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MRNA Beats on Q2 Earnings & Sales, Stock Down on Lowered Sales View
ZACKS· 2025-08-02 02:26
财务表现 - 2025年第二季度每股亏损2.13美元,优于Zacks共识预期的2.99美元亏损,去年同期亏损为3.33美元 [1] - 季度总收入1.42亿美元,超过Zacks共识预期的1.27亿美元,但同比下降41% [1] - 产品销售额同比下降38%至1.14亿美元,主要来自Spikevax疫苗,mResvia疫苗贡献可忽略 [2] - 来自授权、合作及特许权使用费收入2800万美元,同比下降51% [3] 成本控制 - 销售及管理费用(SG&A)同比下降14%至2.3亿美元,主要因全面成本削减措施 [4] - 研发费用同比下降43%至7亿美元,因呼吸道项目临床研究时间调整及项目终止 [4] - 计划裁员10%,并将2025年研发费用指引下调至36-38亿美元(原指引41亿美元) [9] - 资本支出指引下调至3亿美元(原指引4亿美元) [9] 2025年展望调整 - 全年收入指引下调至15-22亿美元(原指引15-25亿美元),因英国合同收入延迟至2026年第一季度 [5] - 预计下半年收入占比将达全年指引的40-50%来自第三季度,其余来自第四季度 [8] - 预计2025年末现金及投资余额约60亿美元 [10] 产品管线进展 - 近期获FDA三项批准:mResvia疫苗扩展至高危18-59岁人群、Spikevax疫苗全面批准用于6个月至11岁儿童、新一代冷藏稳定版Spikevax疫苗mNexspike [11] - 流感疫苗mRNA-1010在三期研究中显示优于GSK已上市疫苗的效力,支持其单独上市及与COVID-19疫苗组合mRNA-1083的重新申报 [12][13] - 与默克合作开发的个性化癌症疗法intismeran autogene正在进行三项关键三期研究(黑色素瘤和非小细胞肺癌),并新增转移性黑色素瘤一线治疗的二期研究 [14][16] 知识产权与诉讼 - 英国上诉法院维持EP'949专利有效性,裁定辉瑞/BioNTech的Comirnaty疫苗侵权,该专利涉及化学修饰mRNA技术 [17]
Roche's Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD)
GlobeNewswire News Room· 2025-08-02 02:00
Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in nAMD, the leading cause of vision loss in people over the age of 60With two refills per year, Susvimo maintained vision and stabilised the retina for five years, with durability maintained in approximately 95% of patientsSusvimo was well tolerated over five years and has a well-characterised safety profile Basel, 01 August 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, five-year efficacy, safe ...
Roche’s Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD)
Globenewswire· 2025-08-02 02:00
产品疗效与安全性数据 - Susvimo在治疗新生血管性年龄相关性黄斑变性(nAMD)的5年长期扩展研究(Portal)中显示,约95%患者每6个月接受一次补充治疗前无需额外治疗[1] - 最佳矫正视力(BCVA)在Susvimo组基线为74.4字母,5年后为67.6字母;IVT-Susvimo组基线76.3字母,5年后68.6字母[3] - 50%患者在5年后视力优于20/40(Snellen测试),中央子区厚度(CST)保持稳定,Susvimo组较基线减少1.0µm,IVT-Susvimo组减少10.3µm[3] 临床研究设计 - Portal研究纳入352例nAMD患者,其中220例持续接受每6个月Susvimo补充治疗,132例从每月玻璃体内注射雷珠单抗转为Susvimo治疗[2] - Archway III期研究(n=415)采用3:2随机分组,比较每6个月Susvimo与每月雷珠单抗注射,主要终点为36周和40周平均BCVA变化[6] - 该研究是迄今最大规模的nAMD患者5年前瞻性临床随访队列[4] 产品技术优势 - Susvimo通过可补充的眼部植入物实现雷珠单抗持续给药,相比现有每月注射方案显著降低治疗频率[5] - 植入物通过门诊手术一次性植入,直接向眼内递送定制配方雷珠单抗,针对导致视力丧失的视网膜病变[5] - 定制配方雷珠单抗与玻璃体内注射产品Lucentis®具有不同特性[11] 疾病背景与市场潜力 - nAMD是60岁以上人群视力丧失主因,全球约2000万患者,随人口老龄化患病率将持续上升[9] - 该疾病由异常新生血管引发黄斑区肿胀/出血,导致中心视力急剧下降[9] - Susvimo目前是美国FDA批准用于nAMD、糖尿病黄斑水肿和糖尿病视网膜病变的唯一持续给药疗法[10] 公司研发定位 - 罗氏作为全球最大生物技术公司,通过Susvimo的创新给药系统重新定义nAMD治疗标准[12] - 该产品每半年一次的给药方案在真实临床环境中可能比传统注射更持久维持视力[2] - 研究数据强化了公司对Susvimo独特治疗方法的信心,认为其提供了替代频繁注射的有效方案[2]
Sarepta Therapeutics (SRPT) Announces Restructuring and ELEVIDYS Black Box Warning, EMA Recommends Refusal of Marketing Authorization, Securities Class Action Pending – Hagens Berman
GlobeNewswire News Room· 2025-08-02 01:10
SAN FRANCISCO, Aug. 01, 2025 (GLOBE NEWSWIRE) -- On July 16, 2025, Sarepta Therapeutics (NASDAQ: SRPT) announced a major restructuring that involves, in part, a 36% workforce reduction (500 employees) and other steps to annually save about $400 million. The company also agreed with the FDA to include a black box warning of acute liver injury and acute liver failure in Sarepta’s ELEVIDYS label. ELEVIDYS is the company’s gene therapy drug intended to treat a limited category of people with Duchenne muscular d ...
ALNY Q2 Earnings Top Estimates on Higher Amvuttra Revenues, Stock Up
ZACKS· 2025-08-02 00:51
Key Takeaways ALNY posted Q2 earnings of $0.32 per share, reversing a loss, on strong Amvuttra-driven revenue growth.Amvuttra sales more than doubled to $492M, aided by expanded label use and patient switches from Onpattro.Alnylam raised 2025 product revenue guidance to $2.65-$2.8B, up from its prior range of $2.05-$2.25B.Alnylam Pharmaceuticals, Inc. (ALNY) reported second-quarter 2025 earnings of 32 cents per share, in contrast to the Zacks Consensus Estimate of a loss of 3 cents. The improvement was due ...
FOLD Q2 Earnings Miss Mark, Revenues Beat on Higher Product Sales
ZACKS· 2025-08-02 00:51
Key Takeaways FOLD posted Q2 EPS of $0.01, missing estimates. Revenues rose 22% to $154.7M, topping expectations.Galafold sales hit $128.9M, up 12% at CER, while Pombiliti + Opfolda sales were $25.8M in Q2.FOLD kept its 2025 view unchanged, targeting 15-22% revenue growth and GAAP profitability in the second half.Amicus Therapeutics (FOLD) reported adjusted earnings of 1 cent per share for the second quarter of 2025, which missed the Zacks Consensus Estimate of 2 cents. The company had incurred a loss of 6 ...
美股异动丨莫德纳(MRNA.US)大跌超10%,下调2025年收入预期上限
格隆汇· 2025-08-01 23:26
Moderna(MRNA.US)盘中一度跌超10%,报26.56美元。公司公布第二季净亏损8.25亿美元,每股亏损2.13美元,低于预期的亏损2.97美元;新冠疫苗销量下 滑,营收同比跌41%至1.4亿美元,高于预期的1.1亿美元。去年同期净亏损13亿美元,每股亏损3.33美元。 由于疫苗运往英国的延迟,Moderna下调2025年收入预期的上限范围,目前预计全年营收将在15亿美元至22亿美元之间,较早前预期的最高上限减少3亿美 元。 ...
Moderna slashes full-year sales outlook, reduces headcount
Proactiveinvestors NA· 2025-08-01 23:23
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...
Does CorMedix (CRMD) Have the Potential to Rally 65.64% as Wall Street Analysts Expect?
ZACKS· 2025-08-01 22:56
股价目标分析 - CorMedix(CRMD)最新收盘价为11 67美元 过去四周涨幅0 4% 华尔街分析师给出的平均目标价19 33美元隐含65 6%上行空间 [1] - 6个短期目标价的标准差为0 82美元 最低目标价18美元(潜在涨幅54 2%) 最高目标价20美元(潜在涨幅71 4%) 标准差较小显示分析师共识度较高 [2] - 尽管共识目标价受投资者关注 但单纯依赖该指标可能带来投资失误 分析师设定目标价的能力和客观性长期受质疑 [3] 盈利预测修正 - 分析师对公司盈利前景的乐观情绪上升 EPS预测修正呈现强烈共识 这种趋势与短期股价走势存在强相关性 [11] - Zacks对本年度的共识预期过去一个月上调0 7% 仅见正面修正而无负面调整 [12] - 公司当前获Zacks排名第一(强烈买入) 位列4000多只股票前5% 该排名基于盈利预测相关的四项因素 具有审计验证的可靠记录 [13] 目标价可信度研究 - 全球多所大学研究表明 目标价作为股票信息常误导投资者 实证显示无论分析师共识度高低 目标价鲜少准确预测股价走向 [7] - 华尔街分析师虽掌握公司基本面数据 但常因机构业务关系设定过度乐观目标价 存在人为抬高目标价的现象 [8] - 目标价集群紧密(低标准差)表明分析师对股价变动方向和幅度共识度高 可作为研究基本面驱动力的起点 [9] 投资建议 - 投资者不应完全忽视目标价 但仅凭此决策可能导致投资回报不佳 需保持高度怀疑态度 [10] - 对CRMD而言 虽然共识目标价未必可靠 但其暗示的价格方向仍具参考价值 结合盈利预测修正趋势更具指导性 [14]
SHAREHOLDER REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Replimune
GlobeNewswire News Room· 2025-08-01 22:51
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Replimune To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $50,000 in Replimune between November 22, 2024 and July 21, 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, Aug. 01, 2025 (GLO ...