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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...
The CRL is related to the U.S. FDA’s previous request for additional information on palovarotene clinical trial data Ipsen anticipates responding to the request in the first quarter of 2023 Regulatory News: The U.S. Food and Drug Administration (FDA) issued a Complete Res...
The trial did not meet its primary endpoint of overall survival (OS) The safety profile of the combination of cabozantinib and atezolizumab was consistent with the known safety profiles for each single agent The clinical trial results will be presented at a future medical meeting ...
Ipsen ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) said its drug Onivyde met the main goal of overall survival in patients with pancreatic cancer in a phase 3 trial. The study, dubbed NAPOLI 3, evaluated Onivyde (irinotecan liposome injection) plus the ...
Trial met its primary endpoint with Onivyde ® (irinotecan liposome injection) in the NALIRIFOX treatment regimen showing statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine regimen Study met key secondary endpoint of progr...
The following slide deck was published by Ipsen S.A. in conjunction with their 2022 Q3 earnings call. For further details see: Ipsen S.A. 2022 Q3 - Results - Earnings Call Presentation
Summary MACK has a $225m milestone if its drug Onivyde works in first-line pancreatic cancer (already approved in second-line). The stock has been badly misvalued because the vast majority of pancreatic cancer drugs are targeted therapies that fail in the clinic. But the activ...
Ipsen S.A. press release ( OTCPK:IPSEY ): Q3 Revenue of €774.8M (+16.0% Y/Y). Ipsen has confirmed its financial guidance for FY 2022 :Total-sales growth greater than 7.0%, at constant exchange rates. Based on the average level of exchange rates in September...
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, today presents its sales performance for the year to date and the third quarter of 2022. Sales summary 1 Highlights – Total-sales growth in the yea...
Regulatory News: Disclaimer: Intended for international media and investor audiences only Ipsen (Euronext: IPN; ADR: IPSEY) reports that the U.S. Food and Drug Administration (FDA) has today announced its decision to postpone the planned Endocrinologic and Metabolic Drugs Adviso...
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Ipsen and Skyhawk Therapeutics announce RNA targeting research collaboration in rare neurological diseases Canada NewsWire Ipsen enters into an option agreement to receive exclusive global rights to two candidates pursued under the collaboration Following development ...
Marengo Therapeutics Announces First Drug Candidate Nomination from Oncology Collaboration with Ipsen PR Newswire A Novel TCR Vβ bifunctional selective T cell activator molecule for solid tumor treatment Marengo to receive an associated milestone payment a...
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