The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is rocketing today, up 21.55% in early afternoon trading.
Paradigm shares closed yesterday at $1.16 and are currently trading for $1.41. However, they climbed as high as $1.60 earlier in the day — a 38% gain on yesterday’s close.
The drug development company is focused on developing and commercialising Pentosan Polysulfate Sodium (PPS) to treat pain associated with a range of musculoskeletal disorders.
Below we look at this morning’s announcement that’s seeing the Paradigm share price surge.
What clinical trial news was announced?
Paradigm’s share price is rocketing after the company reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its phase 3 program testing the efficacy of PPS, trademarked Zilosul, to treat osteoarthritis (OA).
OA affects some 16% of the population in the developed world, with more than 72 million people in the US, EU, Canada, and Australia suffering from the affliction.
Paradigm said the FDA’s Fast Track program would help expedite its phase 3 program, providing the company with greater opportunities to interact and collaborate with the FDA.
It added that the Fast Track designation indicates the FDA acknowledges that preliminary data indicates Zilosul has the potential to address the unmet medical needs of people suffering from OA.
Commenting on the FDA’s decision, Paradigm’s interim CEO Donna Skerrett said:
This is welcome news from the US FDA as the company continues to gain momentum in site activation and participant screening across the 56 selected sites in the US. Given the need to improve therapeutic options for patients suffering from pain and loss of functionality associated with OA, we are excited to have this Fast Track Designation granted for Zilosul and the regulatory support it provides in expediting the phase 3 development program to advance this promising treatment to patients sooner.
Paradigm share price snapshot
Despite the big intraday boost today, the Paradigm share price remains down 27% so far this year. That compares to a year-to-date loss of 3% posted by the All Ordinaries Index (ASX: XAO).