MRNA News & Events

Sanofi (SNY) said its protein-based non-mRNA COVID-19 vaccine Nuvaxovid demonstrated statistically significant lower systemic reactogenicity compared to mNEXSPIKE, Moderna's (MRNA) latest mRNA COVID-19 vaccine, across all pre-specified endpoints in the COMPARE study. The randomized, double-blind study enrolled 1,000 adults in the U.S. The study met its primary endpoint - the probability of experiencing at least one systemic reaction within seven days of vaccination - with statistical significance, with 91.6% of mNEXSPIKE recipients affected compared to 83.6% of Nuvaxovid recipients. The study also showed that 61.3% of mNEXSPIKE recipients experienced moderate-to-severe systemic symptoms versus 43.1% of Nuvaxovid recipients, and 58.7% of mNEXSPIKE recipients experienced moderate-to-severe local symptoms versus 38.7% of Nuvaxovid recipients. "In the COMPARE study, when side effects did occur with Nuvaxovid, they were less severe and shorter in duration compared to mNEXSPIKE. Severe systemic symptoms (body-wide reactions such as fatigue, headache, or fever) that prevent people from carrying out their normal daily activities were more than 50% less frequent with Nuvaxovid, affecting fewer than one in ten Nuvaxovid recipients compared to one in five mNEXSPIKE recipients, an analysis of the data showed," Sanofi said in a statement.

Moderna announced that the Company will present data from a Phase 1/2 study of mRNA-4359, an investigational cancer antigen therapy, at the American Association for Cancer Research Annual Meeting in San Diego, CA, on April 17-22, 2026. The presentation reports safety, efficacy and translational data from a Phase 2 dose-expansion cohort of the Phase 1/2 study, which evaluated mRNA-4359 + pembrolizumab as a first-line therapy in patients with locally advanced or metastatic melanoma. Among 12 participants, mRNA-4359 + pembrolizumab resulted in an overall response rate of 83%, with two patients achieving a complete response and eight achieving a partial response, as well as a disease control rate of 92%. The median time to response was six weeks. Responses occurred across baseline tumor PD-L1 expression categories, with an ORR of 88% among patients with PD-L1+ tumors, and 67% among patients with PD-L1- tumors. Consistent with mRNA-4359's mechanistic rationale, antigen-specific T-cell responses and novel expanded T-cell receptor clonality was observed in all patients with evaluable samples. mRNA-4359 + pembrolizumab demonstrated a manageable safety profile, with no new immune-related adverse events. "This study evaluating mRNA-4359 + pembrolizumab as a first-line treatment option reflects our ambition to demonstrate the potential of mRNA technology throughout a cancer patient's journey. While conducted among a small patient population, we are encouraged by the high response rates and mechanistic translational results," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "We look forward to further evaluating the potential of mRNA-4359 in patients with melanoma."

Bullish flow in Moderna (MRNA), with shares up 56c, or 1.11%, near $51.52. Options volume relatively light with 19k contracts traded and calls leading puts for a put/call ratio of 0.57, compared to a typical level near 0.82. Implied volatility (IV30) is higher by 0.9 points near 76.8,and above the 52wk median, suggesting an expected daily move of $2.49. Put-call skew flattened, suggesting a modestly bullish tone.Looking ahead: Moderna (MRNA) will report earnings after the close on None.Option markets are pricing in a 50% probability of a move greater than 0.0% or $0.00.