Paradigm Biopharmaceuticals Ltd (ASX: PAR) shares started the week with an almighty bang.
The ASX biotech stock ended the session almost 42% higher at 46 cents.
At one stage, the biopharmaceutical company's shares were up as much as 52% to a 52-week high of 49.5 cents.
Why did this ASX biotech stock rocket?
Investors were bidding the company's shares higher today despite there being no news out of it.
Though, interestingly, the lack of news was arguably the trigger for this rampant buying, with investors deeming no news to be very good news.
The buying was so strong that it even led to the Australian stock exchange operator giving the ASX biotech stock a speeding ticket. It said:
Is PAR aware of any information concerning it that has not been announced to the market which, if known by some in the market, could explain the recent trading in its securities?
In response, the biotech said:
No, the Company is not aware of any information concerning it that has not been announced to the market which, if known, could explain recent trading in the Company's securities.
What else did it say?
Every speeding ticket that the Australian stock exchange operator issues includes a section asking for an opinion on why a certain share might be making a large and unexpected move.
The ASX biotech stock revealed that the buying could be due to the company not yet receiving feedback from the US Food and Drug Administration in relation to the submission of its revised Phase 3 clinical trial protocol for evaluating injectable pentosan polysulfate sodium as a treatment for knee osteoarthritis.
Given that it has not received any feedback so close to the review deadline, investors appear to be interpreting this as a sign that the regulator hasn't found anything wrong and is about to give the trial the thumbs up.
The company's response states:
Paradigm Biopharmaceuticals has provided an update to the ASX on October 31, 2024, announcing the submission of its revised Phase 3 clinical trial protocol to the U.S. Food and Drug Administration (FDA). The FDA's standard review period for such submissions is 30 days, concluding on November 28, 2024. As of this date 25 November 2024, the company has not received any feedback or communication from the FDA. In the absence of a response within the designated review period, Paradigm anticipates initiating start-up activities for its Phase 3 pivotal clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) as a treatment for knee osteoarthritis (OA).
There are also developments closer to home that are nearing a conclusion. It adds:
Paradigm Biopharmaceuticals also informed the ASX on October 31, 2024, that it expects a response to its Determination Application submitted to the Therapeutic Goods Administration (TGA) during the December quarter. This application is a critical step toward advancing the submission for provisional approval of iPPS for the treatment of knee OA in Australia. Achieving this determination represents significant progress in securing regulatory approval within the region.
The next few weeks should be very interesting for this biotech stock.
