By Senad Karaahmetovic
Shares of Moderna (NASDAQ:MRNA) are trading about 5% lower in pre-market Tuesday after the biotech company suffered a setback on its first flu vaccine.
Moderna updated the public on its portfolio and said its mRNA-1010, the company's first vaccine candidate against influenza, is currently being evaluated in two Phase 3 trials. The second Phase 3 trial, which is being conducted in the Northern Hemisphere, reportedly "did not meet the statistical threshold necessary to declare early success."
As such, the independent Data and Safety Monitoring Board (DSMB) recommended that the trial continues with efficacy follow-up towards the next analysis. The board didn't identify any safety concerns.
"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, Chief Executive Officer of Moderna.
Elsewhere, the company also announced a new Lyme disease candidate while saying it forecasts to file for RSV (respiratory syncytial virus) approval this quarter. Moderna forecasts 2027 respiratory product sales between $8 billion and $15B.
Overall, Moderna expects six major vaccine product launches over the next few years.
"This framework is supported by $6 billion to $8 billion of additional research and development investments over the next few years," the company said in a press release.
Moderna shares are down nearly 11% year-to-date (YTD).