Altimmune (NASDAQ: ALT) said on Wednesday evening the US Food and Drug Administration (FDA) has put a clinical hold on its Investigational New Drug (IND) application for AdCOVID, a single-dose intranasal COVID-19 vaccine candidate.
The FDA requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data.
Altimmune said it responded to the agency’s letter but did not anticipate a significant impact on the overall clinical development timeline.
“We look forward to working with the FDA and will continue preparing to commence our planned Phase 1 clinical trial of AdCOVID,” commented Vipin K Garg, President and CEO of Altimmune.
The company’s shares are down 9.59% premarket at $11.41 following the news. They closed Wednesday’s session at $12.62.