Moderna announced on Jul. 31 that it is maintaining its up to 10% revenue growth target for the year, despite a setback in its late-stage norovirus vaccine trial. The company cited strong international vaccine sales as a key factor supporting this outlook.
The Phase 3 interim analysis of Moderna’s norovirus candidate, mRNA-1403, did not meet statistical significance, according to the company's earnings report released Friday. The ongoing NOVA 301 study has enrolled nearly 38,000 participants and will remain blinded as recruitment continues for an additional cohort. President Stephen Hoge said during a call with investors that details about the statistical analysis plan have not yet been shared due to the trial's blinded status. “The epidemiology of the primary endpoint cases has been a little bit slower coming,” Hoge said. “Some of that in the first season for that trial was the result of a unique outbreak of a different set of strains of norovirus.”
Hoge explained that Moderna conducted an interim analysis after the second season and is preparing to include data from a third season in winter this year. “We know we will need additional cases from a further cohort to strengthen that statistical analysis,” he said. He added, “This has happened with other vaccines in the past. If you think about flu vaccines, they often have to do multiple season studies to accrue sufficient cases.”
In addition to developments with its norovirus program, Moderna is deferring further development decisions on its investigational asset mRNA-3705 for methylmalonic acidemia until results are available from an ongoing Phase 1/2 study. The company also ended development of an inhaled mRNA candidate for cystic fibrosis developed with Vertex Pharmaceuticals due to tolerability issues observed in early-phase trials.
Moderna reported quarterly revenue at $145 million, surpassing expectations largely due to international sales of COVID-19 vaccines Spikevax and mNexspike; U.S. and global revenues are expected to be evenly split this year. Chief Financial Officer Jamey Mock said on Friday’s call, “I think the biggest variable comes down to the U.S.… We have provided for a vaccination rate decline, particularly in the U.S., and so, the biggest upside swing is if it is not as big a decline as we’ve projected.”
Looking ahead, Moderna awaits potential approval by Aug. 5 for its seasonal flu vaccine mFLUSIVA following unanimous positive support from an FDA advisory committee after initial concerns over trial design were resolved earlier this year.
