UPDATE 4-Dynavax shares soar as hepatitis B trials resume

Thu Sep 10, 2009 10:41pm BST
[-] Text [+]

* FDA lifts clinical hold on Dynavax hepatitis B vaccine

* Could have product on the market by end of 2012

* Shares jump 45.7 percent (Updates with analyst comment, closing share price)

By Toni Clarke

BOSTON, Sept 10 (Reuters) - Dynavax Technologies Corp (DVAX.O: Quote, Profile, Research) said on Thursday that U.S. regulators have given it the green light to move forward with its experimental hepatitis B vaccine, sending the company's shares up nearly 46 percent.

The U.S. Food and Drug Administration placed the product on clinical hold 18 months ago due to safety concerns. Dynavax presented additional data to the agency, which has now given it the go-ahead to immunize patients with chronic kidney disease who do not respond well to an existing product.

The news surprised investors, who had largely written off the vaccine, Heplisav. Last November the company's shares fell to 15 cents, down from more than $10.00 in late 2006. They closed up 80 cents at $2.55 on Wednesday, having trading as high as $3.35 earlier in the day.

Hepatitis B is a chronic disease which can lead to cirrhosis of the liver. There is no cure for the condition. The only vaccine on the market is Engerix-B, made by GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research). Dynavax believes Heplisav is more effective and can be given in fewer doses than Engerix-B.

The FDA put Heplisav on hold last March after one patient developed a case of Wegener's granulomatosis, an inflammatory autoimmune disease that affects the small blood vessels and can cause extensive tissue damage.  Continued...

 
DVAX.O
Last:
Change:
Up/Down:
 
by Name by Symbol