NRx Pharma's COVID-19 Candidate Receives FDA Review For Manufacturing Information

NRx Pharmaceuticals Inc NRXP has received the FDA's response to NRx's submission of updated manufacturing information for Zyesami (aviptadil).
The completion of this review, without the imposition of any clinical hold by the FDA, enables NRx to distribute Zyesami for clinical trials and other future purposes approved in future regulatory actions.
NRx looks forward to working with the FDA to complete the chemistry, manufacturing, and controls (CMC) review.
Zyesami was manufactured for trials purposes in 300 dose batches, with a limited shelf life of 62 days.
The FDA has now reviewed a GMP manufacturing process at a batch size of 10,000 – 100,000 doses with a current shelf life of 150 days and identified no basis for a clinical hold.
Related Link: NRx Pharma Stock Nosedives As FDA Strikes Off Its COVID-19 Drug Hopeful.
Price Action: NRXP shares are up 5.36% at $6.39 during the market session on the last check Thursday.