Health Canada has approved Massachusetts-based clinical-stage biotechnology firm Moderna’s (MRNA) New Drug Submission (NDS-CV) for Spikevax, also known as COVID-19 Vaccine Moderna, for active immunization to prevent COVID-19 in individuals aged 12 years and above.
Following the announcement, shares of the company jumped 1.4% to close at $440.65 on Thursday. Moderna develops vaccines and therapeutics based on messenger ribonucleic acid (mRNA) for the treatment of immuno-oncology, cardiovascular diseases and infectious diseases.
The CEO of Moderna, Stéphane Bancel, said, “Health Canada’s approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax.”
The approval was based on clinical data from the Phase 3 COVE study of Spikevax, which enrolled over 30,000 participants in the U.S. (See Moderna stock chart on TipRanks)
On December 23, 2020, Health Canada authorized the vaccine under an interim order for individuals aged at least 18. On August 27, 2021, the government department expanded the interim order authorization for Spikevax to include adolescents who are at least 12 years old.
On September 15, Brookline Capital Markets analyst Leah R. Cann maintained a Buy rating on the stock with a price target of $468 (6.2% upside potential). The analyst expects the company to report earnings per share (EPS) of $6.93 in the third quarter.
Overall, the stock has a Hold consensus rating based on 4 Buys, 8 Holds and 2 Sells. The average Moderna price target of $328 implies 25.6% downside potential. Shares of the company have gained 549.1% over the past year.
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