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.
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Syntara advances multinational study targeting rare bone marrow cancer myelofibrosis
The clinical stage drug development company has boosted its balance sheet with a $4.4 million placement and the sale of Bronchitol Russian distribution rights for $2 million.
Pharmaxis receives interim data for Phase 2 cancer trial
The company is also raising $10 million in a two-tranche placement to a small group of international and domestic institutional investors.
Pharmaxis fields promising interim data from skin scarring treatment study assessing PXS-6302
“We will now work with UWA to design a follow up study that will address the need for objective endpoints to meet anticipated regulatory hurdles and explore further indications that suit the profile of PXS-6302," said CEO Gary Phillips.
Pharmaxis to tackle Parkinson’s in “groundbreaking” clinical collaboration
“This study provides hope for an effective treatment and a step towards the longer-term goal of stopping neurodegeneration,” said Pharmaxis CEO Gary Phillips.
Pharmaxis strikes a US$5 million deal with Aptar Pharma on Orbital drug delivery technology
Global drug delivery company Aptar Pharma has exercised its option for a worldwide licence on the Pharmaxis Orbital technology for US$2.5 million and a subsequent option for an outright purchase of the technology for a further US$2.5 millio
Pharmaxis appoints 20-year veteran as Chief Medical Officer
Pharmaxis has appointed Dr Jana Baskar to the role of Chief Medical Officer. Dr Baskar will bring strong oversight to the clinical stage drug development company.
Pharmaxis to host research and development showcase webinars for leading drug discoveries
Pharmaxis will host several presentations showcasing the company's leading drug discoveries and their applications. The webinars are free to access and recordings will be available on the Pharmaxis website.
Pharmaxis launches five new clinical trial sites in phase 2 bone marrow cancer trial
“This planned initiation of new trial sites in Taiwan will bring the total number of active sites to 16. The study is making pleasing progress as it builds to a recruitment target of 24 patients. This latest expansion of sites is part of a
Pharmaxis confident of capturing global market for scar reduction with first patients dosed in study
The collaboration with the research team led by Professor Fiona Wood AM has dosed the first patients in a trial of 50 patients with established scars.
Pharmaxis discoveries to get a A$1.4 million boost to advance cancer and skin disease treatments
“Together, our work aims to support commercialisation of new treatment approaches for pancreatic cancer and various skin diseases, which we hope will deliver significant benefits for patients,” PXS CEO Gary Phillips said.
Pharmaxis’ oversubscribed share purchase plan raises $2.6 million
The clinical-stage drug development company opted to increase its raise target from A$2 million after receiving eligible applications for A$2.585 million worth of shares.
Pharmaxis stocks rising with new drugs coming online in 2022, says broker
Among a range of factors for the outperform recommendation, Taylor Collison cites the company’s two FDA-approved respiratory products, Bronchitol for cystic fibrosis and the asthma diagnostic Aridol, which are expected to be profitable on a
Pharmaxis launches share purchase plan to raise approximately A$2 million to fund clinical trials and for working capital
The capital raise is part of its move to bolster its balance sheet as it enters a transformational 12 months with clinical trials of its lead drug PXS-5505 in cancer.
Pharmaxis bolsters balance sheet with $7.2 million placement and $2 million share purchase plan
“Pharmaxis is entering a transformational 12 months with two clinical studies expected to deliver safety and efficacy data in diseases with high unmet need and addressable markets of over $1 billion by the end of 2022," says CEO.
Pharmaxis receives FDA clearance to progress cancer drug to Phase 2 study in liver cancer
“The rapid progression from the compelling pre-clinical work presented for the first time in August to a successful IND submission is very encouraging and we look forward to concluding arrangements for the commencement of the dose escalatio
Pharmaxis attracts A$0.53 price target in coverage initiation from MST Access
“Pharmaxis is entering a potentially transformational period as it advances a portfolio of novel small molecule inhibitors of amine oxidases,” says analyst.
Pharmaxis embarks on phase two bone marrow cancer trial
Bone marrow cancer affects one in 100,000 people, but Pharmaxis’ lead asset could one day help treat patients with this condition.
Pharmaxis cleared to progress to Phase 2 Bone marrow cancer trial
“We are very pleased to have completed the dose-escalation phase of this study with such clear and positive findings,” Pharmaxis CEO Gary Phillips said.
Archive
Pharmaxis’ treatment to prevent wound and burns scars clears phase1 trial
“We will be investigating the safety of 3 months’ treatment with PXS‐6302, and exploring if 3 months’ treatment with PXS‐6302, at a dose that we now know will significantly inhibit an enzyme implicated in scar formation, can make a differen
Pharmaxis enters $2.5 million agreement for rights to Orbital inhaler
Pharmaxis will receive an upfront US$250,000 payment for the 12‐month option and a further US$2.5 million if Aptar decides to exercise the option. In doing so, it will also pay Pharmaxis industry-standard royalties on income received for Or
Pharmaxis welcomes data presented by University of Rochester showing PXS-5505 decreases tumour burden in pre-clinical liver cancer model
A research team at the University of Rochester Medical Center in New York State has been investigating the role of lysyl oxidase enzymes in liver cancer and whether PXS-5505 can improve the efficacy of current chemotherapy drugs by inhibiti
Pharamxis kicks off final cohort dosing to study a potential new treatment for bone marrow cancer
An effective pan‐LOX inhibitor for bone marrow cancer would open a market that is conservatively estimated at US$1 billion per annum.
Pharmaxis sells Australian distribution rights for Bronchitol and Aridol for A$2 million
Under the agreement, BTC Health will acquire marketing authorisations for both products in Australia, New Zealand, Singapore, Malaysia and Hong Kong.
Pharmaxis’ first results in bone marrow cancer trial show strong inhibition of target enzymes
The second dose cohort of the clinical trial is fully recruited and dosing of all patients has commenced at participating sites in Australian and South Korean hospitals.
Pharmaxis progresses clinical trial in bone marrow cancer
The company’s PXS-5505 multinational trial in Myelofibrosis has been cleared by the safety committee to advance to the second stage of Dose escalation study.
Charlie Teo Foundation grant to fund key research of new Pharmaxis drug to tackle brain cancer
PXS-5505 will enter pre-clinical efficacy testing for glioblastoma, the most common form of brain cancer with an average survival of only 15 months from diagnosis.
Pharmaxis secures $4.4 million in placement to support ongoing myelofibrosis and skin scarring clinical studies
The company has also strengthened its balance sheet with the sale of Bronchitol Russian distribution rights for A$2 million with annual A$1 million cost savings.
Pharmaxis announces world-first clinical trial of wound and burn scars prevention treatment
The trial will investigate the potential of PXS‐6302 treatment to transform trauma recovery by blocking the underlying fibrosis causing scar tissue.
Pharmaxis discoveries showing promise in bone marrow cancer, according to Boston University School of Medicine publication
The researchers hope that the study will contribute to the development of novel treatment options for primary myelofibrosis.
Pharmaxis unveils commercial launch of Bronchitol® (mannitol) as add‐on maintenance therapy for cystic fibrosis in the US
In addition, data from the Pharmaxis Phase 3 global clinical trial (CF303) evaluating the efficacy and safety of Bronchitol in adults with CF has been published online in the Journal of Cystic Fibrosis.
Pharmaxis enrols first patient in clinical trial for PXS‐5505, a potential new treatment for bone marrow cancer myelofibrosis
“Its potential to modify the course of the disease by directly targeting bone marrow fibrosis will make PXS‐5505 an ideal monotherapy or adjunct to approved therapies in this indication,” says CEO.
Pharmaxis chalks up major milestone with export of first shipment to US of cystic fibrosis drug Bronchitol® following FDA approval
“This represents a proud and very rare achievement for a home‐grown pharmaceutical research company,” says CEO Gary Phillips.
Pharmaxis boosts cash balance with US$7 million milestone payment from US licensee Chiesi following FDA approval of Bronchitol®
Pharmaxis is now advancing clinical development of a new cancer drug.
Pharmaxis transformational Bronchitol FDA approval extends cash runway to fund Myelofibrosis trial
The company expects to announce receipt of milestone payments and the start of sales from its Bronchitol treatment in the near-term.
Biotech companies will outline operational highlights at Proactive Biotech Webinar next Tuesday
The webinar will also be live-streamed on the Proactive YouTube channel, which can be viewed at any time following the presentations.
Pharmaxis achieves gold standard as Bronchitol granted FDA approval for US market
Australian drug discovery will now be available for cystic fibrosis patients in the USA in a “transformational” event for the company with cash flow generated to take lead pipeline drug to end of phase 2 clinical trials.
Pharmaxis receives $5 million R&D tax incentive as it progresses myelofibrosis treatment
The company is focused on the phase 1/2 clinical trial of its pan-LOX inhibitor PXS-505 in myelofibrosis and will use the tax incentive to progress the drug’s development.
Pharmaxis awarded A$1 million to progress Duchenne Muscular Dystrophy drug into the clinic
The Australian Government matched funding under the Biomedical Translation Bridge program will allow the company to take amine oxidase inhibitor PXS-4699 through to the start of human clinical trials.
Pharmaxis given FDA green light to start myelofibrosis phase 2 study
The Food and Drug Administration has completed a safety review of the company’s Investigational New Drug application for the pan-LOX inhibitor PXS-5505.
Pharmaxis has US Bronchitol launch US$7 million milestone payment brought forward
A timeline agreed with US licensee Chiesi Farmaceutici will see the US$7 million payment made upon US approval of Bronchitol by the Food and Drug Administration who have advised a Goal Action Date of November 1, 2020.
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.
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.
Pharmaxis begins phase one clinical trial of compound targeting pancreatic cancer
The clinical trial will include two stages and outcomes will be released in June 2019.
Pharmaxis well funded as potential partners assess its anti‐fibrotic mechanisms
CEO Gary Phillips says Pharmaxis’ healthy cash balance gives it time to choose between in-house and partnering options.
Pharmaxis LOXL2 program phase 2 ready after completion of 13-week toxicity studies
The results of the toxicity studies complete Pharmaxis’ scientific package of data for the LOXL2 program.
Pharmaxis resubmits new drug application for Bronchitol in the US
Bronchitol works by rehydrating the airway/lung surface and promoting a productive cough. It is used for the treatment of cystic fibrosis patients.
Pharmaxis reveals first sales of Aridol® in US following successful relaunch
Aridol is a lung function test designed to help doctors diagnose and manage asthma.
Arix Bioscience sees multiple advancements across portfolio
Since September, the group's portfolio has steamed ahead with a number of new and successful clinical trials, as well as a boost from the float of one of its companies on the Nasdaq
Arix Bioscience’s portfolio firm Autolus doses first patient in clinical trial of AUTO4 T-cell lymphoma therapy
PTCL is a form of cancer that arises in areas of the body such as lymph nodes, spleen, the gastrointestinal tract, and skin
Pharmaxis moving into phase I clinical trial of its small molecule LOX inhibitor
Pharmaxis is the first company to progress a small molecule LOX inhibitor into clinical development.
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Arix Biosciences hails phase I success of investee company Pharmaxis
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FTSE 100 closes marginally higher as PM May defends draft Brexit deal
The UK's premier share index closed up around four points at 7,038, while the FTSE 250 shed almost 248 points at 18,662.
Pharmaxis receives positive results from clinical trial of treatment for fibrotic diseases
There were no adverse safety findings and excellent drug-like properties were confirmed for the second of the LOXL2 inhibitor compounds.
Pharmaxis receives positive results from LOXL2 clinical trial
There were no adverse safety findings and excellent drug-like properties were confirmed.
A sixth sense for biotech helps Arix Bioscience turn risk into profit as portfolio value nearly doubles
Analysts at Stifel say the venture capital firm is entering its first extended period of sustained news flow with shares trading at about 45% discount to their £2.53 price target
Pharmaxis adds valuable experience with Ed Rayner appointment
Ed Rayner is an investment director for major shareholder Arix Bioscience Plc (LSE:ARIX).
Pharmaxis gains Arix Bioscience Plc as a new substantial shareholder
Arix led a $24 million share placement and will invest $14.2 million in two tranches.
Pharmaxis receives FDA approval to produce Aridol for US market
Aridol is already manufactured for the markets of Europe, Australia and South Korea.
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