FDA’s Positive Feedback for this Biotech Sends Shares Soaring 30%


A biotech firm developing a new drug for liver disease treatment got a shot in the arm today as the FDA came out with positive feedback for its pre-Investigational New Drug (IND) meeting around a product currently known as CRV431.

A press release today shows that ContraVir Pharmaceuticals (NASDAQ: CTRV) received the feedback today from the US regulator where the FDA indicated it supports the study design for the drug’s opening study.

“The FDA also concurred with the company’s proposed plan for further pre-clinical studies to support the development of CRV431,” press release writers revealed.

Indications are that the FDA generally supports the company’s clinical development plans for the drug, which is intended to treat nonalcoholics steatohepatitis or ‘NASH’.

“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,” responded Dr. Robert Foster, Chief Executive Officer of ContraVir in a press statement. “This IND submission for NASH will be in addition to our current existing IND for hepatitis B virus treatment,” … Liver fibrosis is a very harmful feature of NASH, and the anti-fibrotic mechanism of CRV431 differentiates it from most drugs in development for NASH. We intend to continue our thorough examination of additional models, both in vitro and in vivo, to support our push to phase 2 clinical trials.”

Fibrin research is helping sufferers from various health conditions including fibromyalgia and internal scarring to reduce symptoms and improve quality of life.

In pre-market activity, CTRV stock surged some 30% to crest above the $5 mark. That’s a new indicator for an equity that has been falling as of late. The breaking FDA news may be what CTRV needs to turn positive.