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

4 August 2017
2019_biotech_test_vial_discovery_big

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology