Dynavax Technologies Corporation (DVAX) stock has been on a rollercoaster ride all week. The company’s stock skyrocketed on Monday, rising nearly 25% from Friday’s close. The company’s stock has since plummeted over 16%, with the stock losing 12.9% on Tuesday alone.
The reasons for the company’s stock rising and falling so fast are:
1. Dynavex’s Form 8-K Disclosure
The company’s Form 8-K disclosed that the company received requests for information for its HEPLISAV-B drug. The company’s stock skyrocketed on the news. The company has been working towards a December 15, 2016 review completion date.
An approved review would lead to a stock price rise and would help the company’s bottom line.
2. Fears of the Hepatitis B Vaccine Being Rejected Rise
Dynavax’s hepatitis B vaccine is on pace for its review deadline, but there are concerns that the FDA will reject the vaccine in December, which resulted in the company’s stock tumbling on Tuesday.
Issues arose as the FDA delayed their decision on the drug earlier in the year, pushing back the review from November to December.
3. FDA Cancelled a Key Advisory Committee Meeting
The FDA cancelled a key advisory committee meeting to discuss the vaccine when the review date was pushed back. The FDA stated that they needed more time. The track record of approvals following a cancelled advisory committee meeting are in favor of a rejection.
Over 85% of cancelled meetings result in a rejection.
A rejection would be bad for the company going forward. The company’s vaccine is stated to be more effective than the competition and will need to be administered just twice over a month’s time to be effective.
The leading hepatitis B vaccine requires three dosages over a six-month period.
The vaccine was rejected in 2013 over fears related to autoimmune disease. Dynavax has since completed studies on the matter.