NasdaqGS:MRNABiotechs
FDA Flu Vaccine Rebuff Puts Moderna Respiratory Pipeline Timing In Focus
FDA declined to review Moderna's application for its mRNA based flu vaccine, citing issues with clinical trial design.
Moderna disputes the FDA's basis for refusal, saying study designs had previously been agreed with regulators.
The company plans to seek discussions with the FDA on next steps for its flu program and related respiratory vaccines.
For investors watching Moderna (NasdaqGS:MRNA), this regulatory setback arrives after a period of mixed share performance. The stock is at...