Icon suspends COVID vaccine study after BARDA notice to sponsor

In a regulatory filing on Wednesday, Icon (ICLR) announced that the large-scale next generation COVID vaccine study that was highlighted on its earnings call on July 24 as restarted and actively enrolling has now had a stop work notice issued by BARDA to the sponsor. As a result, the sponsor has directed Icon to halt all screening and dosing activities for new subjects. Approximately half of the planned 10,000 subjects have already been enrolled and dosed in the trial and these participants will continue to be followed up per protocol, Icon said. The sponsor remains in discussions with BARDA as they work to determine next steps. “While the issuance of the stop work order will impact our revenue for the second half of 2025, there is no change to our financial guidance for the full year 2025,” Icon added.