Dynavax says FDA rejects its hepatitis B vaccine

[November 14, 2016]  (Reuters) - Dynavax Technologies Corp said on Monday the U.S. Food and Drug Administration had rejected the marketing application for its hepatitis B vaccine Heplisav-B, sending the company's shares tumbling 65 percent in premarket trading.

The drug developer said it received a "complete response letter" from the FDA, seeking information about certain "adverse events" during clinical trials, among other clarifications.

Dynavax said there was no request from the FDA for additional clinical trials and there were no apparent concerns about rare serious events.

Dynavax Chief Executive Eddie Gray said the company would meet with the FDA "as soon as possible" to discuss the letter.

"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," Gray said.

Dynavax had $109.6 million in cash, cash equivalents and marketable securities as of Sept. 30.

The FDA acknowledged in its letter that it had not yet completed its review of responses to clarifications received from the company early last month, Dynavax said.

The company said it expects the review period for a possible resubmission of its application would be six months.

Up to Friday's close of $11.60, Dynavax's shares had dropped about 52 percent this year.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Sai Sachin Ravikumar)

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