Revive Therapeutics is Finalizing an FDA Application, Stock Reacts Positively
One of the life sciences companies to have made a major move on Tuesday was that of Revive Therapeutics Ltd (OTCMKTS:RVVTF) after the company made a major announcement this month.
Finalizing An FDA Application To Start Phase 3 Clinical Trial To Evaluate Bucillamine
The company is involved in the development of medicines meant for rare disorders and for infectious diseases. It should be noted that the company also boasts of a CBD product portfolio. Earlier this month, it emerged that Revive is looking to repurpose its gout medicine Bucillamine to tackle the novel COVID 19 virus. The company also revealed that it was on the verge of finalizing its application to the United States Food and Drug Administration for the Phase 3 clinical trial that is going to evaluate Bucillamine for lung inflammation.
The stock soared by as much as 20% on Tuesday as more and more investors piled on to it in anticipation of a potentially positive outcome. It remains to be seen if the Revive stock can manage to add to its gains over the course of the week or not. However, it is necessary for investors to know a bit more about medicine Bucillamine.
While it is being put forward as a possible treatment for coronavirus patients, it needs to be kept in mind that it has a highly impressive clinical history with regards to the treatment of Rheumatoid Arthritis. If the approval is granted by the FDA, then the study is going to commence at some point in the third fiscal quarter of the year. The submission of the investigational new drug application is however only the first steam. That being said, it is easy to see why investors are excited about the developments.
The company is planning to conduct the trial with as many as 800 subjects and hence, it could be argued that Revive has planned an extensive study. In that study in question, the patients are going to be administered with Bucillamine in addition to standard of care treatment.
The company is going to publish an interim analysis from the study after 210 patients have been administered with the medicine and been observed for a stretch of 28 days. It is important to reiterate though that Bucillamine is a pretty well-known product and has been marketed in countries like South Korea and Japan for more than three decades.
This submission has been in the works for quite some time and news had first emerged regarding this back in June. Considering the fact that coronavirus cases are piling up yet again, the need for more and more treatments for the same is greater than ever. Investors could do well to keep an eye on the Revive stock and the developments around the company in the coming months.
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