Anuncio • 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.

Anuncio • 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.

Rendimiento total para el accionista	-0.1%
Rendimiento futuro de los dividendos	0%
Crecimiento de los dividendos	n/a
Próxima fecha de pago de dividendos	n/a
Fecha ex dividendo	n/a
Dividendo por acción	n/a
Ratio de pago	n/a

Segmento	Rentabilidad por dividendo
Empresa (MRNA)	n/a
Suelo de mercado 25% (US)	1.4%
Techo de mercado 25% (US)	4.1%
Media de la industria (Biotechs)	2.2%
Analista de previsiones (MRNA) (hasta 3 años)	0%

Datos	Última actualización (huso horario UTC)
Análisis de la empresa	2026/09/13 02:00
Precio de las acciones al final del día	2026/09/11 00:00
Beneficios	2026/06/30
Ingresos anuales	2025/12/31

Paquete	Datos	Marco temporal	Ejemplo Fuente EE.UU. ^*
Finanzas de la empresa	10 años	Cuenta de resultados Estado de tesorería Balance	Formulario SEC 10-K Formulario SEC 10-Q
Estimaciones del consenso de analistas	+3 años	Previsiones financieras Objetivos de precios de los analistas	Informes de análisis Blue Matrix
Precios de mercado	30 años	Precios de las acciones Dividendos, escisiones y acciones	Datos de mercado ICE Formulario S-1 de la SEC
Propiedad	10 años	Accionistas principales Información privilegiada	Formulario SEC 4 Formulario SEC 13D
Gestión	10 años	Equipo directivo Consejo de Administración	Formulario SEC 10-K Formulario SEC DEF 14A
Principales avances	10 años	Anuncios de empresas	Formulario SEC 8-K

Analista	Institución
null null	Argus Research Company
Eliana Merle	Barclays
Huidong Wang	Barclays

Moderna Dividendos y recompras

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Información clave

Últimas actualizaciones de dividendos y recompras

Recent updates

Chief Financial Officer notifies of intention to sell stock

MRNA: Melanoma Vaccine Euphoria Will Likely Outrun Realistic Commercial Uptake

Price target increased by 9.3% to US$117

Moderna Begins Phase 3 Trial for mRNA Bird Flu Vaccine Candidate mRNA-1018

Moderna: Massive Asymmetry About What The mRNA Is!

Moderna Wins FDA Approval for New COVID-19 Vaccines Targeting 2026-2027 Variant

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

Moderna Announces $2 Billion Convertible Notes Offering to Advance mRNA Cancer Vaccine Program

MRNA: Future Upside Will Hinge On Melanoma Cancer Vaccine Breakthrough

Moderna Reports Landmark Phase 3 Success for Personalized mRNA Melanoma Vaccine

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

Price target increased by 20% to US$59.11

MRNA: Future Upside Will Hinge On New Flu Vaccine Rollout

New minor risk - Share price stability

Moderna Launches Canadian Trial for mRNA Ebola Vaccine With CEPI Backing

CEO & Director notifies of intention to sell stock

Health Canada Authorizes Moderna To Move Forward With Phase I Clinical Trial For Candidate Mrna Vaccine For Ebola Disease Caused By The Bundibugyo Virus

Second quarter 2026 earnings: EPS and revenues exceed analyst expectations

Moderna Beats Q2 Forecasts as Norovirus Stumbles and Flu Vaccine Faces FDA Decision

MRNA: Flu Revenue Delays And Regulatory Timing Will Constrain Future Upside

Price target increased by 7.7% to US$49.37

Moderna Begins Dosing in First Human Trial for Tumor-Targeted mRNA Cancer Therapy

President notifies of intention to sell stock

MRNA: Flu Approval Uncertainty And Delayed Vaccine Revenues Will Restrain Upside

Moderna Wins Four-Year EU Supply Deal for RSV Vaccine and Names New Commercial Chief

Moderna, Inc. Announces Board and Committee Changes, Effective July 8, 2026

Price target increased by 9.5% to US$47.58

FDA Panel Backs Moderna mRNA Flu Vaccine as Company Expands Cancer and Autoimmune Pipeline

MRNA: Flu Approval Progress Will Still Limit Long Term Upside

FDA Panel Backs Moderna mRNA Flu Vaccine for Adults 50 and Older

Moderna Receives Unanimous FDA Panel Recommendation for mRNA-Based Influenza Vaccine for Adults 50 and Older

Moderna (MRNA) Stock Could Be 39% Overvalued After FDA Flu Vaccine Backing

Moderna Shares Climb as FDA mFlusiva Review Nears and Multiple Vaccine Launches Planned

Moderna Plans Multiple Product Launches in 2027 and 2028

President notifies of intention to sell stock

MRNA: Flu Review And Pipeline Execution Risk Are Expected To Restrain Upside

Moderna Reports Strong Five-Year Melanoma Vaccine Data and Expands Ebola Program with CEPI Funding

MRNA: Flu Review And Litigation Overhang Will Continue To Restrain Upside

President notifies of intention to sell stock

MRNA: Future Upside Will Depend On Upcoming Flu Vaccine Authorization Outcome

First quarter 2026 earnings: EPS and revenues exceed analyst expectations

Price target decreased by 8.3% to US$41.42

Consensus EPS estimates fall by 10%

MRNA: Litigation Tail And Uncertain Flu Path Will Limit Long-Term Upside

Moderna, Inc. to Report Q1, 2026 Results on May 01, 2026

MRNA: Flu Review Uncertainty And Legal Tail Risk Will Constrain Upside

MRNA: Litigation Deal And Flu Review Path Will Limit Future Upside

Moderna, Inc., Annual General Meeting, May 06, 2026

MRNA: Litigation Settlement And Flu Setback Will Constrain Future Upside

Genevant Sciences and Arbutus Biopharma Announce $2.25 Billion Global Settlement with Moderna

MRNA: Future Upside Will Hinge On Upcoming Flu Vaccine Approval Decision

President notifies of intention to sell stock

Price target increased by 7.2% to US$41.60

Moderna, Inc. (NASDAQ:MRNA) Released Earnings Last Week And Analysts Lifted Their Price Target To US$40.90

MRNA: Future Upside Will Depend On Vaccine Pipeline Execution Outcomes

Full year 2025 earnings: EPS and revenues exceed analyst expectations

Moderna, Inc. Receives Refusal-To-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, Mrna-1010

Arbutus Biopharma Corporation Announces Court Ruling on Patent Infringement Dispute over Lipid Nanoparticle Vaccine Technology

Now 20% overvalued after recent price rise

Moderna, Inc.'s (NASDAQ:MRNA) Price Is Right But Growth Is Lacking After Shares Rocket 43%

MRNA: Cancer Vaccine Risk And Vaccine Backlash Will Restrain Long-Term Upside

Moderna, Inc. Announces Executive and Committee Changes, Effective March 2, 2026

Moderna, Inc. to Report Q4, 2025 Results on Feb 13, 2026

MRNA: Late Stage Vaccine Outcomes Will Define Future Upside Potential

New minor risk - Share price stability

MRNA: Oncology Progress Will Drive Long-Term Upside Despite Debt And Litigation

MRNA: Oncology Advances And Buyout Optionality Will Offset Debt And Litigation Risks

There's No Escaping Moderna, Inc.'s (NASDAQ:MRNA) Muted Revenues Despite A 28% Share Price Rise

CEO & Director exercised options to buy US$21m worth of stock.

Insider exercised options and sold US$582k worth of stock

Insider exercised options and sold US$582k worth of stock

MRNA: Oncology Pipeline Progress Will Drive Long Term Upside Despite Litigation Risk

Price target decreased by 10% to US$35.78

MRNA: Oncology Pipeline Advances Will Drive Renewed Optimism Despite Regulatory Shifts

Consensus estimates of losses per share improve by 18%