Financial Performance - In 2025, the company achieved total revenue of $1.9 billion, primarily from sales of its COVID vaccines[22]. - The company expects to drive revenue growth in 2026 from long-term partnerships in the UK, Canada, and Australia, along with strong uptake of mNEXSPIKE in the U.S.[37]. Product Development and Clinical Trials - The company is advancing a pipeline of development candidates across oncology, rare disease, and infectious disease, with eight Phase 2 and Phase 3 clinical trials underway for intismeran[23]. - The company has a diverse development pipeline consisting of 35 therapeutic and vaccine programs, with 6 in late-stage development[58]. - The company continues to advance its early-stage pipeline, including oncology programs and multiple early-stage vaccine programs[38]. - The company anticipates pivotal trial data readouts in 2026 across its oncology, rare disease, and infectious disease portfolios, with plans to launch several new infectious disease products[37]. - The Phase 3 trial for mRNA-1018 is expected to begin in early 2026, following CEPI's investment[78]. - The Phase 3 trial of the trivalent vaccine candidate mRNA-1403 has enrolled about 38,000 participants, focusing on older adults who are at the highest risk of severe outcomes[95]. - The ongoing Phase 1/2 study of mRNA-4349 includes cohorts for first-line metastatic melanoma and first-line metastatic NSCLC[122]. - The registrational study for mRNA-3927 has reached target enrollment, and an infant dose-finding study is also ongoing[131]. Regulatory Approvals - The company has regulatory filings under review for its seasonal flu+COVID combination vaccine candidate (mRNA-1083) and expects a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026, for mRNA-1010[24]. - The FDA has approved the 2025-2026 Spikevax formula for high-risk individuals aged six months through 64 years and all adults 65 years and older, with approvals received in 40 countries[64]. - The RSV vaccine (mRNA-1345 or mRESVIA) has been approved for adults 60 years and older, with recommendations for unvaccinated individuals aged 75 and older and high-risk individuals aged 50-74[66]. - The FDA accepted the BLA for mRNA-1010 for review, with a PDUFA goal date of August 5, 2026[71]. Manufacturing and Production - The company streamlined its production sites into a global manufacturing network, adding three facilities in the UK, Canada, and Australia to enhance local access to mRNA vaccines[26]. - The Marlborough biomanufacturing facility, completed in 2025, is designed for speed and scalability, and began shipping patient batches in September 2025[141]. - mRNA manufacturing facilities in the UK, Canada, and Australia were fully licensed in 2025, with multi-year commitments from local governments to purchase mRNA products[142]. - The company has invested significantly in manufacturing process science to produce mRNA medicines at scales ranging from micrograms to kilograms[52]. Strategic Collaborations - The company entered into a strategic collaboration with Recordati to advance its propionic acidemia therapeutic (mRNA-3927) through final stages of clinical development[25]. - Moderna's strategic alliance with Merck for personalized mRNA cancer vaccines includes an upfront payment of $200 million and a subsequent option exercise fee of $250 million[178][179]. - The collaboration with BARDA for the development of mRNA-1273, the original COVID vaccine, had a maximum award of approximately $1.8 billion, concluding on June 15, 2025[183]. - The company has entered into a collaboration with Recordati to advance investigational PA therapeutic (mRNA-3927) through clinical development and commercialization[182]. Intellectual Property - Moderna's intellectual property estate includes over 260 issued or allowed U.S. patents and more than 140 granted patents outside the U.S., with most patents not expiring until at least 2033[189]. - The projected expiration for U.S. patents covering the company's approved products, such as Spikevax and mNEXSPIKE, is 2041, while European patents are set to expire in 2036[198]. - The company maintains a multi-program effort to develop vaccines for potential future pandemics, targeting diseases such as Zika, dengue, HIV, and Nipah virus[206]. - The company's trademark portfolio includes at least 1,400 registrations and 180 pending applications across more than 55 jurisdictions[214]. Research and Innovation - The company has implemented AI-driven data analytics to optimize drug design, clinical trial operations, and manufacturing processes, enhancing efficiency and product quality[164][165][166]. - In early 2023, Moderna began a collaboration with OpenAI to integrate AI capabilities across various business functions, including legal, research, and manufacturing[167]. - The company is focused on expanding its modalities, which allows for rapid acceleration of programs based on learnings from earlier initiatives[56]. Economic Impact - Norovirus causes an estimated 685 million illnesses and 200,000 deaths annually, with a significant economic impact of approximately $60 billion per year globally[90]. - The economic burden of norovirus in the U.S. is estimated at $2 billion annually, with 20 million infections and 100,000 hospitalizations each year[90].

Core Insights - The biotech industry experienced significant developments this week, including FDA approvals, clinical trial results, and licensing agreements, indicating a dynamic landscape for investment opportunities and advancements in healthcare [1]. FDA Approvals & Rejections - NRx Pharmaceuticals is on track for FDA approval of NRX-100, with existing clinical data and real-world evidence from over 65,000 patients potentially supporting a New Drug Application (NDA) under Fast Track Designation [2][3]. - Kane Biotech received FDA clearance for its Revyve Antimicrobial Skin and Wound Cleanser, which targets wound bacteria and biofilms, with plans for manufacturing scale-up in 2026 [4][5]. - Johnson & Johnson's RYBREVANT FASPRO received FDA approval for a simplified monthly dosing schedule, enhancing treatment options for patients with advanced non-small cell lung cancer [6][7]. - Spruce Biosciences reported positive feedback from FDA Type B meetings for its enzyme replacement therapy for Sanfilippo syndrome type B, with a targeted BLA filing in Q4 2026 [8][9]. - Moderna's seasonal influenza vaccine submission (mRNA-1010) is under FDA review, with a PDUFA date set for August 5, 2026, aiming for availability in the 2026/2027 flu season [10][11]. - Disc Medicine received a Complete Response Letter (CRL) for its NDA for Biopertin in erythropoietic protoporphyria, citing insufficient correlation with sunlight exposure endpoints [13][14]. - AbbVie and Genentech's combination regimen of VENCLEXTA and Acalabrutinib for chronic lymphocytic leukemia (CLL) received FDA approval, showing a 35% reduction in disease progression risk compared to standard treatment [15][16]. Deals - Theriva Biologics entered an exclusive licensing agreement with Rasayana Therapeutics for SYN-020, receiving a $3 million upfront payment and potential milestone payments totaling up to $38 million [17][18]. - Sensei Biotherapeutics acquired Faeth Therapeutics, expanding its oncology portfolio with the investigational asset PIKTOR, and announced a concurrent private placement of $200 million to advance clinical milestones [19][20]. Clinical Trials - Breakthroughs - Eli Lilly's Taltz and Zepbound combination therapy showed positive results in a Phase 3 trial for plaque psoriasis and obesity, achieving superior outcomes compared to Taltz alone [21][22]. - Zealand Pharma reported positive Phase 1a results for ZP9830, a Kv1.3 channel blocker, demonstrating safety and tolerability in healthy volunteers [23][24]. - Novartis' Remibrutinib met primary endpoints in a Phase 3 trial for chronic inducible urticaria, showing significant response rates compared to placebo [26][27]. - Ocular Therapeutix's AXPAXLI demonstrated superiority over aflibercept in a Phase 3 trial for wet age-related macular degeneration, although stock prices fell due to investor disappointment [28][29]. - Rallybio's RLYB116 Phase 1 study showed promising results for immune platelet transfusion refractoriness, with plans for a Phase 2 trial in 2026 [31][32]. - Teva and Sanofi's Duvakitug Phase 2b trial demonstrated durable efficacy in ulcerative colitis and Crohn's disease, reinforcing the rationale for ongoing Phase 3 programs [35][36]. - Genentech's Gazyva met primary endpoints in a Phase III study for primary membranous nephropathy, showing significant remission rates compared to tacrolimus [38][39].

U.S. Food and Drug Administration (FDA) Commissioner Marty Makary holds up a study from The Lancet during an announcement of the FDA’s intent to phase out the use of petroleum-based synthetic dyes in the nation’s food supply during a press conference at the Department of Health and Human Services in Washington, D.C., U.S., April 22, 2025. REUTERS/Elizabeth FrantzElizabeth Frantz | ReutersA version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest health-care news s ...

Core Viewpoint - BioNTech has initiated a lawsuit against Moderna in Delaware federal court, claiming that Moderna's COVID-19 vaccine, mNexspike, infringes on a patent related to BioNTech and Pfizer's vaccine, Comirnaty [1]. Company Summary - BioNTech is asserting its intellectual property rights in the biopharmaceutical sector by targeting Moderna for alleged patent infringement [1]. - Moderna's mNexspike vaccine is at the center of the legal dispute, indicating potential competitive tensions in the COVID-19 vaccine market [1]. Industry Context - The lawsuit highlights ongoing legal battles within the biopharmaceutical industry, particularly concerning vaccine patents and intellectual property rights amid the COVID-19 pandemic [1].

Core Viewpoint - Moderna's shares increased by 6% following the FDA's decision to review its regulatory filing for the seasonal influenza vaccine, mRNA-1010, with a final decision expected by August 5, 2026 [1][8]. Group 1: Regulatory Developments - The FDA had previously refused to review the mRNA-1010 filing, citing inadequacies in the late-stage study that compared it to a standard-dose influenza vaccine [2]. - Moderna has modified its regulatory filing to seek full approval for adults aged 50-64 and accelerated approval for those aged 65 and above [2][4]. - The filing is supported by data from multiple late-stage studies demonstrating that mRNA-1010 generates immune responses comparable to existing flu vaccines from GSK and Sanofi [4]. Group 2: Market Implications - If approved, Moderna plans to commercially launch mRNA-1010 for the 2026/2027 vaccination season and will conduct additional studies for older adults as part of post-marketing requirements [3]. - The FDA's reversal is seen as a significant step in expanding Moderna's product portfolio beyond its COVID-19 vaccine and RSV vaccine [5]. Group 3: Future Prospects - The recent developments have also raised optimism for mRNA-1083, a combination vaccine for COVID-19 and influenza, which is awaiting further guidance from the FDA [6]. - Year-to-date, Moderna's stock has increased by 58%, significantly outperforming the industry growth of 9% [7].

CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 19, 2026 / Moderna, Inc. (Nasdaq:MRNA), today announced its participation in the following upcoming investor conferences: TD Cowen 46th Annual Healthcare Conference, on Tuesday, March 3rd at 1:50pm ET Barclays 28th Annual Global Healthcare Conference, on Tuesday, March 10th at 9:30am ET A live webcast of each of these presentations will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.co ...

Carvana (CVNA) - Carvana sold more cars than Wall Street expected in Q4, but concerns over profitability led to a 16% drop in premarket trading [5] - The company experienced a 58% surge in revenue, with retail vehicle sales up 43% and wholesale sales increasing by 66% [5] - However, gross profit per vehicle declined by $244, and adjusted EBITDA of $511 million missed estimates of $539 million [6] - Adjusted profits per share surged to $4.22 from $0.56, but this was attributed to one-time charges and is not comparable to the $1.12 estimates [6] - Carvana did not issue sales guidance for the full year but expects to sell 3 million cars between 2030 and 2035 [7] DoorDash (DASH) - DoorDash shares rose 13% in premarket trading due to strong order growth and upbeat guidance, despite a Q4 miss on both top and bottom lines [7] - Orders climbed 32% to 903 million, and gross order value (GOV) jumped 39% to $29.7 billion, both exceeding expectations [7] - The Q1 outlook for GOV is projected between $31 billion and $31.8 billion, with EBITDA expected to be between $675 million and $775 million [7] Moderna (MRNA) - Moderna shares closed 6% higher after the FDA accepted its marketing application for the mRNA-1010 flu shot, reversing a previous refusal to review [8] - The FDA has set August 5, 2026, as the target action date for the biologics license application (BLA) for mRNA-1010 [9] - Moderna plans to launch mRNA-1010 in the U.S. for adults aged 50 and older for the 2026/2027 flu season [10]

Moderna (MRNA) stock closed higher on Wednesday after the FDA reversed its earlier refusal-to-file decision on the company’s mRNA-1010 seasonal influenza vaccine. As the regulatory agency agreed to review MRNA’s revised application, its stock price rallied past its 20-day moving average (MA), signaling bullish momentum could sustain in the near term. More News from Barchart Despite today’s surge, Moderna stock remains down some 15% versus its year-to-date high. www.barchart.com Moderna Stock Remains ...

经济观察网 根据2026年2月19日的公开信息，莫德纳（MRNA）采用mRNA技术的流感疫苗上市申请已 获得美国食品药品监督管理局（FDA）受理，审批截止日期定于2026年8月1日。FDA此前于2月10日以 临床试验设计存在缺陷为由拒绝受理该申请，但在后续沟通后改变立场，同意启动审核流程。莫德纳为 加速获批已提出分年龄段的监管路径：为50至64岁人群寻求常规批准，为65岁及以上人群寻求加速批 准，并承诺上市后在老年人群中开展追加研究。若获批，该疫苗计划在2026年晚些时候的流感季面向老 年人群使用。 以上内容基于公开资料整理，不构成投资建议。 ...

Moderna announced the change Wednesday, about a week after revealing that the FDA's vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology. The dispute centred over a 40,000-person clinical trial that concluded Moderna's new vaccine was more effective in adults age 50 and older than one of the standard flu shots used today. In the FDA's rare "refusal to file" letter, vaccine director Dr. Vinay Prasad faulted the trial for not including another brand specifically ...