ContraVir Pharmaceuticals Inc CTRV shares have been highly volatile of late, with the promise offered by its non-alcoholic steatohepatitis drug cushioning any downside for the stock.
The shares were making a strong upward move Friday from the all-time low reached in the previous trading session.
ContraVir, a thinly traded nanocap biotech, said Thursday after the close the FDA has given it positive feedback in response to its pre-IND meeting about its NASH pipeline asset CRV431.
The positive feedback pertained to preclinical data for CRV431, with the regulatory body agreeing with ContraVir's proposed plan for further preclinical studies to support the development of the asset. The FDA also supported the study design for the NASH IND opening study, the company said.
"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," ContraVir CEO Robert Foster said in a statement.
In addition to NASH, the company also has an existing IND for CRV431 in the treatment of hepatitis B virus, or HBV.
An Eventful June
ContraVir effected a 1-for-70 reverse stock split in early June.
Later, on June 6, the company reported preclinical data for CRV431 that showed a significant reduction in the extent of fibrosis in a second animal model of liver fibrosis, which led to a roughly 42% jump in the stock.
The stock also received support from a company release on the publication of a research article on CRV431's effectiveness in treating HBV in animal models. This sent the stock soaring about 36% on June 11.
Most recently, ContaVir pulled back by about 44% to $5.30 on June 18 on the news of a common stock offering.
The positive regulatory feedback on CRV431 has once again lent support to the stock.
ContraVir shares were rallying by 28.37% to $5.55 at the time of publication Friday.
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