Valneva SE
VLA15
Lyme disease
Date
TBD
FDA decision · Date TBD estimated
What's at stake
The FDA's approval decision on VLA15 for Lyme disease is due Date TBD. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 6-K
verified 12h ago
“Subject to positive Phase 3 results, Pfizer intends to submit a Biologics License Application (BLA) to the U.S. FDA and Marketing Authorization Application (MAA) to the European Medicines Agency”