NRx Pharma up as FDA completes review on increased shelf life of COVID-19 drug

Hanall Biopharma

11/11/2021 15:20

** Shares of biopharma co  NRXP.O  up ~14.3% at $6.93
    ** U.S. FDA completed review of co's manufacturing of
Zyesami, its drug candidate for treating COVID-19 patients
facing respiratory problems, which allows NRXP to make drug at
commercial scale and at longer shelf life
    ** Co says Zyesami was previously made for trials in
handmade, 300-dose batches, with limited shelf life of 62 days
    ** FDA has now reviewed manufacturing process at batch size
of 10,000–100,000 doses, with shelf life of 150 days
 urn:newsml:reuters.com:*:nGNX1qrSkN
    ** This updated manufacturing information will become part
of co’s marketing application for Zyesami, which is currently
undergoing late-stage trials and, also support a renewed EUA
submission in future - NRXP
    ** Earlier this month, FDA declined an EUA for Zyesami
citing insufficient data  urn:newsml:reuters.com:*:nPnbbFPnxa
    ** Including session, stock has fallen 75.2% YTD 
    

 (Reporting by Oishee Majumdar in Bengaluru)
 ((oishee.majumdar@thomsonreuters.com;))