Investors who may be hunting for pharmaceutical stocks this morning may do well to turn their attention to RegeneRx Biopharmaceuticals Inc (OTCMKTS:RGRX). The company was in the news yesterday after it provided an update with regards to HLB Therapeutics, which is its joint venture partner and licensee.
Trading Data
On Monday, RGRX stock lost 0.22% to $0.1757 with 78.08K shares, compared to its average volume 21.89K shares. The stock moved within a range of $0.1600 – 0.1757 after opening trade at $0.1650.
RegeneRx Licensee Submits Special Protocol Assessment to FDA for 4th Phase 3 Clinical Trial for Dry Eye Disease
It reported that HLB had made an announcement yesterday with regards to the fact that it had made a submission to the United States Food and Drug Administration for requesting a Special Protocol Assessment. The request is for a thorough discussion as well as assessment with regards to the fourth phase clinical trial for the treatment of dry eye disease.
The product in question that is going to be the subject of the discussion and assessment is RGN 259. It is an eye drop that is free of preservatives and is sterile as well. The product is being developed by ReGenTree, which is the joint venture that has been formed by RegeneRx Biopharmaceuticals Inc and HLB Therapeutics.
The developments from yesterday were important ones and it is going to be interesting to see if it leads to any traction for the RegeneRx Biopharmaceuticals stock in the coming days or not.
Key Quote
“In accordance with our SPA request, we have submitted to the FDA a briefing document summarizing our ARISE-1, -2, and -3 clinical data, including efficacy parameters and questions related to the clinical development of RGN-259 dry eye, along with the ARISE-4 protocol and statistical analysis plan. It is expected that the detailed direction and agreement given by FDA in advance by using the SPA process will help the company’s development strategy for the approval of RGN-259. Considering the initiation of this process, we expect that the ARISE-4 trial will begin around the second quarter of 2023,” according to HLB Therapeutics.
Technical Data
RGRX stock is trading above the 20-Day and 50-Day Moving averages of $0.17 and $0.16 respectively. Moreover, the stock is trading above the 200-Day moving average of $0.18.
