PRDS - Pardes rises 6% as FDA clears COVID-19 oral drug PBI-0451 to enter clinical trials

The U.S Food and Drug Administration (FDA) cleared Pardes Biosciences' (NASDAQ:PRDS) investigational new drug (IND) application for its oral antiviral PBI-0451 to enter trials for treating and preventing of SARS-CoV-2 infections. “The clearance of our IND for PBI-0451 enables us to proceed with the initiation of additional Phase 1 clinical trials for PBI-0451 in the U.S. Pending additional engagement with FDA and other regulators, we anticipate initiating our global Phase 2/3 studies of PBI-0451 in SARS-CoV-2 infected patients in mid-2022,” said CEO Uri Lopatin. PB-0451 is currently under evaluation in a phase 1 dose escalation study in healthy volunteers in New Zealand. The company expects to report data from this ongoing study at a scientific conference later this quarter. PRDS +5.77% premarket to $11.0

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Pardes rises 6% as FDA clears COVID-19 oral drug PBI-0451 to enter clinical trials