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 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 ...

The stock’s movement comes after the U.S. Food and Drug Administration (FDA) notified Moderna that its biologics license application for mRNA-1010 will proceed to review, adding pressure as broader markets experienced mixed trading.Following a Type A meeting, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5 for mRNA-1010, which is aimed at adults aged 50 and older.Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, inclu ...

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, ...

Core Viewpoint - The FDA has agreed to review Moderna's experimental mRNA flu shot, reversing its earlier decision, which has surprised both Wall Street and the medical community [1][2]. Group 1: FDA Review and Approval Process - The FDA is expected to make a decision on the flu shot by August 5, which is crucial for Moderna's plans to introduce the vaccine for the upcoming influenza season [2]. - Moderna aims for full approval of the flu shot for adults aged 50 to 64 and accelerated approval for those aged 65 and older, which will require a post-marketing study to confirm benefits [5]. - The FDA's acceptance of the modified application follows a "constructive" meeting where Moderna proposed a revised regulatory approach addressing previous criticisms [4][5]. Group 2: Clinical Trial and Regulatory Concerns - The FDA had previously criticized Moderna's choice of comparator in its phase three trial, stating it did not reflect the best standard of care in the U.S. [6]. - Moderna contends that FDA guidelines do not mandate the use of the highest-dose vaccine as a comparator and argues that the agency's prior communications supported their trial design [8]. - The decision to initially refuse the application was influenced by the FDA's top vaccine regulator, who has advocated for stricter vaccine regulations [9][10]. Group 3: Market Reaction and Company Outlook - Following the announcement of the FDA's review, shares of Moderna increased by over 6% [3]. - The successful introduction of the flu vaccine is integral to Moderna's goal of achieving financial break-even by 2028 [2].

Moderna's stock was surging after the FDA said it would review the biotech's flu-vaccine candidate, a week after it had refused to do so. ...

Pharma giant Moderna Inc (NASDAQ:MRNA) is enjoying a boost today, after the U.S. Food & Drug Administration (FDA) accepted the company's flu vaccine application for review. The company made modifications to the application after it was rejected last week. MRNA was last seen up 5.7% to trade at $46.45, heading for a third-straight gain as it moves back toward its Jan. 22 more than one-year high of $55.20. Since the start of the year, the equity is already up 55.4%. A bout of short covering could help push Mo ...

The Food and Drug Administration has reversed its decision not to review a new flu vaccine from Moderna, the pharmaceutical company said Wednesday.Last week, the FDA sent a missive to Moderna refusing to review its new shot, saying its application did not contain adequate research – leaving the company’s president Dr. Stephen Hoge in “complete shock.”Moderna’s flu vaccine will not be reviewed by the FDA. Rawf8 – stock.adobe.comIn an exclusive interview with The Post, Hoge said he was “completely surprised a ...

The U.S. Food and Drug Administration will review the investigational seasonal flu vaccine candidate after rejecting it earlier this month. ...