IPSEF News and Press, Ipsen Sa Ord From 07/21/23

Positive opinion from Committee for Medicinal Products for Human Use (CHMP) based on Bylvay Phase III ASSERT clinical-trial data in Alagille syndrome (ALGS) Negative opinion from Committee for Orphan Medicinal Products (COMP) recommending not to maintain orphan drug designation for treatment ...

European Commission determines not to grant marketing authorization approval for palovarotene for fibrodysplasia ossificans progressiva (FOP) Decision follows negative opinion by the Committee for Medicinal Products for Human Use, in May No currently approved options available in the E.U....

2023-07-13 08:04:34 ET Intercept Pharmaceuticals ( NASDAQ: ICPT ) gained ~10% pre-market Thursday after H.C. Wainwright upgraded it to Buy from Sell, citing a novel drug combination the company is developing for an autoimmune disease called primary biliary cholangitis (PBC). ...

2023-07-10 19:36:22 ET Summary A PDUFA date of September 9, 2023 has been established for review of Motixafortide for Autologous Transplantation in Multiple Myeloma. Results from a phase 2 Columbia University investigator study, using Motixafortide in combination with LIBTAYO + SO...

2023-06-30 06:58:14 ET French biotech Genfit S.A. ( NASDAQ: GNFT ) added ~23% pre-market Friday after the company and its partner Ipsen ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) announced that a Phase 3 trial for elafibranor targeted at the rare liver disease primary biliary chola...

Trial met primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to placebo Elafibranor was well tolerated with a safety profile consistent with previous studies Results position elafibranor as a pote...

Advisory committee voted 10 for and 4 against that evidence from the Phase III MOVE study show palovarotene is an effective treatment in patients with the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP) Advisory committee further voted 11 for and 3 against on the benefits ...

Supplemental New Drug Application (sNDA) submission based on the NAPOLI 3 Phase III trial 1 Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with few treatment options currently available PARIS, FRANCE, 14 June 2023 &...

Supplemental New Drug Application (sNDA) submission based on the NAPOLI 3 Phase III trial 1 Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with few treatment options currently available PARIS, FRANCE, 14 June 2023 &...

Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related pruritus in 2021 Immediate U.S. commercial launch and availability for eligible patients ASSERT clinical study demonstrated efficacy of ...