NRx Pharmaceuticals (NASDAQ: NRXP) saw its shares shoot higher Friday, one day after word that it has validated the first commercial formulation of ZYESAMI™ (aviptadil) for intravenous use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions.
The company, based in Radnor, Pa., also announced that simultaneously, it had achieved a 30-to-50-fold increase in its manufactured lot size of aviptadil, with a concurrent 90% reduction in the cost of its peptide supply. These two developments position NRx to potentially deliver millions of doses of ZYESAMI as potential regulatory approvals are obtained in various regions worldwide.
Said CEO Jonathan Javitt, “When we began developing aviptadil for treatment of COVID-19, we discovered that the original RLF-100 formulation and manufacturing method had only a few weeks of stability, leaving hospitals unable to stock the investigational medicine in pharmacies, and leaving aviptadil out of consideration for national strategic stockpiles. Moreover, the high cost of peptide and an inability to manufacture more than 100 grams a month limited the commercial utility of aviptadil,
“We have now turned the corner and can produce both the aviptadil peptide and finished medicine in million dose quantities. We have also developed and validated the first modern chromatography assays required to ensure the purity and stability of the drug product. The new formulation method and high-speed manufacturing process adapts to the fragile nature of vasoactive intestinal peptide.”
NRXP shares jumped $2.29, or 13.9%, to $18.74.