Protalix Biotherapeutics Inc. (AMEX:PLX) and its shareholders face a fateful week. By Thursday, the US Food and Drug Administration (FDA) is schedule to decide whether the company can sell its treatment for Gaucher's disease in the US, or if it wants further clarifications before authorizing the drug.
The FDA is reviewing Protalix New Drug Application (NDA) taliglucerase alfa for the treatment of Gaucher disease. The FDA has already granted the drug orphan drug status and fast track designation, and Protalix provides the drug to Gaucher patients in the US under an Expanded Access protocol, as well as to patients in Europe, Israel, and other countries under named patient provisions.
Approval of the Gaucher's treatment will be an important milestone for Protalix, as its innovative drug targets a $1 billion a year market.
Halman Aldubi Investment House CEO Dan Aldubi says that Protalix is more likely to get a positive answer from the FDA than a negative one. Aldubi pointed out that Protalix has a very high short interest, in fact, one of the highest on the stock exchange, at 8.5%. "This increases the likelihood of a short squeeze, massive purchases by holders of short positions ahead of the FDA announcement," he said.
Protalix's share closed at $7.67 on the American Stock Exchange (AMEX) on Friday, giving a market cap of $522 million.
Published by Globes [online], Israel business news - www.globes-online.com - on June 20, 2010
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