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Seladelpar NDA Submitted to FDA for Primary Biliary Cholangitis
The New Drug Application submission is supported by data from a pair of phase 3 studies, a long-term open-label study, and prior phase 2 studies. Cymabay has also requested Priority Review of the NDA.
Klara dickinson
Drug administration
Cymabay therapeutics
New drug application
Priority review
Breakthrough therapy designation
Cymabay submits new drug application
Primary biliary
Primary biliary cholangitis including pruritus
Patients without cirrhosis
With compensated
Improves markers
Cymabay therapeutics announces publication
Results from
Primary biliary cholangitis
Food and drug administration
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