UPDATE: Dynavax (DVAX) Drops; FDA Cancels Adcom to Resolve Issues
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Dynavax (DVAX) VRBPAC Cancellation Implications are More Positive than Negative - Cowen
September 6, 2016 9:08 AM EDTCowen analyst Phil Nadeau reiterated an Outperform rating and $45 price target on Dynavax Technologies (NASDAQ: DVAX), saying the implications from November's VRBPAC meeting cancellation is more positive than negative. Dynavax's closed down 32% on Friday as investors viewed it as negative.
Nadeau commented, "Over the weekend DVAX issued a press release about the... More
Dynavax (DVAX) Announces Regulatory Update for HEPLISAV-B
September 6, 2016 6:33 AM EDTDynavax Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)].
During recent conversations between Dynavax and the FDA, the Agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15, 2016. The Agency informed... More
