NRX Pharmaceuticals Inc. (NRXP) stock prices were up by 61.06% as of the market closing on October 12th, 2021. This brought the price per share up to USD$10.92 at the end of the trading day. Subsequent premarket fluctuations have seen the stock dip by 8.42%, bringing it down to USD$10.00.
NRXP Stock Works with FDA
October 12th, 2021 saw NRXP stock announce the submission of a revised IND module on the manufacturing of ZYESAMI was submitted to the U.S FDA. The revised Investigational New Drug module included documentation that confirmed Nephron Pharma’s being prepared to supply the ZYESAMI treatment on a commercial scale. The module will be used by the United States Food and Drug Administration’s rolling review process in support of the New Drug Application for ZYESAMI.
Procedure for Commercial Development
The company continues to allocate resources towards ensuring adequate supply and logistics to curb the ongoing global pandemic, which continues to claim thousands of lives globally every day. The company is keen to push for the accelerated provision of ZYESAMI to patients in regions where the treatment has been granted regulatory approval. To this end, NRXP stock has been notified that a European QP (Qualified Perons) Auditor has concluded an inspection at a separate manufacturing facility with no adverse findings. The company is waiting for a QP Declaration, which is required by the regulatory authorities in the EU in order for ZYESAMI to be released. The audit was concluded in preparation for submission of EU-standard ZYESAMI to EY and UK health regulatory authorities. As per EU law, a QP auditor is charged with certifying that each batch of a medicinal product meets all required provisions following its release from a manufacturing facility within the EU or importing into the EU.
About ZYESAMI
NRXP stock’s ZYESAMI is a synthetic form of Vasoactive Intestinal Polypeptide (VIP), which was initially discovered in 1970. It was first purified from the intestinal tract, despite being primarily concentrated in the lung. VIP binds specifically to the alveolar type 2 cell (AT2) in the air sac (alveolus) of the lung. It has been shown to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation.
Future Outlook for NRXP Stock
NRXP stock reported a strong quarter, consolidated by the promising development made in regard to the development of its proprietary ZYESAMI treatment. The company is keen to push for the accelerated commercialization and proliferation of its flagship treatment, which it hopes will help with global Covid-19 efforts. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value.
