Shares of Moderna (MRNA) rose 7.05% on Monday to close at $349.56 after the American pharmaceutical and biotechnology company disclosed positive topline data from the Phase 2/3 KidCOVE study.
Notably, the study evaluated mRNA-1273, its COVID-19 vaccine, in children 6 to under 12 years of age.
According to the interim analysis, a robust neutralizing antibody response was visible after two doses of mRNA-1273 at the 50 µg dose level, reflecting a favorable safety profile.
In the coming days, the company plans to submit the data to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators.
KidCOVE, a randomized, observer-blind, placebo-controlled expansion study, evaluates the safety, tolerability, reactogenicity and effectiveness of two 50 µg doses of mRNA-1273, administered to healthy children 28 days apart.
The study population was divided into three age groups (6 to less than 12 years, 2 to less than 6 years, and 6 months to less than 2 years).
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The CEO of Moderna, Stephane Bancel, said, “We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints. We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.” (See Moderna stock charts on TipRanks)
In a separate release, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the booster dose, Spikevax, the company’s vaccine against COVID-19. The dose can be administered at 50 µg for people aged 18 years and above, at least six months after completion of the primary vaccinations.
Following Moderna’s positive topline Phase 2/3 data on its COVID-19 vaccine for children from ages 6 to under 12, Piper Sandler analyst Edward Tenthoff reiterated a Buy rating on the stock with a price target of $445 (27.3% upside potential).
Overall, the stock has a Hold consensus rating based on 5 Buys, 5 Holds and 3 Sells. The average Moderna price target stands at $366.56 and implies upside potential of 4.86% to current levels. Shares have gained 96.8% over the past six months.
According to the new TipRanks Risk Factors tool, Moderna stock is at risk from three key factors: Tech & Innovation, Finance & Corporate, and Legal & Regulatory, which contribute 29%, 22% and 19%, respectively, to the total 98 risks identified for the stock. Under the Tech and Innovation risk category, MRNA has 28 risks, details of which can be found on the TipRanks website.