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The FDA has signed off Pardes Biosciences Inc's (NASDAQ:PRDS) Investigational New Drug (IND) application for PBI-0451 for COVID-19.
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- Pending further engagement with FDA and other regulators, the Company anticipates initiating global Phase 2/3 studies of PBI-0451 in SARS-CoV-2 infected patients in mid-2022.
- "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.," said Uri Lopatin, Chief Executive Officer.
- PB-0451 is currently under evaluation in a Phase 1 study in healthy volunteers in New Zealand evaluating the safety, tolerability, and pharmacokinetics of PBI-0451 after single and multiple ascending doses.
- Later this quarter, Pardes anticipates reporting data from this ongoing study at a scientific conference.
- Price Action: PRDS shares are up 6.54% at $11.08 during the market session on the last check Thursday.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.