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.

5th May 20

Chiesi Files Resubmission to Address FDA Bronchitol (Mannitol) Inhalation Powder Complete Response Letter

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group) has filed a resubmission that addresses the issues raised by the US Food and Drug Administration (FDA) in a complete response letter received in June 2019 to the Bronchitol® New Drug Application (NDA).  This resubmission follows Chiesi Group’s successful completion of a supplemental human factor study in Q1 2020 which was the most significant body of additional data required by the FDA. The proposed indication for Bronchitol is management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies. The FDA review of the Bronchitol NDA is expected to be completed in mid-2020.

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4th May 20

Pharmaxis Appoints Dr Neil Graham as Director

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) is pleased to announce the appointment of experienced senior global pharma and biotech executive Dr Neil Graham to the Board as a non-executive director.

Dr Graham is a medicines development expert and infectious diseases epidemiologist who has had a distinguished academic and business career. He recently retired as Vice President of Strategic Program Direction at Regeneron (REGN:US) where he was responsible for the pipeline portfolio and successfully leading development of immunology and inflammation products from preclinical development to post-launch.

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30th Apr 20

Pharmaxis CEO to Present at Virtual Health Conference

Pharmaxis Ltd (ASX: PXS) chief executive officer Mr Gary Phillips will present at the NWR Virtual Health Conference to be held on Friday 1 May & Monday 4 May, 2020.  Mr Phillips will provide details of recent progress in the Pharmaxis drug discovery pipeline and additional commentary on the information included in the latest Pharmaxis Quarterly Shareholder Update released earlier today, available of the company website.

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

Event: NWR Communications Virtual Health Conference

Presenting: Gary Phillips, CEO

Time/date: 1:40pm AEST, Friday 1 May

The event is free and investors should register in advance to view the presentation at: https://t.co/sY5jB3KKEi?amp=1

Read full media release - pdf