Moderna, Inc. News
Moderna, Inc., a biotechnology company, discovers, develops, and commercializes messenger RNA therapeutics and vaccines for the treatment of infectious diseases, immuno-oncology, rare diseases, autoimmune, and cardiovascular diseases in the United States, Europe, and internationally. Its respiratory vaccines include COVID-19, flu, respiratory syncytial virus, Endemic HCoV, and hMPV+PIV3 vaccines; latent vaccines comprise cytomegalovirus, epstein-barr virus, herpes simplex virus, varicella-zoster virus, and human immunodeficiency virus vaccines; and public health vaccines consists of Zika and Nipah vaccines. The company also offers systemic secreted and cell surface therapeutics; cancer vaccines, such as personalized cancer, KRAS, and checkpoint vaccines; intratumoral immuno-oncology products; localized regenerative, systemic intracellular, and inhaled pulmonary therapeutics. It has strategic alliances and collaborations with AstraZeneca; Merck; Vertex Pharmaceuticals Incorporated; Vertex Pharmaceuticals (Europe) Limited; Chiesi Farmaceutici S.p.A.; Metagenomi, Inc.; Carisma Therapeutics, Inc.; CytomX Therapeutics; Defense Advanced Research Projects Agency; Biomedical Advanced Research and Development Authority; Institute for Life Changing Medicines; and The Bill & Melinda Gates Foundation. The company was formerly known as Moderna Therapeutics, Inc. and changed its name to Moderna, Inc. in August 2018. Moderna, Inc. was founded in 2010 and is headquartered in Cambridge, Massachusetts.
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9d
Moderna LNP Settlement, FDA Sets Flu PDUFA Date Q3
- Moderna disclosed a major settlement resolving lipid‑nanoparticle patent litigation and secured FDA acceptance for its seasonal flu mRNA vaccine application with a PDUFA date in August 2026. Both developments triggered sharp stock moves and reduce key execution risks as the company pivots beyond COVID‑19 revenues.
16d
Moderna Rally: FDA Reversal, Q4 Strength & Risks!!
Moderna (MRNA) saw a near-term rebound after the FDA agreed to review its mRNA flu shot application and the company posted stronger-than-expected Q4 results alongside aggressive cost cuts. Near-term catalysts include a March patent trial, oncology readouts later in 2026, and international regulatory reviews for combination vaccines.
23d
Moderna FDA Reversal Spurs mRNA-1010 Rally Shares!
Moderna's shares jumped after the FDA reversed a refusal-to-file for its seasonal mRNA flu vaccine, mRNA-1010. Analyst target hikes, leadership shifts toward oncology, and cost cuts support the rally. This article summarizes the concrete regulatory, financial, and strategic developments that are driving near-term investor sentiment for MRNA.
20 Feb at 10:48
FDA Reopens Review; Moderna's mRNA-1010 Boost Now!
Moderna regained regulatory momentum after the FDA agreed to review its mRNA-1010 seasonal flu vaccine, triggering a notable share uptick. Combined with quarterly financial guidance and an intensified oncology push, these concrete developments create near-term catalysts for MRNA stock.
13 Feb at 10:48
Moderna Shock: FDA Blocks Flu Shot; Norges Buy Now
Moderna (MRNA) faced a major regulatory setback this week when the FDA issued a refusal-to-file for its mRNA flu vaccine mRNA-1010, citing comparator issues in elderly trials. Counterbalancing that blow, Norges Bank opened a large new position in Moderna and the company reports Q4 2025 results today—events that together create acute near-term volatility and longer-term pipeline inflection points.
06 Feb at 10:48
Moderna Surges on Melanoma Data, Hits 52-Week High
Moderna (MRNA) rallied after preliminary 2025 financials and compelling five-year Phase 2 melanoma results for its personalized cancer vaccine (intismeran) combined with Keytruda. The company reported stronger-than-expected revenue, trimmed expenses, and an increased cash runway, while the clinical readout showed a 49% reduction in recurrence or death in high-risk melanoma. The twin catalysts pushed MRNA to new 52-week highs but left analysts cautious on valuation and execution risk.
30 Jan at 10:48
MRNA Spike: Five-Year Melanoma Win Drives Moderna!
Moderna (MRNA) surged after five-year Phase 2b melanoma data showed a 49% recurrence risk reduction for its personalized mRNA cancer therapy with Merck. Simultaneous R&D cuts, a delayed cash break-even to 2028, and a pause on new infectious-disease vaccine studies reshape strategy and investor focus.