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Inovio has announced positive interim clinical data of INO 4800 vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase I clinical trial cohorts. In addition, INO 4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government's Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine by January 2021.
Ardelyx announced the submission of a New Drug Application (NDA) for Ibsrela (tenapanor) to the FDA for the control of serum phosphorus (hyperphosphatemia) in adult patients with chronic kidney disease (CKD) on dialysis.
Intercept Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).