Despite positive recent advisory view, FDA calls for more info on Heplisav-B

4 August 2017

Just as things were looking up for Dynavax Technologies (Nasdaq: DVAX) and its hepatitis B drug candidate, US regulators have thrown a spanner in the works, causing the firm’s share to plunge 9.74% to $15.34 in after-hours trading on Thursday.

Dynavax yesterday revealed that the FDA has requested more detailed information about the company's proposed post-marketing study for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]) based on feedback received from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) during a meeting on July 28, 2017.

An FDA decision about the vaccine's approval is now expected by November 10. Dynavax said it plans to respond "expeditiously" to the FDA's request and that it still plans to launch the vaccine in the USA in early 2018.

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