News

For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.

2nd Nov 20
2nd Nov 20

Pharmaxis Prioritises Breakthrough Clinical Program on Myelofibrosis

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced details of the clinical development plan for its lead drug pipeline asset being studied for the bone marrow cancer myelofibrosis.

PXS-5505 has already received IND approval and Orphan Drug Designation from the FDA and will proceed to an open label study recruiting up to 42 patients with myelofibrosis in Australia and international sites. PXS-5505 is a pan-LOX inhibitor that seeks to reverse the bone marrow fibrosis that drives morbidity and mortality in the disease.  

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2nd Nov 20

FDA Approves Bronchitol for US Market

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced the United States Food and Drug Administration (FDA) has approved Bronchitol® (mannitol) as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis (CF). The product, developed by Pharmaxis in Australia, has been steered through final stages of FDA approval by US licensee Chiesi Farmaceutici SpA (Chiesi).

A US$7 million milestone is now payable to Pharmaxis by Chiesi with a further US$3 million payable on shipment by Pharmaxis of commercial launch stock scheduled for the first quarter of 2021.

Pharmaxis expects Bronchitol sales in the US market to contribute strongly to the product’s global sales and profit growth from its launch in Q2 2021, making the mannitol business (Bronchitol® and Aridol®) cash flow positive from FY 2021.

Read full media release - pdf