Biopharmaceuticals

搜索文档
Idorsia’s JERAYGO (aprocitentan) approved in Switzerland for the treatment of resistant hypertension
Globenewswire· 2025-09-19 13:00
Idorsia receives approval from Swissmedic for JERAYGO™ (aprocitentan) as the first and only endothelin receptor antagonist (ERA) for the treatment of resistant hypertension.JERAYGO is a new oral antihypertensive therapy – the first systemic hypertension treatment to target a new pathway in over 30 years. Allschwil, Switzerland – September 19, 2025Idorsia Ltd (SIX: IDIA) announces that Swissmedic has granted marketing authorization for JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in ad ...
Nektar Therapeutics (NASDAQ:NKTR) Sees Promising Clinical Results
Financial Modeling Prep· 2025-09-19 12:00
股价表现与市场定位 - 公司当前股价为5876美元 市值约112亿美元[5] - 股价单日涨幅超过15% 创下5881美元的52周新高 远高于过去一年最低点645美元[2][5] - 杰富瑞分析师设定99美元目标价 隐含6854%上涨空间[1][6] 临床研究突破 - rezpegaldesleukin在2b期研究中达到主要和关键次要终点[3] - 高剂量组在改善湿疹面积和严重程度指数方面具有统计学显著性[3] - 持续治疗患者获得更显著疗效收益[3] 药物试验数据 - 从安慰剂转为高剂量治疗24周后 EASI-75应答率提升至62%[4][6] - vIGA-AD 0/1应答率达到38%[4][6] - 研究结果在2025年欧洲皮肤病与性病学会大会上发布[3][4] 行业表现对比 - 公司股价表现显著超越标普500指数05%的涨幅[2] - 专注于免疫学和肿瘤学领域创新疗法开发[1] - 针对中重度特应性皮炎未满足医疗需求提供治疗方案[2]
Jim Cramer on Summit Therapeutics: “We’re Going to Have to Move On”
Yahoo Finance· 2025-09-19 11:25
Summit Therapeutics Inc. (NASDAQ:SMMT) is one of the stocks on Jim Cramer’s radar. A caller asked for Cramer’s opinion on the stock following recent negative news related to its cancer screening drug. He said: “No, no, we’re going to have to move on. Sometimes, when you have these things, they just don’t come back. That was a bad one. I’m sorry. I’d love to be able to say, don’t worry about it, but I’m going to, I know that there’s… insider buying. You don’t have to, have to [be in a] hurry to get out of ...
DEADLINE NEXT WEEK: Berger Montague Advises Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) Investors to Contact the Firm Before September 24, 2025
Globenewswire· 2025-09-19 05:06
PHILADELPHIA, Sept. 18, 2025 (GLOBE NEWSWIRE) -- National plaintiffs’ law firm Berger Montague PC is investigating securities fraud claims against Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) (“Spectrum” or the “Company”) on behalf of investors who purchased or otherwise acquired common shares of Spectrum between March 17, 2022 through September 22, 2022 (the “Class Period”). Investor Deadline: Investors who purchased or acquired Spectrum securities during the Class Period may, no later than September 24, ...
Savara Inc. Sued for Securities Law Violations – Investors Should Contact The Gross Law Firm Before November 7, 2025 to Discuss Your Rights – SVRA
Globenewswire· 2025-09-19 04:44
公司相关法律事件 - Gross Law Firm向Savara Inc (NASDAQ: SVRA)股东发布集体诉讼通知 涉及2024年3月4日至2025年5月23日期间购入股票的投资者[1][3] - 指控内容包括公司对MOLBREEVI BLA的化学制造与控制信息披露不足 FDA不太可能以当前形式批准该药物治疗肺泡蛋白沉积症的申请[3] - 公司被指需额外融资 因MOLBREEVI监管批准延迟可能影响资金状况 此前公开声明被指控存在重大虚假和误导性内容[3] 诉讼程序安排 - 股东参与截止日期为2025年11月7日 需通过指定链接完成登记[4] - 登记股东将接入案件生命周期监控系统 原告代表申请同步截止[4] - 律所提供免费参与通道 不要求必须成为原告代表即可获得赔偿资格[1][4]
DBV Technologies Announces Resignation of Board Member
Globenewswire· 2025-09-19 04:30
Châtillon, France, September 18, 2025 DBV Technologies Announces Resignation of Board Member DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Market: DBVT), (the “Company” or “DBV”), a clinical-stage biopharmaceutical company, today announced the resignation of Daniel Soland, as a member of its Board of Directors (the “Board”), effective immediately. “On behalf of the Board, DBV’s management team and shareholders, I thank Daniel for his commitment to the Company,” said Michel de Rosen, Chairm ...
Palisade Bio Announces Adjournment of Special Meeting of Stockholders Due to Lack of Quorum
Globenewswire· 2025-09-19 04:05
Carlsbad, CA, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”, or the “Company”), a clinical-stage biopharmaceutical company advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that the Company’s special meeting of stockholders held on September 18, 2025 at 9:00 a.m. Pacific Time was convened and adjourned, without any business being conducted, due to lack of the required quorum. A quorum cons ...
Geron Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-09-19 04:01
FOSTER CITY, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN), a commercial stage biopharmaceutical company, today reported that it has granted equity awards covering an aggregate of 966,000 shares of its common stock, consisting of stock options to purchase an aggregate of 644,000 shares of common stock, and restricted stock units (“RSUs”) representing an aggregate of 322,000 shares of common stock, to sixteen newly hired employees as an inducement material to their acceptance of ...
Eli Lilly's Oral GLP-1 Breakthrough Could Change Everything
MarketBeat· 2025-09-19 03:25
公司股价表现 - 过去12个月公司股票表现优异 是AI增强的"瑰丽7股"之外表现最佳的股票之一 [1] - 过去一个月股价上涨10% 主要受FDA可能加速审批口服GLP-1候选药物的消息推动 [2] - 过去五年股价上涨近400% 尽管最近一年半被部分交易员称为"僵尸股" [8] - 当前股价761.52美元 52周区间为623.78-939.86美元 [1] - 分析师给出的12个月目标价平均为939.61美元 较当前价格有23.73%上行空间 [3] GLP-1市场地位 - 公司是GLP-1市场领导者 该市场正在改变2型糖尿病和肥胖症的治疗方式 [1] - 口服GLP-1解决方案可能重新定义该领域的可及性和成本动态 显著扩大GLP-1市场规模 [2] - 虽然多家公司都在测试口服GLP-1解决方案 但公司进展最为领先 [4] - 诺和诺德是主要竞争对手 但公司在药物开发速度和制造规模方面仍保持优势 [8] 口服GLP-1药物进展 - FDA可能通过新推出的1-2个月快速审查流程加速审批该药物 [4] - 口服给药方式若能降低成本 可能提高保险覆盖意愿 目前用于减肥的GLP-1药物很少被保险覆盖 [5] - 口服解决方案解决了用户不喜欢或不愿处理持续针头注射的问题 [2] 制造战略与投资 - 公司战略投资270亿美元用于美国制造业 [6] - 承诺50亿美元在弗吉尼亚州建设制造工厂 提高国内口服GLP-1候选药物和肿瘤药物的生产能力 [6] - 这是公司计划在美国建设的四个新设施中的第一个 [6] - 此举解决了两党对制药供应链脆弱性的担忧 减少关税风险 并可能获得监管机构的认可 [7] 财务指标与估值 - 市盈率为49.79倍 [1] - 远期市盈率为32倍 虽然高于其他大型制药公司 但相对于历史平均水平和GLP-1药物主导地位具有良好价值 [12][13] - 股息收益率为0.79% 年度股息为6美元/股 [10][13] - 股息已连续11年增长 派息比率约为39% 具有可持续性 [10][13] 产品管线与增长动力 - 除了GLP-1药物外 公司的肿瘤学和抗体药物偶联物管线提供进一步增长机会 [11] - 美国制造重点是一个战略护城河 可多元化收入基础并降低政治和物流风险 [11] - 肥胖治疗保险覆盖的不确定性可能影响短期盈利 但长期前景保持完整 [9]
Roivant Sciences (NASDAQ:ROIV) Stock Update and Phase 3 VALOR Study Results
Financial Modeling Prep· 2025-09-19 03:00
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]