Biotech Values

[genisi]

DX-88 could be approved by year end for acute HAE:

Dyax says FDA accepts genetic-disease drug response

http://www.reuters.com/article/marketsNews/idINBNG25559220090608?rpc=44

* FDA sets Dec 1 as new target action date

* Shares up 16 pct in pre-market trade

June 8 (Reuters) - Biotechnology company Dyax Corp (DYAX.O: Quote, Profile, Research, Stock Buzz) said U.S. health regulators accepted the complete response submission for its experimental treatment for a rare genetic disease, sending its shares up 16 percent.

The company said the U.S. Food and Drug Administration (FDA) has set Dec. 1 as a target action date to complete the review of the drug.

The drug, ecallantide, is for the treatment of acute attacks of hereditary angioedema (HAE), a potentially life-threatening genetic disease characterized by painful swelling of the skin, intestine, mouth and throat.

In March, the FDA declined to approve the drug in the present form and sought additional data on the safe use of the drug. [ID:nBNG366348]

"We are confident that our proposed risk evaluation and mitigation strategy for assuring the safe use of DX-88 and our response to other FDA requests thoroughly address the matters raised in the agency's letter," said Chief Executive Gustav Christensen

Shares of the company were up 20 cents at $2.07 in pre-market trade. They closed at $1.87 Friday on Nasdaq.