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.
Pharmaxis Announces LOXL2 Inhibitor Program is Phase 2 Ready Following Completion of 13 Week Toxicity Studies
Pharmaceutical research company Pharmaxis (ASX: PXS) today announced that it has now received reports on all of the 13-week toxicity studies conducted for each of its two Lysyl Oxidase Like 2 (LOXL2) inhibitors. Together with the previously released results of Pharmaxis phase 1 clinical trials for both compounds showing best in class target engagement from a once a day oral dose, Pharmaxis believes that this program is now ready to enter phase 2 clinical studies for fibrotic diseases such as Non‐Alcoholic Steatohepatitis (NASH), cardiac fibrosis and Idiopathic Pulmonary Fibrosis (IPF).Read full media release - pdf
Pharmaceutical research company Pharmaxis (ASX: PXS) today announced the resubmission of the Bronchitol New Drug Application with the United States Food and Drug Administration (FDA) by its licensee Chiesi Group (Chiesi).
The resubmission responds to the matters raised by the FDA in its Complete Response Letter issued in March 2013 and includes the results of the phase 3 clinical trial conducted after consultation with the FDA. The trial reported in June 2017.
Pharmaxis expects the FDA review process to take between six and twelve months to conclude. Chiesi is responsible for the regulatory approval and commercialisation of Bronchitol in the United States. If Bronchitol is approved by the FDA, Pharmaxis will receive a US$10 million milestone payment on the commercial launch of Bronchitol in the US and, mid to high teen percentage royalties on in-market net sales, and Pharmaxis will be the exclusive supplier of Bronchitol for the US market.Read full media release - pdf