.4%至46.825美元,铜价下跌0.5%至4.8680美元 [4] 欧洲及亚太市场 - 欧洲斯托克600指数上涨0.2%,西班牙IBEX 35指数上涨0.8%,英国富时100指数上涨0.4%,德国DAX指数上涨0.2%,法国CAC 40指数下跌0.3% [5] - 日本日经225指数下跌0.25%,香港恒生指数上涨0.87%,中国上证综指上涨0.52%,印度孟买Sensex指数下跌0.12% [6] 经济数据 - 美国8月职位空缺增加1.9万个至722.7万个 [10] - 9月芝加哥PMI商业景气指数从41.5下降至40.6,低于市场预期的43 [10] - 7月S&P CoreLogic Case-Shiller房价指数同比上涨1.8% [10] - 7月FHFA房价指数环比下降0.1% [10] - 达拉斯联储9月整体商业活动指数下降12点至-5.6 [7]
INVESTOR DEADLINE APPROACHING: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Jasper
Globenewswire· 2025-09-30 14:40
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Jasper To Contact Him Directly To Discuss Their Options If you suffered losses in Jasper between November 30, 2023 and July 3, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a le ...
INVESTOR ALERT: Investigation of MoonLake Immunotherapeutics (MLTX) Announced by Holzer & Holzer, LLC
Globenewswire· 2025-09-30 14:27
公司事件概述 - 律师事务所Holzer & Holzer, LLC正在调查MoonLake Immunotherapeutics (NASDAQ: MLTX) 是否遵守了联邦证券法 [1] - 调查背景是MoonLake于2025年9月28日公布了其VELA-1和VELA-2三期项目的结果 [1] - 公司披露在VELA-2研究中,安慰剂组发生的高于预期的并发事件导致研究未能使用复合策略在16周主要终点达到统计学显著性 [1] - 此消息公布后,公司股价出现下跌 [1] 公司临床研究结果 - VELA-2三期项目的16周主要终点未达到统计学显著性 [1] - 研究失败的原因被归咎于安慰剂组中高于预期的并发事件 [1]