A wholly owned subsidiary of Intrexon Corporation (NYSE:XON) [Trend Analysis] committed to enabling the study of life-threatening human diseases, Exemplar Genetics released that U.S. Food & Drug Administration (FDA) has exercised enforcement discretion in regard to the ExeGen low-density lipoprotein receptor (LDLR) miniswine clearing it for commercial use as a research model.
As the first genetically engineered (GE) miniswine model reviewed and cleared by the FDA, Exemplar’s powerful investigational platform can now be offered to researchers and drug developers helping forge a more reliable, consistent path from pre-clinical testing through human studies. The ExeGen LDLR model is a game-changer that enables superior translational research and better predictive efficacy in the generation of novel gene- and cell-based therapies, small molecules, as well as biologics for cardiac disease.
Intrexon Corporation (NYSE:XON) knocking active thrust in leading trading session, shares an advance of 1.19% to 27.24 with around 6.85 Million shares have changed hands in this session. The stock is going forward its fifty-two week low with 47.08% and lagging behind from its 52-week high price with -60.78%. Likewise the positive performance for the quarter recorded as 3.30% and for the year was -30.62%, while the YTD performance remained at -9.65%. XON has Average True Range for 14 days of 2.72.
Dynavax Technologies Corporation (NASDAQ:DVAX) [Trend Analysis] announced that U.S. FDA will require additional time to complete its review of the Biologics License Application (BLA) for HEPLISAV-B, Dynavax’s investigational vaccine for immunization of adults against hepatitis B infection. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) action date for HEPLISAV-B has been extended by three months to December 15, 2016.
On April 8, in response to an FDA request, Dynavax submitted individual trial data sets that had been provided as integrated data in the March 2016 BLA resubmission. FDA then determined that the addition of these large data sets represented a major amendment to the BLA and thus extended the PDUFA action date to allow for a full review.
Dynavax Technologies Corporation (NASDAQ:DVAX) retains strong position in active trade, as shares scoring -11.68% to $18.53 in an active trade session, while looking at the shares volume, around 3.58 Million shares have changed hands in this session. The firm has institutional ownership of 83.70%, while insider ownership included 0.36%. DVAX attains analyst recommendation of 1.80 with week’s performance of -15.89%. Investors looking further ahead will note that the Price to next year’s EPS is 54.90%.