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.

14th Jul 20

FDA Grants Orphan Drug Status for Pharmaxis Anti Fibrotic Drug for Myelofibrosis

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced that the U.S. Food & Drug Administration (FDA) has granted orphan-drug designation for its oral pan LOX inhibitor PXS-5505 for the treatment of myelofibrosis.

Read full media release - pdf
2nd Jun 20

Pharmaxis to Present at Monsoon Communications Webinar

Pharmaxis Ltd (ASX: PXS) chief executive officer Mr Gary Phillips will present at the Monsoon Communications Webinar on Wednesday 3 June 2020 at 11:00am AEST.  The webinar will be hosted by David Blake, publisher of Bioshares and will feature presentations by Mr Phillips and Opthea CEO & Managing Director Dr Megan Baldwin.

Shareholders and investors are invited to participate in this free event.

The event is free and investors should register in advance to participate using the following registration link:  

https://us02web.zoom.us/webinar/register/WN_1WHGL760Tsa2nxWO98c3KQ?mc_cid=cb47f079b0&mc_eid=5820d91b14

13th May 20

FDA Acknowledges Receipt of Bronchitol NDA Resubmission - Decision Review Date 1 November 2020

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Farmaceutici S.p.A. (Chiesi) has received acknowledgement of receipt of the Bronchitol NDA resubmission from the US Food and Drug Administration (FDA). The receipt of this communication from the FDA indicates that the submission responds to all issues raised in the complete response letter received in June 2019.

However, the FDA have classified the resubmission as Class 2 which changes the FDA review period from an expected two months to six months and sets a    Goal Action Date of 1 November 2020.

Read full media release - pdf