Paradigm Biopharmaceuticals (ASX:PAR) - Chairman & CEO, Paul Rennie
Chairman & CEO, Paul Rennie
Source: Paradigm Biopharmaceuticals
The Market Online - At The Bell

Join our daily newsletter At The Bell to receive exclusive market insights

  • Paradigm Biopharmaceuticals (PAR) has told shareholders that there will be a delay in its proposed phase three osteoarthritis clinical program
  • The late-stage drug development company had expected to report the top-line results from the trial of its Zilosul drug before the end of 2022
  • However, due to a COVID-19 delay in the written response from the Food and Drug Administration (FDA) Type C meeting, the results are now scheduled for the first quarter of 2023
  • Depending on the feedback from the FDA, Paradigm may also increase the number of participants in the proposed trial
  • Shares have been trading 3.45 per cent higher at $2.70 at 10:35 am AEDT

Paradigm Biopharmaceuticals (PAR) has told shareholders that there will be a delay in its proposed phase three osteoarthritis clinical program.

The late-stage drug development company had expected to report the top-line results from the trial of its Zilosul drug before the end of 2022.

However, due to a COVID-19 delay in the written response from the U.S. Food and Drug Administration (FDA) Type C meeting, the results are now scheduled for the first quarter of 2023.

Paradigm submitted the relevant documents to the FDA on July 20, 2020, and expects to receive a response shortly.

Depending on the feedback from the FDA, Paradigm may increase the number of participants in the proposed trial.

Paradigm will share the details of the study timeline and participant numbers, following the anticipated receipt of feedback, at its R&D day on December 21, 2020.

Shares have been trading 3.45 per cent higher at $2.70 at 10:35 am AEDT.

PAR by the numbers
More From The Market Online
AI image of a scan on kidneys

Dimerix links up with US NEPTUNE network to boost recruitment for FSGS study

Dimerix Ltd is set to partner with a key research network at the University of Michigan…
Blind person with guide dog

Biotech stock PYC doses first patient in rare blindness-causing disease trial

PYC has dosed its first patient in a clinical trial seeking to ameliorate symptoms of Autosomal…
Image of a brain

Emyria, UWA seek commercialisation of compounds to treat PTSD and Parkinson’s

Emyria and the University of Western Australia have formed a partnership to secure global rights to…
Image of a baby's brain

FDA awards Argenica two key designations for drug candidate targeting infant brain injury

Argenica Therapeutics Ltd has received two key designations from the US Food and Drug Administration for…