reports
- Sean Conroy
Paradigm Biopharma - Termination of coverage
Edison Investment Research is terminating coverage on Paradigm Biopharma (PAR). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our website.
- Sean Conroy
Paradigm Biopharma - Q1 results recap iPPS progress in OA & MPS
Paradigm announced Q1 results (for the quarter ending 30 September) and a A$30m capital raise to potentially extend its cash runway through to mid CY25. Management attributed increased spending in the quarter to increased clinical and recruiting activity, which translated into a higher net cash outflow from operating activities of A$22.5m (vs A$17.1m in Q423). With the PARA_OA_008 programme now concluded, as well as the upcoming completion of the mucopolysaccharidosis (MPS) VI Phase II trial and...
- Sean Conroy
Paradigm Biopharma - Disease modifying properties in iPPS Phase II
Paradigm reported favourable quantitative MRI data from the six-month analysis of the Phase II trial (PARA OA 008) evaluating a single six-week course of injectable pentosan polysulfate sodium (iPPS) treatment at 2mg/kg twice weekly in knee osteoarthritis (kOA) patients. This analysis provides more precise numerical measurements from the semi-quantitative analysis shared in April. In both studies treated patients exhibited increased cartilage thickness and volume in knee joints in patients, whil...
- Sean Conroy
Paradigm Biopharma - Durable responses observed for kOA
Paradigm has announced positive day-365 data from its Phase II trial (PARA_OA_008) assessing injectable pentosan polysulfate (iPPS) as a potentially disease-modifying treatment for knee osteoarthritis (kOA). The latest data show durable responses based on measures of pain and function, while confirming the company will be pursuing an iPPS (2mg/kg) twice-weekly regimen for six weeks across all of its clinical programmes for kOA. Based on this update, Paradigm now plans to proceed with a Provision...
- Sean Conroy
Paradigm Biopharma - Progressing toward key near-term objectives
Paradigm has shared its June 2023 quarterly update. In Q423, net cash outflow from operating activities was A$17.1m (up from A$10.3m in Q323) or A$45.2m for FY23. R&D costs were A$16.1m (versus A$9.0m in Q3) or A$47.0m for FY23, and were attributed to recruitment initiatives and new site identification for the PARA_OA_002 trial, analytical activities for the PARA_OA_008 trial as well as the canine model studies of naturally occurring osteoarthritis (OA), and clinical activities assessing iPPS fo...
- Sean Conroy
Paradigm Biopharma - Pivotal Phase III progressing as planned
Paradigm has announced the completion of patient recruitment for stage one (dose selection) of its pivotal Phase III trial, PARA_OA_002, a multi-centre (US/Australia/UK/EU/Canada), two-stage, adaptive, randomised, double-blind, placebo-controlled study to assess injectable pentosan polysulfate (iPPS) in patients with knee osteoarthritis (kOA) pain. Paradigm has efficiently recruited participants for the trial through various initiatives, such as through its partnership with NFL Alumni Health. Ma...
- Sean Conroy
Paradigm Biopharma - Bolstering the iPPS data package for OA
Paradigm is focused on the development of injectable pentosan polysulfate (iPPS) for the treatment of osteoarthritis (OA). While the company has several active human clinical trials, it is also assessing iPPS in a canine model due to the similarities in disease biology. Furthermore, since dogs have a shorter lifespan than humans, the full progression of the condition can be assessed over a condensed period. Management believes that this could be advantageous in evaluating the disease-modifying O...
- Sean Conroy
Paradigm Biopharma - Active pipeline and catalysts ahead
Paradigm has shared its March 2023 quarterly update. In Q323, net cash outflow from operating activities was A$10.3m (A$28.1m for the first nine months of FY23). R&D costs amounted to A$9.0m, attributed to ongoing recruitment and analytical activities for the PARA_OA_008 Phase II clinical trial assessing injectable pentosan polysulfate (iPPS, or Zilosul) as a potentially disease-modifying treatment for knee osteoarthritis (kOA), site operations for Phase II studies in mucopolysaccharidosis (MPS ...
- Sean Conroy
Paradigm Biopharma - Potential for disease-modifying kOA treatment
Paradigm has announced day 168 (six-month) data from the PARA_OA_008 trial, which is evaluating injectable pentosan polysulfate sodium (iPPS) as a potentially disease-modifying treatment for knee osteoarthritis (kOA). Highlights from the interim data include: structural changes in several disease features as measured by magnetic resonance imaging (MRI), potential support for disease-modifying OA drug (DMOAD) activity from trends in biomarker data, and persistent positive responses in WOMAC score...
- Sean Conroy
Paradigm Biopharma - Active year ahead with significant catalysts
Paradigm has presented its half yearly results and accounts, reflecting an active period. This included an encouraging safety review for injectable pentosan polysulfate sodium (iPPS, Zilosul) in the pivotal Phase III trial (PARA_OA_002) for patients with knee osteoarthritis (kOA) pain. The Phase II (PARA_OA_008) biomarker trial reached its primary endpoint, positioning iPPS as a potentially disease-modifying drug. In our opinion, the initiation of the confirmatory Phase III trial (PARA_OA_003) a...
- Sean Conroy
Paradigm Biopharma - Funded past near-term inflection points
Cash flow figures from Paradigm Biopharmaceuticals’ latest update show that it remains funded past key near-term inflection points. In Q223, management reported a net cash outflow from operating activities of A$7.8m (A$17.8m for the first six months of FY23), including an A$7.4m R&D tax incentive rebate, and no capital expenditure. R&D expenditure increased 54% q-o-q to A$13.2m, corresponding with ongoing recruitment and site identification for the pivotal PARA_OA_002 Phase III trial of iPPS in ...
Paradigm Biopharmaceuticals (PAR): Adapted therapies to meet unmet dem...
Edison Investment Research Limited Paradigm Biopharmaceuticals (PAR): Adapted therapies to meet unmet demand 14-Dec-2022 / 16:30 GMT/BST London, UK, 14 December 2022 Paradigm Biopharmaceuticals (PAR): Adapted therapies to meet unmet demand Paradigm Biopharmaceuticals is a late-stage Australian drug developer focused on developing injectable pentosan polysulfate sodium (PPS). The company’s most advanced clinical programme is investigating injectable PPS (iPPS, Zilosul) as a potentially disease modifying treatment for knee osteoarthritis (kOA), a globally prevalent condition ...
- Sean Conroy
Paradigm Biopharma - Adapted therapies to meet unmet demand
Paradigm Biopharmaceuticals is a late-stage Australian drug developer focused on developing injectable pentosan polysulfate sodium (PPS). The company’s most advanced clinical programme is investigating injectable PPS (iPPS, Zilosul) as a potentially disease modifying treatment for knee osteoarthritis (kOA), a globally prevalent condition with unmet medical needs. We believe Paradigm’s comprehensive Phase III programme is designed to maximise the potential of iPPS in kOA. The company is also inve...
Paradigm Biopharmaceuticals Ltd: 3 directors sold
Three Directors at Paradigm Biopharmaceuticals Ltd sold 4,431,479 shares at between 2.300AUD and 2.369AUD. The significance rating of the trade was 72/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's ...
Ford Equity International Rating and Forecast Report
Ford Equity International Research Reports cover 60 countries with over 30,000 stocks traded on international exchanges. A proprietary quantitative system compares each company to its peers on proven measures of business value, growth characteristics, and investor behavior. Ford's three recommendation ratings buy, hold and sell, represent each stock’s return potential relative to its own country market.. The rating reports which are generated each week, include the fundamental details behind...
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.