Regulatory snag for palovarotene sinks Ipsen shares

Unresolved questions about data in Ipsen’s NDA for palovarotene have led the company to withdraw its application to FDA, delaying the approval process for what could be the first approved therapy for a rare bone disease.

Ipsen Group (Euronext:IPN; Pink:IPSEY) shed 13% of its value Friday, dipping €11.72 to €80.50 after withdrawing its NDA for the small molecule RARG agonist to treat fibrodysplasia ossificans progressiva (FOP). The company said May 28 that FDA had granted priority review to the application, with a PDUFA date of Nov. 30...