Moderna Tumbles on Delay of Product Launch

Moderna (NASDAQ:MRNA) took lost ground Tuesday after the company said it’s delaying its flu vaccine due to a lack of enrolled cases in a late-stage trial. The news comes after a company spokesperson told the media on Monday that Moderna hopes to release a slew of new vaccines that target cancer, heart disease as well as other yet-to-be confirmed conditions by 2030.

Moderna noted that it has developed an update to mRNA-1010 which is expected to have improved immunogenicity against influenza B strains and announced plans to start a confirmatory phase 3 trial this month.
Earlier in February, the company had reported mix results for the flu shot from a phase 3 trial called P301, which was carried out in the Southern Hemisphere. The vaccine had not shown non-inferiority for either goals of seroconversion rates and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strains.

On Tuesday, Moderna provided updates on its clinical programs, including the second Phase 3 trial, dubbed P302, of mRNA-1010 conducted in the Northern Hemisphere to evaluate safety and non-inferior efficacy compared to a licensed flu vaccine.

The company said that an independent Data and Safety Monitoring Board completed its first interim analysis of efficacy and informed that mRNA-1010 did not meet the statistical threshold required to declare early success and recommended that the study continue with efficacy follow-up towards the next analysis.

Moderna said that the P302 study did not pre-specify success criteria for immunogenicity goal.

The company said that it has five influenza vaccine candidates in clinical development.

MRNA shares dumped $8.39, or 5.2%, to $151.76.

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