IPSEY News and Press, Ipsen SA ADR From 02/09/23

Ipsen S.A. press release ( OTCPK:IPSEY ): FY Non-GAAP EPS of €10.51. Revenue of €3.02B (+14.4% Y/Y). 2022 core operating margin of 36.9%, broadly in line with 2021. 2023 financial guidance : total-sales growth greater than 4.0% at CER1 ; core operat...

Summary The backbone of the Albireo is Bylvay, a product in a platform already approved in one indication and expected to be approved in two significant larger indications. Ipsen recognizes the huge potential and is offering $42 plus a $10 CVR to acquire Albireo. The deal is expected to...

Summary Albireo, Mirum Pharmaceuticals, Inc.'s only competitor in a billion-dollar market, is being acquired by Ipsen for up to $1.2 billion. The biggest value driver of Mirum is Livmarli, currently the only approved life-saving product in a rare pediatric disease market worth $500 mill...

A committee of the European Medicines Agency (EMA) declined to recommended Ipsen's ( OTCPK:IPSEY ) ( OTCPK:IPSEF )  drug palovarotene to treat a rare bone disorder. The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended not to grant marketing author...

Ipsen to request re-examination of CHMP opinion on palovarotene as a potential treatment for fibrodysplasia ossificans progressiva in E.U. FOP is an ultra-rare disease that continuously and permanently causes abnormal bone formation. 1 There are currently no disease-modifying treatment op...

Ipsen ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) presented full data from a phase 3 trial showing that its drug Onivyde helped improve overall survival (OS) and progression-free survival (PFS) in patients with a type of pancreatic cancer. The French drugmaker had initially reported ...

Investigational Onivyde ® (irinotecan liposome injection) in the NALIRIFOX treatment regimen demonstrated statistically significant improvements in overall survival and progression-free survival compared to nab-paclitaxel plus gemcitabine with a manageable safety profile 1 Result...

Transaction focused on Bylvay ® (odevixibat), the first-approved treatment in progressive familial intrahepatic cholestasis in U.S. and E.U., with potential in other rare diseases Acquisition aligned with Ipsen’s long-term strategy for expanding the scope of its Rare Disease p...

Summary In December 2022, MACK got positive clinical results for its Phase III clinical trial of Onivyde in first line pancreatic cancer. A $225m milestone from Ipsen will be triggered on approval, which corresponds to about $16.75 per basic share. After adjusting for NOLs, tax inte...

The U.S. FDA has declined to approve palovarotene developed by French pharma company Ipsen S.A. ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) to reduce abnormal bone formation in people living with ultra-rare disease fibrodysplasia ossificans progressiva (FOP). The FDA has communicated its decision...