Shares of Relief Therapeutics Holding SA (OTCMKTS:RLFTF) fell 13% after the biopharmaceutical company said the parent company of its US partner NRx Pharmaceuticals has submitted a revised Investigational New drug module. The submission to the US Food and Drug Administration is for the manufacturing of ZYESAMI(TM) (aviptadil).
The module is to be used as part of the FDA’s review process supporting the ZYESAMI(TM) New Drug application. The documentation indicates that Nephron Pharmaceuticals is ready to supply ZYESAMI(TM) for commercial scale.Additionally, Relief Therapeutics partner NRx has received a notification indicating the European Qualified Partner Auditor has completed an inspection at a separate manufacturing facility. NRx now awaits the QP declaration that is required by EU authorities for the release of ZYESAMI(TM).
The audit also paves the way for ZYESAMI(TM) submission to the European Union Standard and United Kingdom Health regulatory authorities.”As thousands of people around the world continue to die each day from COVID-19, we are continuing our efforts to ensure that NRx has the supply and logistics in place to provide ZYESAMI to patients where it is granted regulatory approval,” said Prof Jonathan Javitt, MD, MPH, CEO, and Chairman of NRx.
Market Reaction:
On Wednesday, RLFTF stock decreased 13.31% at $0.1101 with more than 5.66 million shares, compared to its average volume of 5.17 million shares. The stock has moved within a range of $0.1015 – 0.1174 after opening the trade at $0.1173.
