Type: Investor Centre
Description: Pharmaxis (ASX:PXS) announced the United States Food and Drug Administration (FDA) has approved Bronchitol® (mannitol) as add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients 18 years of age and older. The product, developed by Pharmaxis in Australia, has been steered through final stages of FDA approval by US licensee Chiesi Farmaceutici SpA (Chiesi).
Pharmaxis also 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.
PrimaryMarkets now operates an Investor Centre for Pharmaxis, a dedicated online Platform to support investor awareness and market eduction.
Read full releases:
- FDA Approves Bronchitol for US Market - ASX Announcement
- Pharamaxis Prioritises Breakthrough Clinical Program on Myelofibrosis
- FDA Bronchitol Approval to Generate Cash Flows for Pharmaxis
Pallas has an impeccable track record providing in excess of A$415m total investments since inception across 73 debt and equity transactions (55 debt) and a range of real estate sectors, currently totalling in excess of A$260million in single asset and diversified trusts Funds Under Management (FUM) as at 30 September 2020. Of those 73 transactions, 39 are first mortgages that have delivered an average net return of 9.4% pa.
Pallas Capital is raising up to A$100m; initial issue c.A$30m. A fixed coupon of 7.5% p.a. is payable over a 4 year term in denominations of A$10,000.
In additional to the current research and development for genomic applications in Cognitive Impairment and Oncology, GMDx has now partnered with Oracle to provide Genomic Data Services to the wider market. This undertaking will provide GMDx customers and collaborators with access to a new generation of genomic analytics to enhance research and development capabilities, drug discovery and development and clinical trials.
Description: GMDx is a genomics testing company that delivers the next generation of immunogenomic diagnostics in oncology. GMDx was established in 2015 to further develop and commercialise the discoveries of Dr Robyn Lindley. GMDx has developed a comprehensive and powerful genomic-profile testing platform with the clinical applications in oncology for:
- predicting patient response to immunotherapy treatment and
- predicting cancer progression.
The GMDx platform technology combines proprietary predictive algorithms, a strong and extensive IP portfolio, sophisticated analytics and machine learning capabilities that provide customers with clinical grade whole genome testing.