The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price has strongly rebounded after hitting a 52-week low of $1.76 last week. This comes as the biopharmaceutical company released two positive announcements in the past few days.
At the time of writing, Paradigm shares are up 11.88% to $2.26 apiece. It’s worth noting that this means its share price is also up almost 25% since last Tuesday.
What’s driving Paradigm shares higher?
Investors appear to have found the bottom of the Paradigm share price following its recent surge.
During market trade on Friday, the company released a positive update.
Paradigm stated that it received an Australian ethics approval for its pivotal phase 3 clinical trial, PARA_OA_002. The study is aiming to assess treatment of pentosan polysulfate sodium (PPS) against placebo on participants with Knee Osteoarthritis Pain.
Patient recruitment and screening are yet to commence until later this year. The company has identified several sites to conduct the Australian arm of its clinical study.
The other announcement came yesterday, with Paradigm revealing that there has been a response from the United States Food and Drug Administration (FDA). This is in relation to its Investigational New Drug (IND) application to begin the United States arm of the study.
According to the notice, the FDA posed just one question about the adrenal gland function. A preclinical finding in the adrenal gland had been indicated in rats only but not in dogs. Paradigm noted that it has not seen a malfunction of the adrenal gland by itself or bene pharmaChem.
As such, the FDA has requested modifications to the company’s adrenal screening and mitigation plan.
Paradigm plans to amend its clinical trial protocol, and respond to the FDA within the next week.
The company’s CEO, Paul Rennie said that he’s confident that the FDA and Paradigm have attained a pathway to commence a phase 3 clinical trial in the United States.
About the Paradigm share price
It has been a whirlwind 12 months for Paradigm shares, reaching highs of $3 late last year, before treading lower. Since September 2020, its shares have fallen around 6%, with year-to-date down 11%.
Based on today’s price, Paradigm presides a market capitalisation of roughly $513.5 million and has approximately 227 million shares outstanding.