NRx Pharmaceuticals Gets FDA Review for Zyesami Manufacturing
November 11 2021 - 8:40AM
Dow Jones News
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
(END) Dow Jones Newswires
November 11, 2021 08:25 ET (13:25 GMT)
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