By Chris Wack
NRx Pharmaceuticals Inc. said it received the U.S. Food and Drug Administration's response to its Oct. 8 submission of updated manufacturing information for Zyesami.
The company said the completion of this review, without the imposition of any clinical hold by the FDA, enables it to distribute Zyesami, produced at commercial scale, under Good Manufacturing Practices for clinical trials and other future purposes approved in future regulatory actions.
NRx said it is looking forward to working with the FDA to complete the chemistry, manufacturing, and controls review that will ultimately be required for any potential drug approval.
Zyesami was previously manufactured for clinical trials purposes in handmade, 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.
NRx Pharmaceuticals shares were up 7%, to $6.46, in premarket trading.
Write to Chris Wack at chris.wack@wsj.com