OM:BIOA BBiotechs
FDA Leqembi Review Extension Tests BioArctic’s Rich Valuation And Momentum
FDA has extended its review of BioArctic and Eisai's Leqembi Iqlik for early Alzheimer’s disease.
The extension follows a request for additional information with no approvability concerns flagged by the FDA.
The decision relates to a once weekly subcutaneous formulation and affects ongoing commercialization plans in new regions.
For BioArctic (OM:BIOA B), this regulatory step comes at a time when the stock is trading at SEK332.0 and has a value score of 1. The share price performance has...