Moderna, Inc. reports developments in mRNA medicines, including commercial vaccines, investigational respiratory vaccines, oncology programs and rare-disease candidates. News commonly covers regulatory authorizations and agency interactions for products such as Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, as well as clinical data for seasonal influenza, pandemic influenza and cancer immunotherapy programs including intismeran autogene and mRNA-4359.
Company updates also include quarterly financial results, revenue mix, expense actions, strategic partnerships, scientific meeting presentations and intellectual-property matters tied to Moderna's infectious disease portfolio and broader mRNA technology platform.
Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) reported positive topline Phase 3 results from the global INTerpath‑001 trial in completely resected stage IIB‑IV cutaneous melanoma. The combination of intismeran autogene (V940/mRNA‑4157), an individualized mRNA neoantigen therapy, plus KEYTRUDA met the primary endpoint of recurrence‑free survival and a key secondary endpoint of distant metastasis‑free survival versus KEYTRUDA alone.
According to the companies, this is the first positive Phase 3 readout for an individualized neoantigen therapy and for an mRNA‑based cancer therapy, and the first Phase 3 trial to show a clinically meaningful improvement over KEYTRUDA monotherapy in the adjuvant melanoma setting. The study enrolled 1,137 patients randomized 2:1 to intismeran+KEYTRUDA versus KEYTRUDA alone, with dosing for up to about one year. Safety for both agents was consistent with prior studies, with no new safety signals observed. The trial will continue to assess additional secondary endpoints, including overall survival, and Merck and Moderna plan to present the data at an international medical meeting and to discuss potential regulatory submissions.
Moderna (NASDAQ:MRNA) received full U.S. FDA approval for mFLUSIVA (mRNA‑1010), an mRNA-based seasonal influenza vaccine indicated for adults 50 years and older. This is Moderna’s fifth approved product globally and fourth FDA-approved product, and the first mRNA flu vaccine approved in the U.S.
Approval in adults 50–64 is supported by a randomized Phase 3 trial (40,805 participants) evaluating safety, reactogenicity and relative vaccine efficacy versus a standard-dose comparator. Use in adults 65+ is under accelerated approval based on immunogenicity data from a separate randomized trial (2,992 participants), with clinical benefit to be confirmed postmarketing. The Phase 3 program showed an acceptable safety profile with no new safety concerns identified. Moderna expects U.S. supply for eligible populations in the 2026–2027 respiratory virus season and has regulatory reviews underway in the EU, Canada and Australia.
Moderna (NASDAQ:MRNA) reported that Health Canada has authorized, and first participants have been vaccinated in, a Phase 1 clinical trial in Canada of mRNA-1469, its investigational mRNA vaccine candidate to prevent Bundibugyo ebolavirus (BDBV) disease, a strain of Ebola with no licensed vaccines.
According to Moderna, the first-in-human study (NCT07737717) at three Canadian sites will assess safety, tolerability and immunogenicity in about 80 healthy adult participants. The program is part of an expanded collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed up to US$50 million for preclinical work, Phase 1, and scaled manufacturing of additional clinical doses to support rapid progression to later-stage trials if results justify. Moderna states that, under its CEPI agreement, it will make at least 500,000 doses available for timely supply to low- and middle-income countries at access pricing if the vaccine is licensed.
Moderna (NASDAQ:MRNA) reported second quarter 2026 revenue of $145 million, slightly above $142 million a year earlier, with a GAAP net loss of $(782) million and GAAP EPS of $(1.97). Cost of sales fell 22% year over year, R&D declined 7%, and SG&A decreased 6%.
Cash, cash equivalents and investments totaled $6.9 billion at June 30, 2026, before a $950 million litigation payment in July. For 2026, Moderna targets up to 10% revenue growth, has lowered expected cost of sales to $1.7 billion and R&D to $2.9 billion, and now projects year-end cash and investments of $4.7–$5.2 billion.
According to Moderna, commercial progress included a COVID vaccine collaboration in Brazil, an EU joint procurement contract for up to 24 million mRESVIA doses, and multiple regulatory approvals for mRESVIA, mNEXSPIKE and combination vaccine mCOMBRIAX. A U.S. PDUFA date of August 5, 2026 is set for flu vaccine candidates mFLUSIVA and mRNA‑1010, while norovirus candidate mRNA‑1403 did not meet statistical criteria for early success at an interim Phase 3 analysis.
Moderna (NASDAQ:MRNA) announced dosing of the first U.S. participant in its Phase 1 trial of mRNA-4200, an investigational tumor-targeted cancer antigen therapy for adults with advanced or metastatic solid tumors. mRNA-4200 encodes seven antigens shared across patients and tumor types to help induce and expand T-cell responses against selected tumor targets.
The first dose was given at START Mountain Region in Salt Lake City, part of The START Center for Cancer Research network. The Phase 1 study (NCT06880549) is an open-label, multicenter, dose-escalation trial evaluating safety and tolerability of mRNA-4200 with checkpoint inhibitor therapy. mRNA-4200 is Moderna’s third off-the-shelf cancer antigen therapy and was developed with Immatics, using its XPRESIDENT® target discovery and XCUBE® bioinformatics and AI platforms.
Moderna (NASDAQ:MRNA) will hold a live conference call and webcast at 8:00 a.m. ET on Friday, July 31, 2026 to report its second quarter 2026 financial results and provide a corporate update.
The live and archived webcasts will be available in the Investors section of Moderna's website.
Moderna (NASDAQ:MRNA) appointed Michael McDonnell to its Board of Directors, effective July 8, 2026. He will also serve on the Board’s Audit Committee.
McDonnell brings over 35 years of financial leadership, including CFO roles at Biogen, IQVIA, Intelsat, MCG Capital and EchoStar, plus advisory work with Goldman Sachs Asset Management and board service at Merit Medical Systems and Baxter International.
Moderna (NASDAQ:MRNA) used its June 25, 2026 Science Day to outline how its mRNA platform supports three commercial franchises and a broad early-stage pipeline.
Updates covered Horizon 2 oncology and multiple sclerosis programs, validation of a T-cell engager modality, and a new in vivo CAR-T program for autoimmune diseases.
Moderna (NASDAQ:MRNA) reported that the FDA's Vaccines and Related Biological Products Advisory Committee voted 9-0 that the benefits of mRNA-1010, its investigational seasonal influenza vaccine, outweigh the risks in adults 50–64 and 65+. Phase 3 data and a consistent safety profile support its Biologics License Application, with a U.S. PDUFA goal date of August 5, 2026 and parallel reviews in the EU, Canada and Australia.
Moderna (Nasdaq:MRNA) will host its Investor Event - Science Day at 9:00 a.m. ET on June 25, 2026.
The event will review Moderna's research and early development programs, showing how its mRNA platform, combined with AI and robotics, is driving innovation and potential expansion into new therapeutic areas. A live webcast and a replay (for at least 30 days) will be available on the Moderna investor website.