FDA Approves Leucovorin for Rare CFD-FOLR1 Disorder; Price Targets Raised to $18–$20
The FDA approved a generic leucovorin indication for cerebral folate deficiency in CFD-FOLR1 patients with developmental delays and seizures. UBS, Canaccord and Citi lifted price targets to $19, $18 and $20 after Kenvue’s Q4 revenue of $3.78B beat forecasts and all segments grew.
1. Expanded FDA Approval for Cerebral Folate Deficiency
The FDA approved the expanded use of leucovorin calcium tablets to treat cerebral folate deficiency in adult and pediatric patients with confirmed FOLR1 gene variants. This genetic disorder causes developmental delays, movement disorders and seizures, making leucovorin the first targeted therapy and enabling generic manufacturers to include the new indication on labeling.
2. Analyst Upgrades and Price Target Raises After Q4 Beat
On February 18, UBS raised its Kenvue price target to $19 from $17 while maintaining a neutral rating, Canaccord lifted its target to $18 and Citi to $20. These actions followed fourth-quarter revenue of $3.78 billion, a $90 million beat on estimates, and marked year-over-year growth across all three business segments.