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CymaBay and Genfit have been positioning their failed NASH candidates, both PPAR agonists, for approval in second-line primary biliary cholangitis. Analysts call both approvable, but say CymaBay’s drug has a better overall profile.
Private Company Edition: The €740m ($806.5m) Gilde Healthcare Venture&Growth VI Fund will back companies in Europe and North America. Among recent financings, VectorY raised a €129m ($138m) series A round, EyeBio expanded its series A to $130m and MBrace raised an $85m series B.
Sotatercept, marstacimab, elafibranor, eplontersen, mirvetuximab soravtansine, troriluzole and tiratricol are among the latest products that the European Medicines Agency has started reviewing for potential EU marketing approval.
The French company plans to refile Bylvay for Alagille syndrome under a new brand name after the EMA's Committee for Orphan Medicinal Products said the drug did not meet its 'significant benefit' criteria.
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