Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) is a clinical-stage biopharma corporation that recently announced that the FDA (Food and Drug Administration) had given them an official written response from the pre-IND (Investigational New Drug) Type B meeting to develop its TNX-1800 product (live vaccine, recombinant horsepox) as a potential COVID-19 vaccine.
Tonix Pharmaceuticals believes the response will provide the company with a path to several other agreements on the overall design of a 1st Phase study as well as the clinical development plan viable enough to qualify its TNX-1800 drug product as a COVID-19 vaccine. According to the response, Tonix expects to start the Phase I trials at the beginning of next year.
The TNX-1800 product is a live virus with a horsepox viral sector base designed to battle the SARS-CoV-2 protein and protect the body from the COVID-19. It primarily does this by eliciting T Cell responses. Tonix pharmaceuticals also reported positive efficacy information from the animal trial is conducted at the beginning of this year.
Market Reaction:
On Wednesday, TNXP stock gained 1% at $0.6206 with more than 7.65 million shares, compared to its average volume of 11.48 million shares. The stock has moved within a range of $0.6080 – 0.6297 after opening the trade at $0.62.
