Pharmaxis stock soars on fast track approval

Shares of drug developer Pharmaxis soared 20% after the company said it was granted fast track status by the Food and Drug Administration for its cystic fibrosis drug Bronchitol. The designation, which is granted for experimental drugs intended to address unmet medical needs, allows an expedited FDA review of its marketing application through a rolling submission, instead of submission of the entire application at once. The drug has already been granted orphan drug status for rare diseases, which waives the company's application fee and allows for certain tax benefits and marketing exclusivity.
Shares of Pharmaxis recently changed hands at $42, up $7.


What exactly is bronchitol and how does it work to be granted fast track?

Cystic fibrosis is the abnormal production and ineffective clearance of mucus in the lungs. Bronchitol restores the ability of patients’ lungs to clear mucus by promoting salt and water movement through airway cells.
Bronchitol is produced form a naturally occurring sugar called mannitol. The mannitol is formulated into a dry powder with a particle size small enough to allow it to be inhaled the lungs.
Bronchitol is thought to increase mucus clearance by changing the viscosity of the mucus and by acting like salt in the lung to draw water out of airway cells. It also stimulates the cough reflex to clear the excess mucus. If this works, it could really help the lives of people suffering from CF.

PXSL soared today with the NASDAQ composite about to close, is up 6 dollars (17%) to $41.22.