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Shares of Moderna (NASDAQ:MRNA) are trading nearly 6% in pre-market Friday after the company presented interim Phase 3 results for its flu vaccine candidate – mRNA-1010.
According to the company, Interim results demonstrated “superiority on seroconversion rates for A/H3N2 and A/H1N1, as well as superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1.” However, shares were hit on the fact that the flu vaccine didn’t meet endpoints for the influenza B/Victoria- and B/Yamagata-lineage strains.
“While we did not achieve non-inferiority for the Influenza B strains which are more frequent in younger populations, we have already updated the vaccine that we believe could improve immune responses against Influenza B and will seek to quickly confirm those improvements in an upcoming clinical study thanks to the agility of our mRNA platform,” said Stephen Hoge, M.D., Moderna’s President.
Goldman Sachs analysts said the “mixed” results will raise questions of the regulatory path for mRNA-1010. Overall, the flu vaccine showed a “well-tolerated profile.”
“We emphasize that A strains account for >99% of positive flu tests by clinical laboratories this season and thus the more positive profile against these strains may bode well into the interim analysis from the separate Ph3 efficacy study expected by the end of 1Q,” the analysts wrote in a note.
Brookline Capital Markets analysts said the results were supportive of broker’s outlook. The analysts believe this vaccine candidate could prove to be “highly effective in the older population, which is primarily affected by Influenza A.” Moderna’s influenza vaccine could enter the market in 2024, they wrote in a client note.
“We estimate with a conservative market share of 14% of seasonal flu, mRNA-1010/ mRNA1020/ mRNA-1030, could result in 2030 sales of $1.46 billion. Importantly, we believe the bigger impact from potential seasonal flu vaccines, is for their combination with higher value vaccines, and therefore increasing their value and resulting in higher market share than we currently estimate,” the analysts said.
Moderna shares are down 4% year-to-date (YTD) based on yesterday’s closing price.
