CTRV stock is one of the biggest biotech stocks after ContraVir Pharmaceuticals Inc (NASDAQ:CTRV) gets a positive response from the FDA to its pre-IND meeting for developing CRV431 in NASH.
New Jersey-based biopharmaceutical company ContraVir Pharmaceuticals, which is involved in manufacturing medicines meant for treating liver diseases originating from non-alcoholic steatohepatitis (“NASH”) and chronic viral infection, made a major announcement today. The company got a highly positive update from the United States Food and Drug Administration with regards to the company’s pre-Investigational New Drug meeting related to the product CRV 431. After having studied the pre-clinical data with regards to the product, the FDA provided positive feedback and has supported the commencement of opening study.
Additionally, the FDA has gone on to agree with the company’s proposal that there should be more pre-clinical studies regarding the drug. These are highly important developments and have provided ContraVir with a major boost.
CTRV stock rose by as much as 40% to $5.99.
Dr. Robert Foster, who is the Chief Executive Officer of ContraVir, stated, “We are pleased with the FDA’s positive feedback on the preclinical work we’ve completed to date, as well their feedback on additional planned studies that will support an IND submission for CRV431 in NASH. This IND submission for NASH will be in addition to our current existing IND for hepatitis B virus treatment. We have generated compelling and consistent anti-fibrotic data from five separate studies in two different animal models and believe CRV431 holds great promise for this indication.”
It remains to be seen how the company goes about working on this product in the coming months following the boost that it has received from the FDA. Although it is true that confidence demonstrated by the FDA is going to be a huge factor, the company still needs to go through several stages before it can bring the finished product into the market. That being said, the current optimism is not misplaced.
However, CTRV stock is still down 75% so far in 2019 and 95% from its 52-week high of $117.60.
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