Pharmaxis submits Investigational New Drug application for treatment of myelofibrosis
The application to the US Food and Drug Administration (FDA) is for a planned phase 1/2 study of PXS-5505 which is expected to start later this year.
Company
Syntara Ltd
ASX:PXS
Syntara Ltd is a clinical-stage drug development company focused on the development of novel therapeutics aimed at correcting extracellular matrix (ECM) dysfunction. This will lead to positive outcomes in a range of diseases with high unmet need, including haematological malignancies such as myelofibrosis and myelodysplastic syndrome, chronic fibrosis (including skin scarring, pulmonary fibrosis, chronic kidney disease, NASH and cardiac fibrosis) and neuroinflammation.
175 stories · page 4 of 9
Pharmaxis granted orphan drug designation for PXS‐5505 by FDA for treatment of myelofibrosis
Orphan designation qualifies the sponsor of the drug for various development incentives such as reduced regulatory fees and extended periods of market exclusivity.
Pharmaxis US licensee Chiesi files resubmission for Bronchitol with FDA, sets clock ticking for potential launch and US$10 million cash milestone
Resubmission follows Chiesi Group’s successful completion of a supplemental human factor study which was the most significant body of additional data required by the FDA.
Pharmaxis US licensee Chiesi files resubmission for Bronchitol with FDA
Resubmission follows Chiesi Group’s successful completion of a supplemental human factor study which was the most significant body of additional data required by the FDA.
Pharmaxis strengthens board through appointment of Dr Neil Graham
The new US-based non-executive director is an experienced senior global pharma and biotech executive.
Pharmaxis eyes partner funding for LOXL2 inhibitor program; CEO to present at virtual health conference
The company completed both its phase 1b trial of its systemic pan‐LOX inhibitor and a further phase 1 dosing study of its LOXL2 inhibitor in March.
Pharmaxis cancer drug ready to start myelofibrosis phase 2 studies this year
A pre-clinical program, regulatory advice and opinion from leading clinicians supports progression into phase 2 study of the rare bone cancer with high unmet need and significant market opportunity.
Pharmaxis advancing anti fibrotic compounds towards phase 2 clinical trials; Bronchitol sales rise with FDA decision expected mid-year
The company is adding to the LOXL2 data package with a small but important phase 1 study investigating the effect of food and different dosing regimens.
Pharmaxis resourced to complete partnering and clinical development milestones
Boehringer Ingelheim diabetic eye study continues after discontinuation of NASH trial.
Pharmaxis anti-fibrotic pipeline review highlights drug with strong pre-clinical data for bone marrow cancer myelofibrosis
The company’s CEO Gary Phillips has presented during the 2019 AusBiotech Conference in Melbourne.
Pharmaxis licensee receives US FDA guidance on Bronchitol approval steps
The FDA review of the Bronchitol NDA (new drug application) is expected to be completed in the second quarter of 2020.
Pharmaxis begins dosing patients in phase Ib study
This drug is targeting the treatment of cancers including myelofibrosis and pancreatic cancer.
Pharmaxis cash funds for development of new drugs boosted by $6.2 million R&D tax incentive
Receipt of this incentive adds to the company’s cash funds, which were $31 million at 30 June 2019.
Pharmaxis features in APAC’s top 100 most innovative pharma companies report
Pharmaxis was ranked 38 out of the 100 companies named as innovators in the small to medium- sized enterprises category.
Pharmaxis continues to add value to portfolio assets; Bronchitol reaches pivotal stage
The company is confident that the FDA will have the information it requires to be able to approve Bronchitol by Q1 2020.
Pharmaxis on track to complete FDA approval process for Bronchitol in Q1 2020
If Bronchitol is approved by the US FDA, Pharmaxis will receive US$10 million.
Pharmaxis welcomes US FDA committee’s recommendation on use of Bronchitol in CF
If Bronchitol is approved later this year, Pharmaxis is down to receive US$10 million.
Pharmaxis prepares for advisory committee meeting on use of Bronchitol in the US
The US Food and Drug Administration has convened a meeting of the Pulmonary-Allergy Drugs Advisory Committee on May 8, 2019.
Pharmaxis gains new substantial holder with 6.89% interest
The company is developing a pipeline of products to treat inflammation and fibrosis.
Pharmaxis sees progress in Boehringer Ingelheim’s clinical trial in patients with NASH
Boehringer Ingelheim has completed enrolment of the Phase 2a clinical trial of a Pharmaxis developed drug in NASH.