- The stock price of NRx Pharmaceuticals Inc (NASDAQ: NRXP) increased by over 80% during intraday trading. This is why it happened.
The stock price of NRx Pharmaceuticals Inc (NASDAQ: NRXP) increased by over 80% during intraday trading. Investors responded positively to NRx Pharmaceuticals announcing today 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. And NRx has 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 2 developments position NRx to potentially deliver millions of doses of ZYESAMI as potential regulatory approvals are obtained in various regions worldwide.
As the Delta variant and more threatening newer mutations of the coronavirus are continuing to erode the immunity created by first-generation vaccines, NRx is now in active discussion with national health ministries and regulators regarding Emergency Use Authorization for ZYESAMI (aviptadil). And the new formulation allows for immediate shipping worldwide, upon potential EUA approval.
The successful new formulation and manufacturing scaleup of ZYESAMI allows NRx to relaunch its Expanded Access and Right to Try programs as it continues to seek Emergency Use Authorization in the United States. And these programs are designed to afford patients at highest risk of death from COVID-19, and who have no other therapeutic options, the ability to access ZYESAMI on an investigational basis.
“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.”
— Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx
“Twenty years ago, Dr. Sami Said formulated the first doses of aviptadil by hand in a hospital pharmacy. We began this project a year ago, with 9 days of stability and an ability to manufacture about 100 doses of medicine each day. We learned through significant study and testing that the important biologic activity of this small peptide is accompanied by a fragile molecular structure that is destroyed by standard high-volume pharmaceutical manufacturing processes. Fortunately, we and our manufacturing partners have reached a greater level of commercial manufacturing, just as the pandemic seems poised to enter a new wave.”
— Dr. Riccardo Panicucci, a top scientific advisor to NRx
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