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News released late in to AM last evening

$Genfit(GNFT.US)$ Ipsen, Genfit Medicine Is Cleared by FDA for Rare Liver Disorder
The drug will be called Iqirvo, Ipsen said in a statement Monday. (Bloomberg) -- Ipsen SA and partner Genfit SA won US regulators’ clearance for the first new treatment option in eight years for patients with a rare liver disease.
The US Food and Drug Administration approved the medicine, elafibranor, for adults with primary biliary cholangitis, an autoimmune disease in which the bile ducts become inflamed and slowly destroyed. The drug will be called Iqirvo, Ipsen said in a statement Monday.
Ipsen’s medicine will likely vie with another potential new treatment from Gilead Sciences Inc. Gilead bought CymaBay Therapeutics this year for about $4.3 billion to gain the drug, seladelpar, which also awaits FDA approval. Both products got expedited regulatory review.
“We are ready to launch as soon as we get feedback,” Christelle Huguet, head of research and development at Ipsen, said in an interview. “The community is very excited. They really need new options.”
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