Moderna
Moderna, Inc. is an American biotechnology company specializing in the research, development, and commercialization of messenger RNA (mRNA)-based therapeutics and vaccines for serious diseases, including infectious diseases, immuno-oncology, rare diseases, and cardiovascular conditions.[1] Founded in 2010 by Noubar Afeyan, Robert Langer, and Derrick Rossi through Flagship Pioneering, the company is headquartered in Cambridge, Massachusetts, and has pioneered mRNA technology to instruct human cells to produce proteins that combat illness.[2][3] Under CEO Stéphane Bancel, who joined in 2011, Moderna advanced its platform with strategic partnerships, culminating in the rapid creation of Spikevax (mRNA-1273), its COVID-19 vaccine developed in collaboration with the National Institutes of Health (NIH).[4] The vaccine received emergency use authorization from the U.S. Food and Drug Administration (FDA) on December 18, 2020, after phase 3 clinical trials showed 94.1% efficacy in preventing symptomatic COVID-19 in adults, with no severe cases in the vaccinated group.[5][6] This breakthrough propelled Moderna to commercial success, with Spikevax generating peak sales of $18.4 billion in 2022, though revenues later declined amid reduced demand and competition.[7] The company's mRNA approach enabled unprecedented development speed, supported by government funding and derisking mechanisms, but has sparked disputes, including a legal battle with the NIH over patent inventorship for stabilizing lipid nanoparticles critical to vaccine delivery.[8][9] Beyond COVID-19, Moderna expanded its portfolio with FDA approval of mRESVIA, an RSV vaccine for older adults, in 2024, and maintains a broad pipeline targeting influenza, cytomegalovirus, and personalized cancer therapies, reflecting ongoing innovation despite post-pandemic financial pressures and safety monitoring for rare adverse events like myocarditis confirmed in real-world data.[10][11][12]Company Overview
Founding and Early Milestones
Moderna was founded in 2010 by Noubar Afeyan, founder and CEO of Flagship Pioneering, in collaboration with Robert Langer, a professor of chemical engineering at MIT, and Derrick Rossi, a stem cell biologist, with the aim of developing messenger RNA (mRNA) therapeutics as a novel drug modality.[13][14] The company originated from exploratory work within Flagship's VentureLabs, initially codenamed LS18, and was renamed Moderna Therapeutics to reflect its focus on modified RNA technologies; provisional patents for mRNA applications were filed as early as July and October 2010.[13] Stéphane Bancel joined as CEO in October 2011, bringing prior experience from roles at Eli Lilly and BioMérieux to lead operations amid the nascent field of mRNA research.[15] Early financing included a $40 million round announced in November 2012 to advance mRNA drug development, supported by investors including Flagship Pioneering, which provided foundational backing as the incubator.[14] Key early milestones included a multiyear partnership with AstraZeneca in 2013 to develop mRNA-based therapeutics for cardiovascular and metabolic diseases, alongside a $24.6 million grant from the Defense Advanced Research Projects Agency (DARPA) awarded on October 2, 2013, to support preclinical development of mRNA-encoded antibody candidates under the ADEPT program.[16] In 2014, Moderna opened expanded headquarters and laboratories in Cambridge, Massachusetts, and formed a collaboration with Alexion Pharmaceuticals for rare disease applications.[15] A significant technical achievement occurred in 2015 with the administration of the first human dose of an investigational mRNA vaccine (mRNA-1440) targeting the H10N8 influenza strain, marking the transition from preclinical to clinical testing.[15]Leadership and Organizational Structure
Stéphane Bancel has served as Chief Executive Officer of Moderna since October 2011, overseeing the company's strategic direction, including its expansion into mRNA-based therapeutics and vaccines.[4] Prior to Moderna, Bancel held executive roles at bioMérieux and Eli Lilly, bringing expertise in diagnostics and pharmaceuticals.[17] The executive leadership team comprises key functional heads reporting to Bancel, including Stephen Hoge, M.D., as President, responsible for operational oversight; Jamey Mock as Chief Financial Officer, managing financial strategy and accounting; Jacqueline Miller, M.D., as Chief Medical Officer, leading clinical development; and Jerh Collins, Ph.D., as Chief Technical Operations and Quality Officer, handling manufacturing and supply chain.[4] Other senior roles include Tracey Franklin as Chief People and Digital Technology Officer, a position reflecting Moderna's 2025 merger of human resources and information technology functions to integrate AI-driven efficiencies across talent management and digital infrastructure.[4][18] Shannon Thyme Klinger serves as Chief Legal Officer and Corporate Secretary, addressing regulatory and compliance matters.[4] Moderna maintains a functional organizational structure, with specialized departments in research and development, clinical operations, quality assurance, and regulatory compliance, enabling focused expertise in mRNA platform advancement while supporting scalability in production and commercialization.[19] The Board of Directors, chaired by co-founder Noubar Afeyan since the company's inception, provides governance and strategic guidance, comprising ten members including Bancel, independent directors such as Sandra Horning, M.D., former Chief Medical Officer at Roche, and Elizabeth Nabel, M.D., former President of Brigham Health, alongside experts in finance and biotech like David M. Rubenstein, Co-Founder of The Carlyle Group.[4] The board's composition emphasizes scientific, operational, and financial acumen to align with Moderna's mission in therapeutic innovation.[4]Core Mission and Strategic Focus
Moderna's stated mission is to deliver on the promise of mRNA science to create a new generation of transformative medicines for patients, with a focus on using its mRNA platform and supporting infrastructure to address infectious diseases and serious conditions.[1] This entails prompting the body's cells to produce proteins that combat disease, either by eliciting immune responses for vaccines or directly treating underlying pathologies in therapeutics.[20] The approach prioritizes diseases lacking effective treatments, such as certain cancers, rare genetic disorders, and latent viral infections, under the principle that mRNA's versatility allows broad applicability if successful in one area.[20] Strategically, Moderna emphasizes speed in mRNA design and iteration, enabling the testing of multiple candidates within days via computational tools and scalable manufacturing, which shortens traditional development timelines from years to months.[1] As of January 2025, the company's priorities include driving revenue growth from existing products, securing up to 10 regulatory approvals over the ensuing three years across vaccines and therapeutics, and enforcing cost discipline to achieve cash flow break-even by 2028, amid a 41% revenue decline in the first half of 2025 largely attributable to reduced COVID-19 vaccine demand.[21][22] This has prompted a $1.5 billion cost-cutting initiative, including R&D optimization, while maintaining investments in high-potential areas like oncology and respiratory virus combinations.[22][23] The firm's pipeline reflects this dual emphasis on mission-driven innovation and pragmatic commercialization, with ongoing programs in mRNA-based individualized neoantigen therapies for cancer, prophylactic vaccines for cytomegalovirus and respiratory syncytial virus, and exploratory efforts in autoimmune and cardiovascular diseases, all aimed at mitigating reliance on pandemic-era successes.[20] Accessibility features, such as avoiding animal-derived components and preservatives in formulations, underscore a commitment to scalable, equitable deployment of mRNA medicines globally.[1]Technological Platform
Development of mRNA Technology
Moderna's development of mRNA technology originated from foundational research in chemical modifications to messenger RNA, aimed at reducing innate immune activation that previously limited its therapeutic potential. In 2010, the company was established by Derrick Rossi, a stem cell biologist, alongside Noubar Afeyan and Robert Langer, to commercialize Rossi's work on modified mRNA conducted at Harvard's Stem Cell Institute. Rossi's team demonstrated that incorporating nucleoside analogs, such as pseudouridine, into synthetic mRNA enabled efficient cellular reprogramming without triggering severe inflammatory responses, as shown in experiments converting adult fibroblasts into induced pluripotent stem cells.[24][25] This modification built on prior discoveries by Katalin Karikó and Drew Weissman, who in 2005 reported that pseudouridine substitution evaded Toll-like receptor detection, but Rossi's application to transient protein expression marked a shift toward scalable therapeutics.[26] The platform's core innovation lay in treating mRNA as a programmable digital code, where sequence design and nucleoside chemistry were optimized iteratively to enhance stability, translation efficiency, and payload specificity. Early efforts at Moderna involved high-throughput screening of modified mRNA variants to identify those yielding higher protein expression levels in vivo, with pseudouridine and N1-methylpseudouridine proving particularly effective in suppressing interferon responses while boosting half-life.[27] By 2012, the company had advanced to preclinical models, demonstrating dose-dependent protein production for applications beyond stem cells, such as cytokine replacement and vaccine antigens. This modality-centric approach emphasized repeatability across targets, contrasting with traditional biologics by enabling rapid iteration via computational sequence prediction rather than cell-line engineering.[28] Subsequent refinements addressed remaining challenges like mRNA degradation and off-target effects, incorporating 5' cap analogs and poly-A tail optimizations to mimic endogenous transcripts more closely. In 2013, Moderna secured a $25 million DARPA contract to develop mRNA-based therapeutics for infectious diseases, validating the platform's viability and funding further lipid formulation integration for delivery—though core mRNA engineering remained the foundational step. These developments positioned mRNA as a versatile template for encoding any protein of interest, with empirical data from rodent and non-human primate studies confirming expression levels up to 1,000-fold higher than unmodified RNA. Peer-reviewed validations underscored the causal link between nucleoside modifications and reduced immunogenicity, enabling progression to human trials by the mid-2010s.[29][30]Key Innovations in Delivery and Stability
Moderna's advancements in mRNA delivery center on proprietary lipid nanoparticle (LNP) formulations, which encapsulate mRNA to shield it from extracellular degradation and enable efficient intracellular delivery. These LNPs typically comprise an ionizable cationic lipid (such as SM-102 in their COVID-19 vaccine mRNA-1273), a helper phospholipid, cholesterol for membrane fusion, and a polyethylene glycol (PEG)-lipid for steric stabilization. The ionizable lipid remains neutral at physiological pH to minimize toxicity but protonates in the acidic endosome, promoting membrane disruption and mRNA release into the cytoplasm.[31] This LNP design facilitates endocytic uptake by antigen-presenting cells, with Moderna's proprietary variants demonstrating enhanced local protein expression and reduced reactogenicity compared to non-optimized formulations, as evidenced in preclinical and clinical data from their vaccine programs.[32] Further innovations include tailored LNPs for alternative administration routes, such as pulmonary inhalation via nebulization or intratumoral injection, expanding beyond intramuscular delivery to target mucosal or tumor microenvironments.[33] In parallel, Moderna has pioneered mRNA stability enhancements through chemical and structural modifications that mitigate rapid enzymatic degradation and innate immune activation. A cornerstone is the substitution of all uridines with N1-methylpseudouridine (m1Ψ), which dampens recognition by Toll-like receptors (TLRs) and RIG-I-like receptors, thereby extending mRNA half-life in cells while amplifying translational output—key to achieving robust antigen expression in vaccines like mRNA-1273.[34] [35] Complementary optimizations include codon usage adjustment to favor high-expression sequences, proprietary 5' untranslated regions (UTRs) that promote efficient ribosome scanning and initiation, and 3' UTRs derived from stability-conferring human genes to prolong cytoplasmic persistence. These elements, combined with a Cap 1 structure at the 5' end and an extended poly-A tail, collectively yield mRNAs with superior durability and immunogenicity profiles over unmodified counterparts.[36] [37]Historical Product Development
Pre-Pandemic Research and Trials
Moderna's pre-pandemic efforts focused on pioneering mRNA-based vaccines and therapeutics, building on foundational work in lipid nanoparticle delivery systems to encapsulate and stabilize synthetic mRNA for cellular uptake. Established in 2010, the company prioritized infectious diseases, oncology, and rare genetic disorders, conducting early-phase clinical trials to assess safety, tolerability, and immunogenicity without achieving regulatory approvals prior to 2020. Research emphasized unmodified and modified mRNA constructs to mitigate innate immune activation, a persistent hurdle in earlier mRNA studies.[38][39] The company's inaugural human trials began in 2015 with Phase 1 studies for an influenza vaccine candidate, mRNA-1440, which encoded hemagglutinin proteins from H10N8 and H7N9 strains and elicited dose-dependent antibody responses in healthy adults, though with notable injection-site reactions and systemic symptoms. In 2016, Moderna expanded to Phase 1 evaluations of mRNA vaccines against Zika virus and Chikungunya virus, demonstrating neutralizing antibody production but underscoring needs for optimized dosing to balance efficacy and reactogenicity. By 2017, a Phase 1 trial for a cytomegalovirus (CMV) vaccine, mRNA-1647, targeted glycoprotein B and matrix proteins to induce both humoral and cellular immunity, advancing understanding of multivalent mRNA immunogenicity in preventing congenital infections. Additional Phase 1 efforts included respiratory syncytial virus (RSV) and rabies vaccines, with preclinical data supporting progression but clinical results revealing variable T-cell responses.[40][39] Beyond infectious diseases, Moderna pursued mRNA therapeutics for cancer and rare diseases through strategic partnerships that facilitated trial initiation. In 2016, a collaboration with Merck launched Phase 1 trials of personalized neoantigen-targeted mRNA-4157 for melanoma and other solid tumors, combining mRNA with immune checkpoint inhibitors to enhance tumor-specific T-cell responses. Agreements with Alexion (2015) for propionic acidemia and methylmalonic acidemia, and Vertex (2015) for cystic fibrosis, yielded Phase 1/2 studies of mRNA-encoded enzymes, though efficacy remained limited by transient protein expression. Funding from DARPA ($25 million in 2013 for trauma applications) and the Gates Foundation (2016 investment) supported platform maturation, yet trials consistently encountered delivery inefficiencies and off-target immune effects, stalling advancement to later phases.[38][8]COVID-19 Vaccine Acceleration (mRNA-1273)
In response to the January 10, 2020, public release of the SARS-CoV-2 genetic sequence by Chinese researchers, Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) collaboratively designed the mRNA-1273 vaccine candidate within two days, encoding the full-length SARS-CoV-2 spike protein stabilized in its prefusion conformation.[41] The first vial of mRNA-1273 was produced on January 13, 2020, followed by shipment to the NIH for animal studies on January 24, with immunogenicity confirmed in mice by early February.[41] This rapid initiation leveraged Moderna's pre-existing mRNA platform, developed over a decade through prior investments in lipid nanoparticle delivery and mRNA stabilization technologies, which had been tested in non-COVID applications like influenza and Zika vaccines.[42] An investigational new drug application was submitted to the FDA in late February 2020, enabling the Phase 1 clinical trial to commence on March 16, 2020, in healthy adults aged 18-55, evaluating safety, reactogenicity, and immunogenicity across escalating doses of 25-100 μg administered in two intramuscular injections 28 days apart.[43][44] The accelerated timeline incorporated overlapping clinical phases and at-risk manufacturing, supported by substantial U.S. government funding through the Biomedical Advanced Research and Development Authority (BARDA). Initial BARDA awards totaling approximately $955 million facilitated preclinical scaling and Phase 1/2 trials, while an August 11, 2020, agreement added up to $1.525 billion to produce and deliver 100 million doses contingent on Phase 3 success, bringing total Warp Speed investment to about $2.5 billion.[45][46] Phase 2 expansion in May 2020 assessed immunogenicity in broader age groups, including older adults and those with comorbidities, showing robust neutralizing antibody responses comparable to Phase 1.[43] The pivotal Phase 3 COVE trial, a randomized, placebo-controlled study enrolling 30,420 participants starting July 27, 2020, evaluated efficacy against virologically confirmed COVID-19 occurring at least 14 days after the second dose, with primary endpoints focusing on symptomatic disease prevention.[47] This compression of traditional sequential development—typically spanning 10-15 years—relied on prior mRNA immunogenicity data, real-time data sharing with regulators, and parallel process validation for Good Manufacturing Practice production.[48] Interim Phase 3 results, analyzed by an independent data and safety monitoring board in November 2020, demonstrated 94.1% efficacy (95% CI, 89.3-96.8) in preventing COVID-19 illness among 185 confirmed cases (11 in vaccine group vs. 185 in placebo), including 100% efficacy against severe disease, based on 30 cases (zero vaccine-related).[6] Safety data indicated mostly transient reactogenicity, with grade 3 local reactions in 2.7% after dose 1 and 16.5% after dose 2, and systemic events like fatigue (9.7%) and headache (4.5%) more common post-dose 2, but no vaccine-associated enhanced disease or excess serious adverse events beyond placebo rates.[6] These findings prompted the FDA to issue Emergency Use Authorization for mRNA-1273 on December 18, 2020, for individuals 18 years and older, following review of manufacturing data and a 2:1 benefit-risk assessment amid surging pandemic cases.[49] Full dataset confirmation in December 2020 upheld the efficacy and safety profile, with longer-term follow-up through May 2021 showing sustained protection beyond five months.[50] The program's success highlighted causal factors like massive parallel funding and regulatory emergency provisions, though it involved financial risks from pre-emptive scale-up of unproven candidates.[45]Post-2020 Expansions and Approvals
Following the Emergency Use Authorization of its COVID-19 vaccine (mRNA-1273, branded Spikevax) on December 18, 2020, Moderna pursued label expansions and full approvals. On October 21, 2021, the U.S. FDA authorized a booster dose of Spikevax for adults aged 65 and older, as well as certain high-risk individuals aged 18-64, based on clinical data demonstrating sustained immunogenicity.[51] This was followed by full Biologics License Application approval on January 31, 2022, for individuals 18 years and older, supported by phase 3 trial results showing 93% efficacy against symptomatic COVID-19 and a safety profile consistent with EUA data from over 30,000 participants.[52] Subsequent expansions included EUAs for pediatric use in June 2022 (ages 6 months to 17 years) and bivalent boosters targeting Omicron variants in August 2022, reflecting iterative adaptations to emerging SARS-CoV-2 strains.[53] Moderna continued annual updates to Spikevax formulations, with the FDA approving the 2024-2025 version on August 22, 2024, for ages 12 and older, incorporating antigens matched to circulating variants like KP.2.[54] In July 2025, full approval was extended to high-risk individuals aged 6 months through 64 years.[55] A next-generation COVID-19 vaccine, mNEXSPIKE (mRNA-1283), received FDA approval in May 2025 for adults, demonstrating superior neutralizing antibody responses compared to Spikevax in phase 3 trials, marking Moderna's first approved mRNA-based update beyond the original platform.[56] Further refinements included approvals for 2025-2026 formulas targeting the LP.8.1 variant on August 27, 2025, and September 8, 2025, respectively, for Spikevax and mNEXSPIKE in eligible populations.[53] [57] Beyond COVID-19, Moderna's first non-COVID approval came with mRESVIA (mRNA-1345), an RSV vaccine granted full FDA approval on May 31, 2024, for preventing lower respiratory tract disease in adults aged 60 and older, based on the ConquerRSV phase 3 trial showing 83.7% efficacy against RSV-associated illness over 18 months.[58] This represented a significant pipeline expansion into respiratory viruses, leveraging mRNA technology for rapid antigen design. On June 12, 2025, the approval was broadened to adults aged 18-59 at increased risk for severe RSV, supported by immunogenicity bridging studies and safety data from over 37,000 participants across trials.[59] These approvals diversified Moderna's portfolio from pandemic-focused products to routine preventive vaccines, though ongoing programs in influenza and combination vaccines remained in clinical stages without post-2020 approvals as of October 2025.[12]Current Products and Pipeline
Approved Vaccines and Therapeutics
Moderna has two commercially available mRNA vaccines approved by regulatory authorities: Spikevax for COVID-19 prevention and mRESVIA for respiratory syncytial virus (RSV) lower respiratory tract disease prevention.[12] A next-generation COVID-19 vaccine, mNEXSPIKE, also received U.S. Food and Drug Administration (FDA) approval in 2025.[60] As of October 2025, Moderna has no approved therapeutics, with its pipeline focused on investigational treatments for oncology, rare diseases, and infectious diseases remaining in clinical stages.[12] Spikevax (mRNA-1273), Moderna's flagship COVID-19 vaccine, encodes a stabilized prefusion spike protein of SARS-CoV-2 to elicit immune responses. The FDA granted emergency use authorization (EUA) on December 18, 2020, for individuals 18 years and older, followed by full approval on January 31, 2022, for the same population to prevent COVID-19.[61] The European Medicines Agency (EMA) issued conditional marketing authorization on January 6, 2021, converted to standard authorization later.[62] Indications expanded to include children aged 6 months through 11 years at high risk for severe disease, with full FDA approval for this group on July 10, 2025.[51] Annual updates target circulating variants; the 2025-2026 formulation, monovalent against the LP.8.1 lineage, was FDA-approved on August 27, 2025, revoking prior EUAs for superseded versions.[61][51] mRESVIA (mRNA-1345) targets the RSV F glycoprotein in prefusion conformation to prevent RSV-associated lower respiratory tract disease. The FDA approved it on May 31, 2024, for adults aged 60 years and older, based on phase 3 trial data showing 83.7% efficacy against RSV-confirmed lower respiratory tract disease over 3.7 months median follow-up.[59][63] EMA authorization followed on August 15, 2024.[64] In June 2025, the FDA expanded approval to adults aged 18 to 59 at increased risk for RSV disease, addressing gaps in younger high-risk populations such as those with chronic conditions.[65][66] mNEXSPIKE, a second-generation COVID-19 vaccine, was FDA-approved on September 25, 2025, for active immunization against COVID-19 in individuals aged 12 years and older, featuring an optimized spike protein design for potentially broader and more durable immunity compared to Spikevax.[60] It targets SARS-CoV-2 variants including LP.8.1, aligning with seasonal update strategies.[57]| Product | Indication | Key Approvals | Target Population |
|---|---|---|---|
| Spikevax (mRNA-1273) | Prevention of COVID-19 | FDA full approval Jan 31, 2022 (adults 18+); updates through 2025-2026 | 6 months+ (high-risk children); 12+ (broader) |
| mRESVIA (mRNA-1345) | Prevention of RSV lower respiratory tract disease | FDA approval May 31, 2024 (60+); expanded Jun 2025 (18-59 at risk) | Adults 18+ at risk; primarily 60+ |
| mNEXSPIKE | Prevention of COVID-19 | FDA approval Sep 25, 2025 | 12+ years |
Ongoing Clinical Programs
Moderna's ongoing clinical programs primarily utilize its mRNA platform to develop vaccines and therapeutics across infectious diseases, oncology, and rare genetic disorders, with a strategic emphasis on respiratory viruses, latent infections, cancer immunotherapies, and inborn errors of metabolism. Following the October 2025 discontinuation of its cytomegalovirus (CMV) vaccine candidate mRNA-1647 after it demonstrated insufficient protective efficacy in a Phase 3 trial against congenital CMV infection in women of childbearing age, the company has refocused resources on higher-priority assets.[67][12] This shift aligns with broader portfolio prioritization announced in early 2025, aiming for advancements in areas with demonstrated proof-of-concept data.[21] In respiratory vaccines, several candidates remain in late-stage development. mRNA-1010, a seasonal influenza vaccine, is in Phase 3 trials evaluating immunogenicity and efficacy against contemporary strains. mRNA-1083, a combination vaccine targeting both influenza and SARS-CoV-2, is also advancing in Phase 3, with data supporting potential non-inferiority to monovalent counterparts in adults aged 50 and older. Earlier-stage efforts include mRNA-1365 for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in Phase 1, building on Moderna's approved RSV vaccine mRNA-1345, which is under further pediatric evaluation in Phase 2.[12][68] Oncology programs represent a core focus, leveraging individualized neoantigen-specific immunotherapies. mRNA-4157 (intisemeran autogene), developed in collaboration with Merck, is in multiple Phase 3 trials as an adjuvant therapy, including for resected melanoma (KEYNOTE-942 follow-on), non-small cell lung cancer (NSCLC) post-resection, and NSCLC without pathologic complete response after neoadjuvant therapy; interim data from melanoma trials showed a 49% reduction in recurrence or death risk when combined with pembrolizumab. Phase 2 evaluations of mRNA-4157 extend to renal cell carcinoma, muscle-invasive urothelial carcinoma, non-muscle invasive bladder cancer, and metastatic melanoma, while Phase 1 studies explore broader solid tumors. Complementing this, mRNA-4359, a checkpoint immunotherapy targeting multiple tumor-associated antigens, is in Phase 2 for advanced solid tumors, with early signals of immune activation reported at ESMO 2025. mRNA-4106 remains in Phase 1 for solid tumors.[12][69][70] For latent and other viral vaccines, active trials include mRNA-1608 (HSV-2 therapeutic vaccine) in Phase 2 for healthy adults aged 18-55, assessing safety and immunogenicity; mRNA-1189 and mRNA-1195 (Epstein-Barr virus vaccines) in Phase 2 for preventing infectious mononucleosis and long-term sequelae, respectively; and mRNA-1468 (varicella-zoster virus) in Phase 2. Norovirus programs feature mRNA-1403 in Phase 3 and mRNA-1405 in Phase 2, while Lyme disease candidates mRNA-1975 and mRNA-1982 are both in Phase 2. Earlier phases cover HIV (mRNA-1644, Phase 1), Nipah (mRNA-1215, Phase 1), and mpox (mRNA-1769, Phase 1).[12][71] Rare disease therapeutics target metabolic disorders via mRNA-encoded enzymes. mRNA-3927 for propionic acidemia is in Phase 2, evaluating liver expression of propionyl-CoA carboxylase in pediatric and adult patients. Similarly, mRNA-3705 for methylmalonic acidemia is in Phase 2, focusing on methylmalonyl-CoA mutase replacement. Phase 1 programs include mRNA-3745 for glycogen storage disease type 1a and a collaboration with Vertex on mRNA-3692/VX-522 for cystic fibrosis, assessing alternative CFTR mRNA delivery. These efforts aim to provide transient, repeat-dosable protein replacement without genomic integration risks associated with gene therapies.[12][21]Recent Developments and Setbacks
In 2025, Moderna reported positive topline results from a Phase 3 trial of its seasonal influenza vaccine candidate mRNA-1010, demonstrating a relative vaccine efficacy of 26.6% (95% CI: 16.7%-35.4%) against influenza-like illness compared to a licensed standard-dose quadrivalent influenza vaccine in adults aged 50 and older.[72] The company plans to submit regulatory filings for approval based on these data, which also included immunogenicity endpoints meeting superiority criteria.[73] Additionally, Moderna presented data on mRNA-1010 and an H5 pandemic influenza candidate at IDWeek 2025, highlighting ongoing advancements in respiratory virus vaccines.[74] The company's RSV vaccine mRESVIA (mRNA-1345) received FDA approval on May 31, 2024, for adults aged 60 and older to prevent lower respiratory tract disease caused by RSV, with expanded approval on June 13, 2025, for high-risk adults aged 18 to 59.[65] Preliminary Phase 4 results in September 2025 showed the updated Spikevax COVID-19 vaccine formula eliciting an eight-fold increase in neutralizing antibodies against the LP.8.1 variant.[75] However, Moderna discontinued development of its cytomegalovirus (CMV) vaccine mRNA-1647 on October 23, 2025, after a Phase 3 trial failed to meet its primary efficacy endpoint of preventing primary CMV infection in women aged 16 to 40, with the vaccine showing limited protective effect against congenital CMV transmission.[76] Previously viewed as a potential multibillion-dollar product, the halt aligns with broader cost-cutting measures, including a $4 billion R&D budget reduction announced in September 2024.[67] In January 2025, Moderna slashed its sales guidance for 2024 and 2025, citing lower-than-expected COVID-19 vaccine uptake, leading to a 17% stock drop.[77] Despite these challenges, the company continues to prioritize its oncology and rare disease pipeline, with ongoing Phase 3 programs in cancer vaccines.[69]Financial Trajectory
Revenue Generation and Sources
Moderna generates revenue primarily through commercial sales of its approved mRNA vaccines, with product sales comprising approximately 97% of total revenue in recent years. The company's core product, Spikevax (also known as mRNA-1273), a COVID-19 vaccine, has been the dominant source, contributing $3.1 billion in net sales for fiscal year 2024, down from higher pandemic-era volumes due to reduced global demand for boosters.[78][79] In the second quarter of 2025, Spikevax sales totaled $114 million, including $88 million from the U.S. market.[80] A secondary product line emerged in 2024 with the U.S. FDA approval of mRESVIA (mRNA-1345), an RSV vaccine for adults aged 60 and older, which generated $15 million in sales during the fourth quarter of 2024 as initial commercialization began.[78] This launch marked Moderna's transition to a multi-product company, though RSV sales remain nascent and are projected to grow amid seasonal demand and potential expansions to other age groups or regions. Overall, fiscal 2024 revenue reached $3.236 billion, reflecting a 52.75% year-over-year decline from 2023's $6.848 billion, driven by the expiration of advance purchase agreements and shifts to commercial markets.[79] Grant revenue, accounting for about 1.3% of totals, stems from government and philanthropic funding for research and development, including historical support from entities like the U.S. Biomedical Advanced Research and Development Authority (BARDA) for early mRNA platforms.[81] Collaboration and licensing revenue, roughly 1.2%, arises from partnerships such as the co-development agreement with Merck for an individualized neoantigen therapy (mRNA-4157/V940) targeting melanoma, which provides milestone payments but minimal ongoing contributions absent commercial breakthroughs.[81] For 2025, Moderna forecasts total revenue of $1.5 billion to $2.5 billion, anticipating persistent COVID-19 sales pressure offset partially by RSV uptake, with no significant new revenue streams from pipeline candidates until further approvals.[82]Profit Margins and Cost Structures
Moderna's gross profit margins peaked during the COVID-19 pandemic due to the scalability of its mRNA technology, which minimized variable production costs relative to high government-contracted pricing for Spikevax (mRNA-1273). In 2020, the gross margin reached approximately 96%, reflecting near-zero marginal costs after initial development, as mRNA synthesis avoids complex biological manufacturing processes typical of traditional vaccines.[83] This declined to 85% in 2021 and 71% in 2022 amid expanding production facilities and inventory write-downs, then fell sharply to 30% in 2023 as vaccine demand waned and cost of sales rose to represent a larger revenue share.[84] By 2024, gross margins recovered modestly to around 52-55%, supported by cost reductions in manufacturing, though still pressured by excess capacity and lower volumes.[85][86]| Year | Gross Margin (%) |
|---|---|
| 2020 | 96.03 |
| 2021 | 85.19 |
| 2022 | 70.62 |
| 2023 | 29.65 |
| 2024 | 52.50 |
Stock Performance and Investor Relations
Moderna, Inc. (NASDAQ: MRNA) completed its initial public offering on December 6, 2018, pricing shares at $23 and raising approximately $604 million. The stock traded modestly in its early years, reflecting the company's pre-revenue status focused on mRNA research, with a 28.09% gain in 2019.[92] The advent of the COVID-19 pandemic catalyzed explosive growth, as Moderna's mRNA-1273 vaccine candidate advanced rapidly under Operation Warp Speed. Shares surged 434.1% in 2020 and an additional 143.11% in 2021, peaking at $497.49 on August 10, 2021, driven by emergency use authorization, widespread adoption, and peak revenues exceeding $18 billion in 2021.[92] [93] Post-2021, performance reversed sharply amid declining vaccine demand, competition from updated formulations, and broader market skepticism toward biotech valuations without diversified revenue. Annual returns were -29.28% in 2022, -44.63% in 2023, -58.19% in 2024, and -35.69% year-to-date through October 2025.[92]| Year | Annual % Change |
|---|---|
| 2019 | +28.09% |
| 2020 | +434.1% |
| 2021 | +143.11% |
| 2022 | -29.28% |
| 2023 | -44.63% |
| 2024 | -58.19% |
| 2025 (YTD) | -35.69% |