Moderna MRNA shares are trading lower on Tuesday after the company said its first influenza candidate, mRNA-1010, did not accrue sufficient cases at the interim efficacy analysis to declare early success in the Phase 3 Northern Hemisphere efficacy trial and the independent DSMB recommended continuation of efficacy follow-up.
mRNA-1010 is the Company's first vaccine candidate against influenza, which is being developed in adults. mRNA-1010 is currently being evaluated in two Phase 3 trials. The first Phase 3 trial (P301) of mRNA-1010 was conducted in the Southern Hemisphere to assess its safety and immunogenicity compared to a licensed flu vaccine. The trial found that mRNA-1010 has an acceptable safety and tolerability profile, and the independent Data and Safety Monitoring Board (DSMB) did not raise any safety concerns during the trial.
The second Phase 3 trial (P302) of mRNA-1010 is currently being conducted in the Northern Hemisphere. The independent DSMB has completed the first interim analysis of efficacy and recommended that the trial continue with efficacy follow-up towards the next analysis as mRNA-1010 did not meet the statistical threshold required for early success. However, the DSMB did not identify any safety concerns during the trial. The trial is ongoing, and blinded follow-up for safety and efficacy is still in progress.
"With mRNA-1010, our first investigational vaccine against seasonal flu, we are encouraged by the consistently strong immunogenicity results against influenza A, and titers consistent with non-inferiority against influenza B strains in the most recent Phase 3 trial,” said Stéphane Bancel, CEO of Moderna.
Moderna is a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines.
MRNA Price Action: Moderna has a 52-week high of 217.2 and a 52-week low of $115.06.
Moderna shares are down 4.33% at $153.23 at the time of writing, according to Benzinga Pro.
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