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Moderna

PublicFounded 2010🇺🇸Cambridge, Massachusetts
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CEO

Stéphane Bancel

Data verified as of Sep 1, 2026

Summary

Moderna is the pioneer and, with BioNTech, one of the two global leaders in messenger-RNA (mRNA) medicine. Founded in 2010 and incubated by Flagship Pioneering, it rose to prominence with Spikevax, its COVID-19 vaccine that reached full FDA approval in 2022 and drove roughly $18B of revenue at its 2022 peak. Moderna is now navigating a steep post-COVID transition: FY2025 revenue fell ~40% to $1.9B and it posted a $2.8B net loss, prompting ~$2.2B of annual cost cuts and a 10% workforce reduction. The company is rebuilding around a four-product respiratory franchise - next-gen COVID vaccine mNEXSPIKE, RSV vaccine mRESVIA, Europe's first flu+COVID combination mCOMBRIAX, and, as of its August 5, 2026 FDA approval, mFlusiva, the first mRNA-based flu vaccine - while its highest-value bet is intismeran autogene (mRNA-4157/V940), an individualized neoantigen cancer therapy partnered with Merck that has shown durable five-year benefit in melanoma and, as of August 19, 2026, met both endpoints of its pivotal Phase 3 melanoma trial, with a regulatory filing planned within months. Its first rare-disease candidate, propionic acidemia therapy mRNA-3927 (partnered with Recordati since early 2026), is in a fully enrolled registrational study with data expected in 2026. With ~$6.9B in cash, 36 development programs, and a targeted return to cash-flow breakeven in 2028, Moderna is a validated-platform leader working through significant near-term financial and execution headwinds.

Company OverviewRead the long-form profile of Moderna

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Main Products

Spikevax

Spikevax

Active

Moderna's original COVID-19 mRNA vaccine (mRNA-1273), the product that validated mRNA vaccines at global scale. Now sold as a seasonal respiratory vaccine and the company's largest historical revenue driver.

Fully FDA-approved (2022) and marketed globally as a seasonal COVID-19 vaccine. The FDA approved the 2026-2027 XFG (JN.1-lineage) formula on August 27, 2026 for high-risk people aged 6 months through 64 and all adults 65 and older; next-generation mNEXSPIKE received the same-season XFG update for high-risk people aged 12 through 64 and all adults 65 and older.

First AuthorizedDec 2020 (EUA); full approval Jan 2022
PlatformmRNA

mRESVIA

Active

mRNA vaccine (mRNA-1345) against respiratory syncytial virus (RSV) - the first mRNA vaccine approved for a disease other than COVID-19, and a key pillar of Moderna's expanding respiratory franchise.

FDA-approved May 2024 for adults 60+, with a US label expansion to at-risk adults 18-59 in June 2025. The European Commission separately extended the EU label to at-risk adults 18-59 in 2026. Small but growing sales as Moderna builds a multi-product respiratory portfolio.

FDA ApprovalMay 2024 (60+); expanded to at-risk 18-59 Jun 2025
IndicationRSV: adults 60+, plus at-risk adults 18-59 (US and EU)

mFlusiva

Active

Moderna's standalone mRNA seasonal influenza vaccine (mRNA-1010), the fourth product in its respiratory franchise alongside Spikevax, mRESVIA, and mCOMBRIAX.

FDA-approved August 5, 2026 for adults 50 and older, with the 65+ indication cleared under accelerated approval contingent on a postmarketing study. In Moderna's Phase 3 trial of over 40,000 adults 50+, mFlusiva was about 27% more effective than a standard flu shot over the 2024-25 season. Moderna expects the vaccine available for adults 50+ this fall.

FDA ApprovalAug 5, 2026 (adults 50+; accelerated approval for 65+)
Trial Efficacy~27% more effective than standard flu shot (Phase 3, 40,000+ adults 50+)

Intismeran autogene (mRNA-4157)

In Development

An individualized neoantigen cancer therapy, co-developed with Merck, that is custom-manufactured for each patient's tumor mutations and given with KEYTRUDA to train the immune system against the cancer. It is Moderna's highest-value pipeline asset.

Investigational. Phase 3 INTerpath-001 (adjuvant melanoma) met both its primary endpoint (recurrence-free survival) and key secondary endpoint (distant metastasis-free survival) in August 2026, the first positive Phase 3 result ever for an individualized mRNA neoantigen cancer therapy; Moderna and Merck plan to file for regulatory approval within months. Phase 3 lung-cancer trials remain enrolling, across nine Phase 2/3 oncology studies.

Melanoma Phase 3 (INTerpath-001)Met primary (RFS) and key secondary (DMFS) endpoints, Aug 2026
Regulatory FilingPlanned within months of Aug 2026 Phase 3 readout

mCOMBRIAX

Active

Moderna's combination COVID-19 and influenza vaccine (mRNA-1083), the world's first authorized flu-plus-COVID combination vaccine, delivered as a single shot.

Approved by the European Commission on April 20, 2026 for adults 50 and older, valid across the EU plus Iceland, Liechtenstein, and Norway. Moderna withdrew its original 2024 US application in May 2025 after the FDA requested additional Phase 3 influenza-efficacy data; with that data now delivered via mFlusiva's August 2026 approval, Moderna plans to resubmit the US application, though it has not announced a timeline.

EU ApprovalApril 20, 2026 (adults 50+)
US StatusApplication withdrawn May 2025; resubmission planned, no date set

mRNA-4194 (INTERCEPT-Lynch)

In Development

An investigational mRNA cancer-prevention vaccine, developed with the University of Oxford, designed to generate immune responses against early cancer-development targets in people with Lynch syndrome - Moderna's first program aimed at preventing cancer before it develops rather than treating existing disease.

Phase 1/2 (INTERCEPT-Lynch), UK MHRA-authorized June 8, 2026; dosing began in the roughly 110-patient study, confirmed in Moderna's Q2 2026 earnings update. A larger Phase 2 expansion across multiple UK centers is expected to begin in 2027.

UK AuthorizationJune 8, 2026
IndicationCancer prevention in Lynch syndrome (~1 in 300 people)

What's Next

File for regulatory approval of intismeran autogene in melanoma

File for regulatory approval of intismeran autogene (mRNA-4157) plus KEYTRUDA in adjuvant melanoma after the pivotal Phase 3 INTerpath-001 trial met both its primary endpoint (recurrence-free survival) and key secondary endpoint (distant metastasis-free survival) on August 19, 2026 - the first positive Phase 3 result ever for an individualized mRNA neoantigen cancer therapy. Moderna and Merck said they plan to submit within months.

Late 2026

Norovirus vaccine Phase 3 extended-cohort readout

Moderna's Phase 3 norovirus vaccine trial (mRNA-1403, NOVA 301, ~38,000 participants) underwent its interim analysis but did not meet the statistical threshold for early success, the company disclosed on July 31, 2026 alongside Q2 earnings. The trial has already relocated across hemispheres more than once chasing enough norovirus cases; Moderna is now enrolling a fourth cohort after slower-than-expected case accrual, pushing a definitive efficacy readout to 2027-2028 at the earliest.

2027-2028

First rare-disease registrational data

Read out registrational data for the propionic acidemia program (mRNA-3927) - Moderna's first rare-disease readout, now partnered with Recordati (deal signed January 2026, closed March 16, 2026: $50M upfront plus up to $110M in milestones and royalties, with Recordati leading global commercialization). The registrational study has reached target enrollment, with data expected in 2026. Moderna is also advancing methylmalonic acidemia therapy mRNA-3705, which was selected for the FDA's START pilot program; the company and FDA have agreed on a pivotal study design, with the registrational study expected to begin in 2026.

2026

Reach cash-flow breakeven

Execute further cost discipline and grow the respiratory, oncology, and rare-disease franchises toward a targeted return to cash-flow breakeven in 2028. Guidance reiterated at Q2 2026 earnings: GAAP operating expenses of approximately $4.9B in 2026, falling to $4.2-4.6B in 2027, on the path to breakeven in 2028.

2028

Begin Phase 2 expansion of mRNA-4194 Lynch syndrome trial

Expand the Phase 1/2 INTERCEPT-Lynch study of mRNA-4194, Moderna's cancer-prevention vaccine for people with Lynch syndrome, into a larger Phase 2 across multiple UK centers - the next step after Phase 1 dosing began in 2026 under the UK MHRA's June 8, 2026 authorization.

2027

Resubmit mCOMBRIAX (mRNA-1083) US application

Resubmit the US Biologics License Application for mCOMBRIAX, the flu-plus-COVID combination vaccine already approved in the EU. Moderna withdrew the original 2024 US application in May 2025 after the FDA requested Phase 3 influenza-efficacy data; that data has now been delivered via mFlusiva's August 5, 2026 approval, clearing the path to resubmit. Moderna has still not announced a specific resubmission timeline, and the FDA's rare refusal-to-file letter on mFlusiva earlier in 2026 (reversed on appeal) could add further delay before the combination shot is refiled.

Timing not yet announced

Track Record

2 of 3 announced dates hit · 1 slipped

Melanoma cancer-vaccine Phase 3 readout

Target 2026–2027 · Resolved Aug 19, 2026

The Phase 3 INTerpath-001 trial of intismeran autogene (mRNA-4157) plus KEYTRUDA met both its primary endpoint (recurrence-free survival) and key secondary endpoint (distant metastasis-free survival) in 1,137 patients with completely resected stage IIB-IV melanoma, the first positive Phase 3 readout ever for an individualized mRNA neoantigen cancer therapy. Moderna shares surged as much as 90%+ intraday and Merck shares rose about 7-11% on the news.

Hit

FDA decision on mRNA flu vaccine (mRNA-1010)

Target Aug 2026 · Resolved Aug 5, 2026

The FDA approved mFlusiva (mRNA-1010) on August 5, 2026 for adults 50 and older, with the 65+ indication under accelerated approval pending a postmarketing study, making it Moderna's fourth approved respiratory product.

Hit

Norovirus vaccine Phase 3 interim analysis

Target 2026 (timing at risk) · Resolved Jul 31, 2026

The interim analysis was conducted but did not meet the statistical threshold for early success; Moderna is enrolling an additional cohort and now expects a definitive efficacy readout in 2027-2028.

Slipped

Operations & Revenue

StatusCommercial, pre-breakeven

Moderna is commercial with multiple approved products but remains loss-making as COVID revenue normalizes: Q2 2026 revenue was $145M (up 2% YoY) against a $782M GAAP net loss, following a $1.3B Q1 2026 loss (worsened by an $878M litigation-settlement charge). The company has raised its projected year-end cash and investments to $4.7-5.2B, has cut ~$2.2B in annual operating expenses with ~$1.5B more targeted by 2027, and aims for cash-flow breakeven in 2028 as its respiratory franchise broadens and oncology and rare-disease programs mature. The FDA approved the mRNA-1010 flu vaccine (mFlusiva) on August 5, 2026, adding a fourth respiratory-franchise product ahead of this fall's flu season, and shares more than doubled after the August 19, 2026 Phase 3 melanoma-vaccine win pushed market cap to roughly $57.9B.

Revenue Streams

COVID-19 vaccines

Spikevax and next-generation mNEXSPIKE remain the dominant revenue source (the bulk of $1.8B FY2025 product sales), though sales are declining and increasingly seasonal and international. The FDA approved the 2026-2027 XFG formulas of both products on August 27, 2026.

RSV & combination vaccines

mRESVIA (RSV) is a small but growing franchise, with its EU label expanded to adults 18+, and mCOMBRIAX (flu+COVID combination) began generating European revenue in 2026.

Collaborations & grants

About $126M of FY2025 'other revenue' came from collaborations and grants, including Merck's ~50% cost-share on the intismeran cancer-vaccine program, licensing, and government funding.

Key Metrics

Employees

~4,800

Est. Annual Revenue

Q2 2026 revenue $145M (up 2% YoY, above guidance); guidance of up to ~10% growth for full-year 2026

FY2025 Revenue

$1.9B (down ~40% YoY)

Cash & Investments

$6.9B (Jun 30, 2026), down from $7.5B in Q1 and before the $950M litigation settlement paid in July 2026; FY2026 year-end cash guided to $4.7-5.2B

Market Cap

~$57.9B (Aug 21, 2026; ~$146/share) - up more than double since Aug 13, after shares surged as much as 177% intraday on the Aug 19 Phase 3 melanoma-vaccine win

Q2 2026 Revenue

$145M (up 2% YoY; above high end of guidance)

Development Programs

36 development programs across 26 development candidates in clinical studies (Jun 30, 2026), incl. 9 Phase 2/3 oncology studies

Approved Products

COVID (Spikevax, mNEXSPIKE), RSV (mRESVIA), flu+COVID combo (mCOMBRIAX, EU), flu (mFlusiva, US, Aug 2026)

FY2025 R&D Spend

$3.13B (down ~31% YoY)

Cost Reductions

~$2.2B annual OpEx cut in 2025 (~$1.5B more targeted by 2027); breakeven targeted 2028

Timeline

2026European approvals for mNEXSPIKE, mRESVIA expansion, and mCOMBRIAX; $950M settlement

The European Commission grants marketing authorization for mNEXSPIKE on February 12, 2026 and for mCOMBRIAX (the flu+COVID combination vaccine) on April 20, 2026, and separately extends the mRESVIA label to at-risk adults ages 18-59 - all valid across the EU plus Iceland, Liechtenstein, and Norway. Moderna also agrees to a ~$950M settlement of the Arbutus/Genevant lipid-nanoparticle patent litigation, with payment made in July 2026.

2026Recordati partnership to commercialize propionic acidemia therapy

On January 29, 2026 Moderna announced a strategic collaboration with Italy's Recordati to develop and globally commercialize mRNA-3927, its investigational therapy for propionic acidemia (PA) and Moderna's most advanced rare-disease program. The deal closed on March 16, 2026: Moderna continues to lead clinical development through approval while Recordati leads worldwide commercialization, paying $50M upfront plus up to $110M in milestone payments and tiered royalties on net sales. The mRNA-3927 registrational study has reached target enrollment, with data expected in 2026.

2026Durable 5-year melanoma cancer-vaccine data at ASCO

At the June 2026 ASCO meeting, Moderna and Merck present five-year Phase 2b data for intismeran autogene (mRNA-4157) plus KEYTRUDA in high-risk resected melanoma, sustaining a ~49% reduction in recurrence-or-death risk versus KEYTRUDA alone.

2026FDA advisory committee backs mRNA flu vaccine 9-0

On June 18, 2026 an FDA advisory committee votes 9-0 that the benefits of Moderna's standalone mRNA seasonal flu vaccine (mRNA-1010, proposed brand mFLUSIVA) outweigh its risks in adults 50+, ahead of an expected ~August 5, 2026 FDA decision. The vote drives a sharp stock rally.

2026First patient dosed in mRNA-4200 solid-tumor trial

On July 16, 2026 Moderna dosed the first U.S. participant in a Phase 1 trial of mRNA-4200, an off-the-shelf, tumor-targeted cancer antigen therapy given with checkpoint-inhibitor treatment in adults with advanced or metastatic solid tumors. The candidate - Moderna's third off-the-shelf cancer antigen therapy, developed with Immatics - encodes seven antigens commonly shared across patients and tumor types to induce and expand T-cell responses. The open-label, multicenter, dose-escalation study is evaluating safety and tolerability, extending Moderna's oncology pipeline beyond the individualized intismeran autogene program.

2026Q2 2026 results: revenue beats guidance, loss narrows

Moderna reported second-quarter 2026 revenue of $145M, up 2% year over year and above the high end of prior guidance, with a GAAP net loss of $782M ($1.97/share) as cost of sales, R&D, and SG&A all declined versus a year earlier. The company reiterated guidance for up to 10% revenue growth in 2026 and raised its projected year-end cash and investments to $4.7-5.2B.

2026Norovirus vaccine Phase 3 interim analysis misses efficacy bar

Moderna disclosed on July 31, 2026 that the Phase 3 interim analysis of its norovirus vaccine candidate mRNA-1403 (NOVA 301, ~38,000 participants) did not meet the statistical threshold for early success. The company is enrolling an additional cohort after slower-than-expected case accrual, pushing a definitive readout to 2027-2028, while maintaining its full-year revenue growth guidance.

2026mFlusiva (mRNA-1010) FDA-approved

The FDA approved mFlusiva on August 5, 2026 for seasonal influenza in adults 50 and older, with the 65+ indication under accelerated approval pending a postmarketing study. It becomes Moderna's fourth approved respiratory product alongside Spikevax, mRESVIA, and mCOMBRIAX.

2026First cancer-prevention program: dosing begins in mRNA-4194 Lynch syndrome study

The UK MHRA authorizes INTERCEPT-Lynch on June 8, 2026, a Phase 1/2 study (with the University of Oxford) of mRNA-4194, Moderna's first mRNA vaccine designed to prevent cancer before it develops rather than treat existing disease, in the roughly 1-in-300 people with Lynch syndrome. Moderna's Q2 2026 earnings update confirms dosing has begun, alongside the separate Phase 1 mRNA-4200 solid-tumor study, as its two newest cancer antigen therapy programs.

2026Phase 3 melanoma vaccine trial meets primary and secondary endpoints

The Phase 3 INTerpath-001 trial of intismeran autogene (mRNA-4157) plus KEYTRUDA meets both its primary endpoint of recurrence-free survival and its key secondary endpoint of distant metastasis-free survival in 1,137 patients with completely resected stage IIB-IV melanoma, announced August 19, 2026 - the first positive Phase 3 result ever for an individualized mRNA neoantigen cancer therapy. Moderna and Merck say they plan to file for regulatory approval within months.

2026Phase 1 trial opens for combined RSV/hMPV vaccine

Moderna starts a Phase 1 randomized, dose-escalation trial of mRNA-1365 (Profile 2), a multicomponent vaccine targeting both RSV and human metapneumovirus in a single shot for adults 60 and older, first submitted to the clinical trial registry on August 10, 2026. The study compares the combination candidate's safety and immune response against two versions of Moderna's already-approved single-pathogen RSV vaccine mRESVIA, broadening the respiratory-vaccine pipeline beyond COVID-19 and standalone RSV shots.

2026FDA approves 2026-2027 XFG Spikevax and mNEXSPIKE formulas

On August 27, 2026 the FDA approved the 2026-2027 formulas of Spikevax and mNEXSPIKE, both targeting the JN.1-lineage XFG subvariant of SARS-CoV-2. Spikevax is cleared for high-risk people aged 6 months through 64 and all adults 65 and older; mNEXSPIKE is cleared for high-risk people aged 12 through 64 and all adults 65 and older. Moderna said the updated shots should be available in the coming days.

2025mNEXSPIKE approved; deep cost cuts and layoffs

Next-generation, lower-dose COVID vaccine mNEXSPIKE (mRNA-1283) is approved. Facing a post-COVID revenue decline, Moderna cuts ~$2.2B of annual operating expenses and lays off ~10% of its workforce (500+ roles), targeting fewer than 5,000 employees.

2025Phase 3 CMV vaccine misses primary endpoint; congenital program discontinued

On October 22, 2025 Moderna announces that the pivotal Phase 3 CMVictory trial of its cytomegalovirus vaccine mRNA-1647 - the largest CMV vaccine study ever run, enrolling ~7,500 women across 13 countries - missed its primary efficacy endpoint of preventing CMV infection in seronegative women of childbearing age (efficacy of only 6-23% depending on case definition). Moderna discontinues the congenital CMV program but continues a smaller Phase 2 study of mRNA-1647 in transplant patients.

2024mRESVIA (RSV vaccine) approved - second product

The FDA approves mRESVIA (mRNA-1345) for RSV in older adults in May 2024, making it Moderna's second commercial product and the first mRNA vaccine approved for a disease other than COVID-19.

2022Spikevax full FDA approval; revenue peaks

Spikevax receives full FDA approval in January 2022. COVID vaccine sales drive Moderna's revenue to a peak of more than $18B for the year.

2020COVID-19 vaccine receives FDA Emergency Use Authorization

mRNA-1273 (later Spikevax), developed with support from Operation Warp Speed (~$955M), receives FDA EUA on December 18, 2020 - Moderna's first product and the validation of mRNA vaccines at global scale.

2018Largest biotech IPO ever

Lists on NASDAQ under ticker MRNA in December 2018, raising ~$621M (27M shares at $23) - the largest biotech IPO to that point.

2015$450M Series E - then the largest private biotech round

Raises $450M in one of the largest private financings in biotech history, and forms a foundational oncology collaboration with Merck that later underpins the mRNA-4157/V940 cancer vaccine.

2013AstraZeneca partnership and DARPA grant

Signs a cardiometabolic and cancer partnership with AstraZeneca ($240M upfront) and receives a $25M DARPA grant, validating the platform with major backers before any product exists.

2011Stéphane Bancel becomes CEO

Bancel, previously CEO of diagnostics firm bioMérieux, takes the helm and begins building Moderna's mRNA platform. He remains CEO through 2026.

2010Founded as ModeRNA Therapeutics

Incubated by Flagship Pioneering in Cambridge, Massachusetts, around the idea of using messenger RNA to instruct cells to produce their own therapeutic proteins. Founding figures include Derrick Rossi, Robert Langer, Kenneth Chien, Timothy Springer, and Noubar Afeyan.

Funding

Cumulative disclosed raise · dated rounds

$2B$4B$6B20132016201920222025$5.7B raised
RoundDateAmountInvestorsSource
Series E2015$450MFlagship Pioneering, crossover institutional investors
Late-stage private rounds2016–2017~$1B+Flagship Pioneering, Gates Foundation, sovereign and institutional investors
IPO (NASDAQ: MRNA)2018$621MPublic markets
Non-dilutive (government & foundations)2013–2021~$1B+DARPA, BARDA/Operation Warp Speed (~$955M), CEPI, Gates Foundation
Convertible senior notes (due 2032)Aug 2026$2.6B (0.00% coupon, upsized from a planned $2.0B)Private placement to qualified institutional buyers; initial conversion price ~$210.58/share (47.5% premium to the Aug 27, 2026 close), paired with capped call transactions capped near $392.62/share

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Oklo

Biotech

Oklo is developing fast-fission power plants under its Aurora product line while building a vertically integrated nuclear business around power sales, fuel recycling, and radioisotopes. Aurora units are designed to produce 15-75 MWe and run on fresh, recycled, or down-blended fuel, targeting customers such as data centers, industrial sites, military facilities, utilities, and remote communities. Its first plant, Aurora-INL at Idaho National Laboratory, is advancing under DOE's Reactor Pilot Program - the DOE approved its Preliminary Documented Safety Analysis on June 11, 2026, leaving the final Documented Safety Analysis as the last safety-basis step before authorization. Oklo is deepening vertical integration through the June 2026 acquisitions of Oak Ridge precision manufacturer ARMEC and sodium-systems engineering firm Creative Engineers, plus its May 2026 selection for DOE's Surplus Plutonium Utilization Program, while Atomic Alchemy builds U.S. isotope supply around the Groves test reactor in Lockhart, Texas, which reached first criticality on August 5, 2026.

TAE Technologies logo

TAE Technologies

Biotech

TAE Technologies is a private fusion company developing hydrogen-boron fusion with a beam-driven field-reversed-configuration architecture. Its 2025 'Norm' breakthrough reduced reactor complexity enough to skip the planned Copernicus step and move directly toward Da Vinci, its first prototype power plant. In 2026 TAE completed its multi-state site evaluation tour for the first 50 MWe plant (Alabama, Ohio, Texas), formally established the TAE Beam UK joint venture with UKAEA at Culham to commercialize neutral-beam accelerator technology, and is now targeting a Q4 2026 close of its $6B all-stock merger with Trump Media & Technology Group, which in June 2026 confirmed it will no longer spin off Truth Social and other media assets ahead of the deal. TAE Power Solutions and TAE Life Sciences commercialize adjacent power-delivery and oncology technologies derived from its fusion R&D.