RegeneRx Biopharmaceuticals Inc (OTCMKTS:RGRX) Is Adding More Indications For RGN-259

RegeneRxBiopharmaceuticals Inc (OTCMKTS:RGRX) is down 10%. The company had previously closed at $0.20 but is now at $0.18. This could be a good time for investors to buy stock as they would get it at a lower price.

Trading Data

On Wednesday, RGRX stock slid 10% to $0.18 with more than 24K shares, compared to its average volume of 38K shares. The stock moved within a range of $0.1750 – 0.1900 after opening trade at $0.1750.

About RegeneRx Biopharmaceuticals

RegeneRx is a company whose primary goal is to develop thymidine beta 4. This compound is a therapeutic peptide that could regenerate, repair, and protect organs and tissue. RegeneRx is also working on RGN-259. This substance can generate corneal tissues that have been eroded by disease or damaged by an injury. Other therapies the colony is developing include RGN-137 for scar reduction and RGN-352 for heart pathologies.

The company’s primary operations are in Rockville, Maryland. While its primary operations are in the U.S, RegeneRxhas partnerships in the E.U, Pan Asia, China, and Canada. These partners have conducted phase II and III trials for its ophthalmic drug.

RegeneRx Licensee to Expand Phase 3 Clinical Trial Program with RGN-259

RegeneRx recently announced that its partner HLB Therapeuticswould add more indications for RGN-259, a compound in its ophthalmic pipeline. These indications include Dry Eye Disease (DED) and Neurotrophic Keratopathy (NK). The company will start trials for these indications in November 2022. The U.S JV ReGenTree LLC will fund them.

RegeneRx notes that while it has previously conducted trials on DED, it now intends to conduct them simultaneously with NK. The company will also apply for Special ProtocolAssessment for DED with the Food and Drug Administration (FDA) in October. This move would allow the FDA to fake part in the stage of the study, thus understanding the drug’s efficacy in treating DED.

ReGenTree also intends to conduct two Phase III trials for NK simultaneously, allowing the company to meet the FDA’s requirement for approval. The FDA requires two different trials on therapies before it can authorize it. The goal of the study will be to confirm the efficacy of RGN-259.

Each of the trials will include 60 patients. The company hopes to recruit patients for the trial starting in November 2022. RegeneRx believes that RGN-259 could potentially cure several ophthalmic diseases, thus improving the quality of life for its patients.

Key Quote

“We are pleased HLBT is moving forward with both NK and DED clinical trials with RGN-259 as we believe our product candidate has significant potential as an important therapeutic modality for numerous ophthalmic disorders.  Accelerating NK clinical development by simultaneously conducting two trials will speed up the process while also working with the FDA under a SPA to refine our approach to DED. I believe this strategy indicates that HLBT is fully committed to RGN-259’s clinical development in the field of ophthalmology,” stated J.J. Finkelstein, RegeneRx’s president and chief executive.

Technical Data

RGRX stock is trading below the 20-Day and 50-Day Moving averages of $0.18 and $0.18 respectively. Moreover, the stock is trading below the 200-Day moving average of $0.19.