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Latest BTD approval

  1. hottod

    3,229 Posts.
    Intercept Pharmaceuticals (ICPT: Nasdaq) is the latest company to be granted Breakthrough Therapy Designation from the FDA.

    Intercept announced after close of Thursday trade that breakthrough designation had been granted for its investigational product obeticholic acid (OCA) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.

    Breakthrough therapy designation for OCA was based on clinical efficacy and safety data from two placebo-controlled, Phase 2 clinical trials of OCA, one in 64 patients and the second in 283 patients. Intercept will now be working closely with the FDA to finalise design of its Phase 3 program for the drug.

    ICPT's stock price rose $49.31 (28.89%) in post-market trade, adding just over US$1 billion to Intercept’s market capitalisation.



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