Genfit
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Genfit spreads its bets in a rare liver disease with buyout of Phase 2-ready biotech
Liver disease remains the focus of Genfit, despite a high-profile clinical trial failure in the fatty liver disease NASH. The company is building out its pipeline by acquiring Versantis, a clinical-stage biotech whose most advanced drug candidate brings a novel approach to treating a deadly chronic liver disease complication that has no FDA-approved therapies.
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Ipsen gets rights to failed Genfit NASH drug, now in Phase 3 for rare liver disease
Ipsen is paying €120 million up front to acquire global rights to elafibranor, a Genfit drug that fell short as a treatment for NASH, but is currently in Phase 3 testing in another liver disease, primary biliary cholangitis. Meanwhile, Genfit is adding an early-stage drug candidate to its own pipeline via a separate transaction.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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French biotech Genfit shifts gears after Phase III NASH failure
The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.
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Genfit’s drug flops in Phase III, joining graveyard of NASH failures
The French drugmaker said Monday that its Phase III study of elafibranor failed to meet its primary and key secondary endpoints. Analysts remarked that this extends the lead of the drug likely to get the first NASH approval, Intercept’s obeticholic acid.
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Genfit delays data from Phase III study of NASH drug as it awaits FDA feedback
Shares of the French company fell more than 3% Friday following news it would delay unblinding data from the Phase III study of elafibranor. This marks the second delay of data since September and means it will likely be announced in the second quarter rather than the first.
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The top biopharma companies targeting NASH
These are four companies that currently have drugs in Phase III development for nonalcoholic steatohepatitis or have them under Food and Drug Administration review.
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Genfit CEO says company emphasizes patient access as it considers price for its NASH drug
In an interview at the BIO CEO & Investor Conference in New York Monday, CEO Pascal Prigent said barriers to access rather than reimbursement represent the biggest concern for NASH drugs like elafibranor. As a ballpark estimate, a list price in the $10,000 range is possible.
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Genfit scores seventh positive data safety monitoring board opinion for Phase III NASH trial
In a note to investors, an analyst wrote that the news bodes well for the company’s anticipated Phase III readout for the drug, elafibranor. Another company, Intercept Pharmaceuticals, said the FDA had accepted its application for its investigational NASH drug, obeticholic acid.
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Genfit makes $135M debut on Nasdaq
The French company, developing a drug to treat nonalcoholic steatohepatitis, or NASH, announced the pricing of its shares at $20.32 apiece.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Genfit, developing drugs for NASH, to trade on Nasdaq
The company, one of several developing drugs for the growing fatty liver disease, said in an SEC filing that it would sell its shares at $26.33 apiece.
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Three major variables that could derail the dash to NASH
From clinical trial saturation to a suspiciously strong placebo effect: Here are some of the major challenges facing biopharma companies in pursuit of the first FDA-approved therapy for non-alcoholic steatohepatitis (NASH).
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
