Aankondiging • Aug 28

Moderna Receives Fda Approval for Mflusiva, the First Mrna Influenza Vaccine for Adults 50 and Older

Moderna's mFlusiva, the first influenza vaccine to use mRNA technology, was approved by the U.S. Food and Drug Administration for adults 50 and older. Tens of thousands of Americans typically die from the flu every year, and the vast majority of them are 65 and older. The approval gives many older Americans a long-awaited new option for protection. It has long been a public health priority to evolve flu vaccine technology—a process which currently takes more than six months to produce a shot and is prone to mismatches with the circulating strains—so that manufacturers can respond more quickly to the evolving virus, ultimately making flu shots more effective. Regulators in the EU, Canada, and Australia are also reviewing the vaccine, and the European Medicine Agency has separately authorized a combined mRNA COVID-flu vaccine, also by Moderna. The FDA's committee of outside scientists, which reviews data on vaccine safety, effectiveness, and appropriate use, voted unanimously that mFlusiva's benefits outweigh its risks for adults 50 and older. In clinical trials, mFlusiva (mRNA-1010) was about 26.6% more effective at preventing laboratory-confirmed influenza illness than a traditional flu vaccine. It also produced a stronger immune response than traditional vaccines in adults 65 and older, with similar rates of severe side effects—which remained rare. That promising data led to accelerated FDA approval that expedites access to the shot for that high-risk group. The vaccine's safety has been tested in roughly 70,000 people in clinical trials. The 2026-27 flu season will provide the first real-world data on how the vaccine performs in populations that don't typically meet criteria for clinical trials, such as organ transplant recipients, severely immunocompromised people, or people on certain medications. Existing data from mRNA COVID vaccines bodes well for mFlusiva's real-world safety profile. The standard inactivated vaccine—used in most flu shots—is grown from flu viruses in eggs, a technology that's been in use for 80 years. The virus is grown, then killed, then made into a vaccine—a process that takes months, meaning scientists must predict as early as January or February which strain will be circulating in the fall, more than six months later. The other traditional platform is recombinant/subunit protein vaccines, which contain pieces of the flu pathogen that company immune systems learn to recognize and defend against. This method can produce vaccines faster than the egg-based process but is more expensive. Rather than growing a virus or isolating proteins, mRNA vaccines deliver a short genetic script that instructs the body's own cells to produce a piece of the flu virus, training the immune system to recognize it. Because that script can be rewritten and swapped out quickly—without growing anything in eggs or cell culture—it is the fastest process, biologically, for updating a vaccine. The speediness—how fast one can make an mRNA vaccine—is really helpful for things like flu and COVID, where the virus changes over time. This technology lends itself to being able to move more quickly and pivot to give a vaccine that may be a better match for the upcoming flu season. If one has a vaccine that one can start making in August and have it ready for September, it can be a better match for the strain that's actually circulating. The U.S. and many other countries have the infrastructure to quickly produce and adapt mRNA flu shots as needed, thanks to rapid vaccine development in response to the COVID pandemic. The new shot will be an option for many older adults this year—but it's unclear how widely available it will be or how many Americans will choose it. FDA approval typically means that health insurance will cover the vaccine, but it may not be stocked in every pharmacy. Traditional flu shots—already formulated for this season—will remain widely available. It's also unclear how much of the vaccine Moderna will manufacture and what price it will set. Uptake is another open question. Moderna may opt for a relatively small initial rollout to gauge interest and to run more studies comparing the vaccine's effectiveness against traditional flu shots. Other flu shots aren't going anywhere this season. They will still be an option for older Americans, and it could be years before mRNA shots are approved for younger Americans—a process that requires separate clinical trials. Longer term, the effectiveness in real-world, post-licensure data could shape what happens to older vaccine development processes. Typically, the CDC's Advisory Committee on Immunization Practices compares available vaccines, and if one is clearly more effective with no added safety concerns, it becomes the recommended option. In 2018, Shingrix became the CDC's recommended shingles vaccine after it proved significantly more effective than its predecessor, Zostavax, which was later discontinued and pulled from the U.S. market in 2020. Something similar could eventually happen with flu vaccines, but resistance to mRNA technology could complicate that decision.

Aankondiging • Aug 20

Merck & Co., Inc. And Moderna, Inc. Announce Phase 3 INTerpath-001 Trial Of Intismeran Autogene Plus KEYTRUDA Met Endpoints Of Recurrence-Free Survival And Distant Metastasis-Free Survival In Patients With Completely Resected Stage IIB-IV Melanoma

Merck & Co., Inc. and Moderna, Inc. announced positive topline results from the Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran autogene (intismeran; V940 or mRNA-4157), a novel investigational mRNA-based individualized neoantigen therapy (INT) being jointly developed by Merck and Moderna, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma. The trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). This represents the first positive Phase 3 readout for an individualized neoantigen therapy (INT) and for an mRNA-based cancer therapy, as well as the first Phase 3 study to demonstrate a clinically meaningful improvement over KEYTRUDA alone, a standard-of-care immunotherapy, in the adjuvant setting for patients with resected melanoma. At a pre-specified interim analysis, intismeran in combination with KEYTRUDA as adjuvant therapy demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared to KEYTRUDA alone for patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not undergone prior treatment with systemic therapy. In accordance with the trial protocol, the study will continue in order to evaluate other key secondary endpoints, including overall survival (OS). The safety profiles of intismeran and KEYTRUDA in this trial were consistent with those observed in previously reported studies for the combination, with no new safety signals observed. Intismeran autogene is an mRNA-based individualized neoantigen therapy (INT) designed specifically for each patient based on the unique set of mutations within their tumor to train and activate the immune system to recognize and fight cancer. Intismeran is designed and produced using a patient's tumor sample to identify the unique mutational signature, or 'fingerprint,' of their cancer and generate an anti-tumor immune response. Each therapy consists of a synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient's tumor. Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells. Individualized neoantigen therapies are designed to train and activate an anti-tumor immune response based on the unique mutational signature of a patient's tumor. INTerpath-001 is a randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 trial evaluating the safety and efficacy of intismeran in combination with KEYTRUDA compared to KEYTRUDA alone in patients with high-risk (stage IIB-IV) resected cutaneous melanoma. The trial enrolled 1,137 patients who, following complete surgical resection, were randomized 2:1 to receive intismeran (1 mg every three weeks for up to nine doses) and KEYTRUDA (400 mg every six weeks up to nine cycles [for approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever was sooner. The primary endpoint is RFS, defined as the time from randomization to any disease recurrence (local, locoregional, regional or distant) as assessed by the investigator, or death due to any cause. Key secondary endpoints include DMFS, OS, safety, tolerability and quality of life. The INTerpath program currently consists of nine total Phase 2 and Phase 3 clinical trials across multiple tumor types and stages of disease, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. Additional clinical studies include the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial in adjuvant melanoma and a Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma and perioperative NSCLC. Previously reported Phase 2b results for intismeran in combination with KEYTRUDA from the KEYNOTE-942/mRNA-4157-P201 trial, including the five-year follow-up data presented at the 2026 ASCO Annual Meeting, in which the combination demonstrated a 49% reduction in the risk of recurrence or death (HR=0.51; [95% CI, 0.294-0.887]) and a 59% reduction in the risk of distant metastasis or death (HR=0.411; [95% CI, 0.200-0.843]) compared to KEYTRUDA alone.

Totaal aandeelhoudersrendement	-0.1%
Toekomstig dividendrendement	0%
Dividendgroei	n/a
Volgende betaaldatum dividend	n/a
Ex-dividenddatum	n/a
Dividend per aandeel	n/a
Uitbetalingsratio	n/a

Segment	Dividendrendement
Bedrijf (MRNA)	n/a
Markt onderkant 25% (US)	1.4%
Markt Top 25% (US)	4.1%
Gemiddelde industrie (Biotechs)	2.2%
Analist prognose (MRNA) (tot 3 jaar)	0%

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/09/13 02:00
Aandelenkoers aan het einde van de dag	2026/09/11 00:00
Inkomsten	2026/06/30
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
null null	Argus Research Company
Eliana Merle	Barclays
Huidong Wang	Barclays

Moderna Dividenden en inkoop

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Recente updates van dividend en inkoop

Recent updates

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Merck & Co., Inc. And Moderna, Inc. Announce Phase 3 INTerpath-001 Trial Of Intismeran Autogene Plus KEYTRUDA Met Endpoints Of Recurrence-Free Survival And Distant Metastasis-Free Survival In Patients With Completely Resected Stage IIB-IV Melanoma

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