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.

28th Oct 19

FDA Provides Guidance on Bronchitol Approval Steps - FDA Expected to Complete Review Q2 2020

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Group (Chiesi) has received detailed advice from the US Food and Drug Administration (FDA) on its plan to fulfil the requirements necessary to approve Bronchitol® (mannitol) for the treatment of adult cystic fibrosis patients in the United States. Based on this feedback Chiesi has added an additional month to its timetable. The FDA review of the Bronchitol NDA is therefore now expected to be completed in the second quarter of 2020.

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24th Oct 19

Pharmaxis Cancer Drug Progressing in Clinic

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced that following positive clinical Phase 1A study results, it has begun dosing healthy subjects in the second stage of its study of an oral anti-fibrotic Lysyl Oxidase (LOX) inhibitor. This drug is being targeted to treat cancers including myelofibrosis and pancreatic cancer.

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17th Oct 19

Pharmaxis Receives $6.2m R&D Tax Incentive as it Advances Drug Candidates into Clinical Development

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) has received a $6.2 million R&D tax incentive in relation to the 2019 financial year. The receipt of this incentive adds to the Company’s cash funds, which were $31 million at 30 June 2019.

The 2019 incentive effectively reduces Pharmaxis 2019 expenditure on research and development by more than 40%.

Pharmaxis CEO Gary Phillips said, “The R&D tax incentive provides significant leverage to the Pharmaxis research team’s development of new drugs for inflammation and fibrotic diseases. The Pharmaxis research team has taken four in-house compounds to Phase 1 trials in just five years and in the 2019 year alone completed phase 1 trials in two LOXL2 inhibitors, commenced phase 1 trials in a systemic LOX inhibitor compound and advanced a topical LOX inhibitor through preclinical development.”

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