mRESVIA

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MRNA Stock Jumps on CDC's Revised RSV Vaccine Recommendations
ZACKS· 2025-07-03 14:11
Core Viewpoint - The U.S. CDC has adopted new recommendations for RSV vaccinations, lowering the age for eligible recipients, which has positively impacted Moderna's stock price and expanded its market potential for the RSV vaccine, mResvia [1][7]. Group 1: CDC Recommendations - The CDC has revised its recommendations to include adults aged 50-59 at higher risk of severe illness from RSV, advising them to receive a single dose of the vaccine [2][8]. - Previously, the guidance recommended vaccination for individuals aged 75 and older, and those aged 60-74 who were at high risk [2][8]. - The current HHS secretary, Robert F. Kennedy, Jr., officially adopted these recommendations, filling the role of CDC director, which is currently vacant [3]. Group 2: Impact on Moderna - The expanded CDC recommendations increase the addressable market for Moderna's RSV vaccine, mResvia, by including a new segment of eligible patients aged 50-59 [7][8]. - Despite the initial approval of mResvia for individuals aged 60 and older, the FDA recently expanded its label to include high-risk individuals aged 18-59 [9]. - Sales of mResvia have been modest since its commercial launch last year, as it was approved later in the contracting season compared to GSK's and Pfizer's vaccines [9][10]. Group 3: Competitive Landscape - Moderna is competing with GSK and Pfizer, both of which have already received approvals for their RSV vaccines for individuals aged 60 and older, with GSK's Arexvy also approved for high-risk individuals aged 50-59, and Pfizer's Abrysvo approved for high-risk individuals aged 18-59 [11]. - The earlier availability of GSK and Pfizer's vaccines has given them a dominant position in the market over Moderna [10]. Group 4: Stock Performance - Year to date, Moderna's stock has lost 27%, while the industry has only seen a 2% decline [5].
mRNA巨头亏损背后,中国药企能否接棒下一个增长极
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-01 04:53
21世纪经济报道记者 韩利明 上海报道 从传统小分子到小分子靶向药物,再逐步拓展至大分子、细胞疗法与mRNA疗法,生物医药领域的每一 次研发突破都在为临床诊疗拓宽路径。其中,mRNA技术在新冠疫情期间通过疫苗研发迅速完成商业化 验证,Moderna、BioNTech和CureVac借此成长为全球mRNA巨头。然而,随着疫情影响消退,mRNA行 业也步入转型关键期。 在技术应用层面,麦高证券研报指出,mRNA肿瘤疫苗有望成为一种适用于泛癌种、具备高可及性、能 够实现现货化与个性化兼具的新型肿瘤免疫疗法。通过广泛的联合应用,以辅助疗法作为切入点,该疫 苗有望逐步释放出数百亿美金的市场潜力。 在企业战略布局上,特别是进入2025年,行业巨头动作频频。其中,BioNTech通过战略收购布局 ADC、PD(L)1/VEGF双抗等热门肿瘤管线之余,更是在今年 6月斥资12.5亿美元收购CureVac,强化其在 研mRNA癌症免疫疗法的全链条能力。而全力押注mRNA技术的Moderna,也呈现出喜忧参半的发展态 势。 与此同时,大洋彼岸的中国正处于创新药物爆发期,mRNA赛道呈现出冰火两重天的格局。既有明星药 企黯然退场, ...
EMA Accepts GSK's Filing for Expanded Use of RSV Vaccine Arexvy
ZACKS· 2025-06-16 16:20
Key Takeaways GSK's Arexvy may be approved in Europe for adults 18 following EMA's acceptance of its application. The RSV vaccine is currently cleared for adults 60 and high-risk individuals aged 50-59 years. Arexvy sales fell 57% in the first quarter of 2025 due to lower demand in the United States.GSK plc (GSK) announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vacci ...
Moderna(MRNA.US)RSV疫苗覆盖群体扩容 FDA批准扩至60岁以下成年人
智通财经网· 2025-06-13 04:23
智通财经APP获悉,美国监管机构已批准mRNA疫苗领域领军者Moderna(MRNA.US)旗下的一款疫苗产 品用于预防更多成年人群体罹患常见呼吸道疾病,这可能显示出特朗普政府对于mRNA疫苗技术的抵制 有所缓和。此项批准将帮助 Moderna 瞄准更大规模市场,因为其竞争对手辉瑞已获准向60岁以下高风 险人群出售其RSV疫苗,葛兰素史克已获准向50至59岁高风险人群出售RSV疫苗。 Moderna 在一份声明中表示,该公司可向60岁以下、感染呼吸道合胞病毒(RSV)风险较高的成年人销售 这款疫苗产品。据了解,美国食品药品监督管理局(FDA)去年已批准该疫苗用于60岁及以上人群,这也 意味着为Moderna在其mRNA新冠疫苗之后带来了第二款mRNA疫苗产品。 自那以后,Moderna 的RSV疫苗产品一直难以获得广泛采用。此次针对更年轻成人的新增批准,将帮助 该公司面向更大规模的疫苗市场。其竞争对手辉瑞公司(PFE.US)此前已获准向60岁以下高风险患病人群 出售RSV疫苗;另一RSV疫苗竞争对手葛兰素史克公司也已获准向50至59岁这一范围的高风险人群销售 RSV疫苗产品。 今年4月,美国FDA关键顾问小组 ...
Moderna Secures FDA Nod for Next-Gen COVID-19 Vaccine mNexspike
ZACKS· 2025-06-03 17:21
Key Takeaways Moderna received FDA approval for mNexspike, its next-gen COVID-19 vaccine with limited use criteria. Vaccine is cleared for older adults and high-risk individuals aged 12-64, not the broader group MRNA wanted. The vaccine offers a better shelf life and matched or outperformed Spikevax in late-stage trial data.Moderna (MRNA) announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a label narrower than initially targeted. The vaccine will ...
1 Beaten-Down Stock to Buy Right Now, and 1 to Avoid
The Motley Fool· 2025-05-16 09:30
Equity markets are full of bargains -- stocks that have performed terribly in recent months, whether due to trade-related marketwide issues or company-specific troubles, but could bounce back once things improve. There are also companies that are not performing well and are unlikely to rebound anytime soon; that's the kind investors should stay away from.Let's consider one stock in each category: Moderna (MRNA -1.50%), a beaten-down stock with decent prospects, and Teladoc Health (TDOC -1.02%), one whose fu ...
Moderna Sharpens Pipeline Focus as COVID-19 Vaccine Demand Ebbs in Q1
ZACKS· 2025-05-06 14:55
Moderna (MRNA) kicked off 2025 with mixed first-quarter results. While its streamlining efforts improved bottom-line numbers, the steep decline in revenues raises concerns.While sales of its COVID-19 vaccine continue to decline as expected in a post-pandemic market, Moderna is taking proactive steps to reshape its future. The company is swiftly advancing multiple pipeline candidates across late-stage development, with the intent to diversify its existing revenue base and launch multiple new products over th ...
Moderna Expands Cost-Cutting Program By Up To $1.7 Billion, FDA Approval For Flu/COVID-19 Combo Shot Delayed Into 2026
Benzinga· 2025-05-01 17:14
Moderna Inc. MRNA reported on Thursday a first-quarter EPS loss of $(2.52), missing the consensus of $(3.12), down from an EPS loss of $(3.07) a year ago.The COVID-19 vaccine maker reported quarterly sales of $108 million, down from $167 billion a year ago, beating the consensus of $106.20 million.The decline was primarily driven by lower net product sales, which totaled $86 million in the quarter.The reduction in product sales reflects lower vaccination rates compared to the same period last year and the c ...
Moderna Beats on Q1 Earnings, Lags on Revenues, Focuses on Cost Cuts
ZACKS· 2025-05-01 16:26
Moderna (MRNA) incurred a loss of $2.52 per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $2.92. In the year-ago period, the company had reported a loss of $3.07.Total revenues in the quarter were $108 million, which missed the Zacks Consensus Estimate of $127 million. Revenues declined around 35% year over year, owing to lower net product sales. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)More on MRNA’s Q1 EarningsModerna currently ...
Moderna(MRNA) - 2025 Q1 - Earnings Call Presentation
2025-05-01 11:16
© 2025 Moderna, Inc. All rights reserved. Forward-looking statements and disclaimer First Quarter 2025 Financial Results May 1, 2025 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's ability to drive use of Spikevax and mRESVIA and expand markets for its products; Moderna's 2025 financial framework; Moderna's ability to deliver cost efficiency across the business, including a ...