JMP Securities Downgrades Dynavax Technologies (DVAX) to Market Perform

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Go back to JMP Securities Downgrades Dynavax Technologies (DVAX) to Market Perform

StreetInsider.com Pre-Open Movers 6/10: (STEL) (CSIQ) (SUPN) Higher; (DVAX) (ROVI) (EAC) Lower (more...)

June 10, 2013 9:31 AM EDT

Dynavax Technologies Corporation (NASDAQ: DVAX) 29.1% LOWER; reported that it recently concluded a meeting with FDA regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult hepatitis B vaccine. The meeting followed recommendations expressed in November 2012 by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the size of Dynavax's safety database. The meeting with FDA resulted in the following messages: * The safety database does indeed need additional subjects; * VRBPAC's strong endorsement of HEPLISAV's demonstrated immunogenicity was acknowledged; * Analyzing the benefit/risk of HEPLISAV's use in discrete patient populations did... More

FDA Requests More Info from Dynavax (DVAX) for HEPLISAV BLA

June 10, 2013 6:24 AM EDT

Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it recently concluded a meeting with the U.S. Food and Drug Administration (FDA or Agency) regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult hepatitis B vaccine. The meeting followed recommendations expressed in November 2012 by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the size of Dynavax's... More