Dynavax's Stock Plunges After Disappointing FDA Response To Hep-B Treatment

Shares of Dynavax Technologies Corp. plunged 71% toward an eight-year low in premarket trade Monday, after the Food and Drug Administration didn't approve its Hepatitis B treatment. The company said it received a complete response letter (CRL), which means the FDA completed its review but is requesting additional information, regarding its biologics license application (BLA) for Heplisav-B for adults. The "several" topics that CRL requests information on includes clarification regarding specific adverse events of special interest, a numerical imbalance in some cardiac events and analysis of the integrated safety data base across different time periods. "The CRL is consistent with our opinion that HEPLISAV-B is approvable and we are seeking to meet with the FDA as soon as possible," said Chief Executive Eddie Gray. "However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner." The stock has tumbled 52% year to date through Friday, while the S&P 500 has gained 5.9%.