Pharmaxis Limited (ASX: PXS) is in pre-open this morning after the ASX granted a trading halt after the company received the Complete Response Letter from the U.S. Food and Drug Administration (FDA).
The letter is in relation to the New Drug Application for Bronchitol® for the treatment of cystic fibrosis.
Pharmaxis is a pharmaceutical company involved in the research, development and
commercialisation of therapeutic products for chronic respiratory disorders.
Its product Bronchitol® recently launched in Europe and Australia and its development pipeline of products includes, Bronchitol for bronchiectasis, PXS64 for the treatment of lung fibrosis, ASM8 for asthma and PXS4728 for fibrotic disease.
The halt will last until the earlier of an announcement being made to the market, or the opening of trade on Thursday 21st March 2013.
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