Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over five years of experience in biotech consulting and has prepared detailed reports on more than 1,000 companies [1]

Core Insights - Moderna Inc. announced the presentation of clinical data for mRNA-4359 in combination with pembrolizumab for CPI-R/R melanoma at the 2025 European Society for Medical Oncology Congress [1] Group 1: Clinical Data - mRNA-4359 is an investigational cancer antigen therapy targeting immune escape pathways PD-L1 and IDO1, aiming to elicit T cell responses to kill tumor cells [2] - The study involved 29 participants receiving the combination therapy at doses of 400 µg (n=14) or 1,000 µg (n=15), administered every three weeks for up to nine doses [2] - The objective response rate (ORR) across evaluable patients was 24%, while the disease control rate (DCR) was 60% [2] Group 2: Efficacy in Specific Patient Population - Among patients with PD-L1+ tumors (TPS≥1%), the ORR was significantly higher at 67% (6 of 9 participants) [3] - The treatment induced peripheral antigen-specific T cell responses and novel T cell receptor clones, with the median duration of response (DOR) not yet reached [3] Group 3: Safety Profile - The combination of mRNA-4359 and pembrolizumab demonstrated a manageable safety profile, with no new immune-related adverse events reported [4] - mRNA-4359 is also being evaluated in ongoing studies as a monotherapy and in combination with pembrolizumab for advanced melanoma and non-small cell lung cancer (NSCLC) [4] Group 4: Additional Developments - Moderna released preliminary immunogenicity data for the 2025-2026 mNEXSPIKE COVID-19 vaccine formula, showing over a 16-fold increase in neutralizing antibodies against the LP.8.1 variant in specific age groups [5] - Following these announcements, MRNA stock rose by 3.54% to $27.78 [5]

Core Insights - Moderna, Inc. has advanced mRNA-4359 into the Phase 2 portion of its ongoing Phase 1/2 trial [1] - Clinical, safety, and translational data from the study will be presented at the 2025 ESMO Congress in Berlin [1] - mRNA-4359 is an investigational cancer antigen therapy targeting immune evasion pathways PD-L1 and IDO1 [1] Company Developments - The trial evaluates mRNA-4359 in combination with pembrolizumab for checkpoint inhibitor-resistant/refractory melanoma patients [1] - The therapy aims to elicit antigen-specific T cell responses to directly kill tumor cells and deplete tumor suppressor cells [1]

周三，Moderna(MRNA.US)股价走高，截至发稿，该股涨超6.7%，报29.17美元。消息面上，美国疾病 控制与预防中心(CDC)公布最新成人与儿童免疫接种计划，首次将新冠疫苗纳入"个体化决策"模式，并 建议幼儿单独接种水痘疫苗，而非与麻疹、腮腺炎及风疹疫苗联合接种。CDC代理主任兼卫生与公共 服务部副部长Jim O'Neill表示，新政策"让知情同意重回医疗实践"。他指出，2022年的普遍接种建议抑 制了医生与患者讨论疫苗风险与收益的空间。新规强调，65岁以下群体中仅高风险人群的新冠疫苗收益 更大，低风险者可与医生共同决定是否接种。 ...

智通财经APP获悉，周三，Moderna(MRNA.US)股价走高，截至发稿，该股涨超6.7%，报29.17美元。消 息面上，美国疾病控制与预防中心(CDC)公布最新成人与儿童免疫接种计划，首次将新冠疫苗纳入"个 体化决策"模式，并建议幼儿单独接种水痘疫苗，而非与麻疹、腮腺炎及风疹疫苗联合接种。CDC代理 主任兼卫生与公共服务部副部长Jim O'Neill表示，新政策"让知情同意重回医疗实践"。他指出，2022年 的普遍接种建议抑制了医生与患者讨论疫苗风险与收益的空间。新规强调，65岁以下群体中仅高风险人 群的新冠疫苗收益更大，低风险者可与医生共同决定是否接种。 ...

1. 技术奠基与早期探索（2010—2019） Moderna成立于2010年， 公司总部位于美国马萨诸塞州 ，专注于解决mRNA技术的核心难题。 "Moderna"这个名称源于"Modified RNA"，精准反映了其技术核心。 本期"一页纸"讲透美股公司系列的主角是美股公司Moderna（MRNA） ，新冠疫苗背后mRNA技术的全球领导者。 Moderna的发展历程 作为全球mRNA技术的领导者，Moderna的发展历程清晰地划分为三个环环相扣的阶段：长达十年的技术奠基、由新冠疫情引爆的商业化奇迹，以及后疫 情时代充满挑战的多元化转型。 期间，公司通过与大型药企的战略合作获取关键资金，其中最具里程碑意义的是2013年与阿斯利康达成合作，获得2.4亿美元的巨额预付款，这在当时极 大地验证了其技术平台的潜力并为其后续研发提供了充足弹药。 2015年，公司首个候选疫苗mRNA-1440进入临床I期，标志着Moderna从纯粹的临床前研究迈向临床验证。 公司创立初期在风险投资机构Flagship Pioneering的支持下以"隐形模式"运作，专注于攻克mRNA技术的底层科学难题。 最终，在尚未有任何产品上市的情 ...

Moderna (MRNA) closed the most recent trading day at $28.38, moving +2.83% from the previous trading session. The stock outperformed the S&P 500, which registered a daily gain of 0.06%. At the same time, the Dow added 0.17%, and the tech-heavy Nasdaq gained 0.39%. The biotechnology company's shares have seen an increase of 14.76% over the last month, surpassing the Medical sector's gain of 5.06% and the S&P 500's gain of 3.94%.Investors will be eagerly watching for the performance of Moderna in its upcoming ...

Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]

From a technical perspective, Moderna (MRNA) is looking like an interesting pick, as it just reached a key level of support. MRNA recently overtook the 50-day moving average, and this suggests a short-term bullish trend.The 50-day simple moving average is one of three major moving averages used by traders and analysts to determine support or resistance levels for a wide range of securities. But the 50-day is considered to be more important because it's the first marker of an up or down trend.MRNA has rallie ...

Core Insights - Moderna, Inc. is recognized as one of the top biotech stocks to invest in, with Brookline Capital Markets maintaining a Buy rating and a price target of $198 as of September 23 [1][3]. Company Overview - Moderna, Inc. is a biotechnology company focused on the discovery, development, and commercialization of mRNA-based medicines and vaccines, gaining significant recognition for its COVID-19 vaccine, one of the first mRNA vaccines delivered globally [4]. Vaccine Performance - The mNEXSPIKE/mRNA-1283 vaccine has shown a remarkable increase in neutralizing antibodies against the LP.8.1 variant, averaging over sixteen times compared to the initial COVID-19 vaccination results, which Brookline described as "remarkably strong" [2]. Sales Projections - Moderna's COVID-19 vaccine sales are projected to reach 10.9 million units in the U.S. this year, a decrease from the expected 14.6 million in 2024. Global sales are anticipated to be $2.1 billion in 2025 and could rise to $15.6 billion by 2030 [3].