Pliant Therapeutics PLRX received Fast Track designation for its lead asset PLN-74809 from the U.S. Food and Drug Administration (FDA) for the potential treatment of primary sclerosing cholangitis (PSC).
PLN-74809 is being investigated as part of the INTEGRIS-PSC Phase 2a clinical trial in patients with primary sclerosing cholangitis (PSC).
PSC is a rare, progressive liver disease of unknown origin, that frequently occurs in the setting of inflammatory bowel disease.
Éric Lefebvre, Chief Medical Officer, stated, ”Fast Track designation in primary sclerosing cholangitis represents a significant milestone in PLN-74809's development. PSC is a deadly disease with no FDA-approved Therapies. Fast Track designation underscores the urgent need for new therapeutic options to address PSC and other fibrotic diseases.”
The company expects topline data readout from the Phase 2a clinical trial in patients with PSC, during the first half of 2023.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Price Action : Pliant shares are trading over 2 percent higher at $20.17 on Thursday during pre-market session.
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