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RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) is a publicly traded, clinical-stage biopharmaceutical company specializing in the field of tissue protection, repair, and regeneration. The company's mission is to develop novel pharmaceuticals aimed at safeguarding and restoring tissue and organ function impaired by disease, trauma, or other pathological conditions.
RegeneRx's core focus is on advancing three distinct drug candidates through clinical development, each based on the company's proprietary thymosin beta 4 (Tβ4) technology. These candidates are:
- RGN-137: A topical gel intended for dermal wound healing.
- RGN-259: An ophthalmic solution aimed at treating dry eye syndrome and other corneal disorders.
- RGN-352: An injectable formulation designed for systemic therapeutic applications.
Currently, RegeneRx holds more than 75 issued patents or pending patent applications worldwide, which serve to protect multiple indications and applications for its product candidates.
RegeneRx has established significant partnerships in three major territories: the United States and Canada, China, and Pan Asia. These collaborations have been instrumental in advancing the clinical trials for RGN-259, particularly in the field of ophthalmology. Importantly, the financial burden of these developments is being borne by RegeneRx's partners, facilitating progress without imposing additional financial strain on the company.
Recent developments include a 1-for-100 reverse stock split that was effected on August 15, 2023. This strategic move aims to streamline the company's stock structure and improve its market position. Additionally, RegeneRx has filed Form 15 to suspend and terminate its reporting obligations with the SEC, a step that may influence its public trading status.
For further information, stockholders and interested parties are encouraged to visit www.regenerx.com or contact Mr. J.J. Finkelstein at 301.208.9191 or via email at jjfnk@regenerx.com.
RegeneRx Biopharmaceuticals (OTCQB: RGRX) announced a pre-BLA meeting with the FDA on February 28, 2022, regarding its joint venture partner HLB Therapeutics' RGN-259 for treating dry eye syndrome. Attendees included ReGenTree management and FDA specialists. The company expects to receive meeting minutes within 30 days to ascertain the next clinical steps. RegeneRx is focused on developing therapeutic peptides for tissue repair and currently has multiple clinical candidates in development.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced that Dr. Hynda K. Kleinman will receive the Second Biennial Dr. Gertrude Herzfeld International Jewish Woman of the Year Prize for Health. Dr. Kleinman, a consultant for RegeneRx, is recognized for her contributions to health and women's advancement in science. With over 440 publications and multiple patents, her work includes research on thymosin beta 4, now in phase 3 trials. The award ceremony is scheduled for March 6, 2022, at the Royal College of Surgeons in Edinburgh.
RegeneRx Biopharmaceuticals announced that Chinese research confirmed Thymosin beta 4 (Tβ4) protects corneal cells from ethanol damage and promotes wound healing. Ethanol, used in ophthalmic surgeries, can cause significant cell damage. The study demonstrated Tβ4's efficacy in in vivo and in vitro models, supporting the development of RGN-259 for ophthalmic conditions. RGN-259 has shown quick symptom relief for dry eye syndrome with minimal side effects and has completed three phase 3 trials, progressing through FDA regulation via the ReGenTree LLC joint venture.
On January 12, 2022, RegeneRx Biopharmaceuticals (OTCQB: RGRX) announced a regulatory progress update for RGN-259, a drug focused on tissue protection and regeneration. The update was published on the company's website, providing stakeholders with insights into the status of RGN-259's development. This move is part of RegeneRx's ongoing efforts to advance its clinical-stage drug programs, aiming to enhance the treatment outcomes for patients.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced that the U.S. FDA has accepted a request for a pre-BLA meeting for RGN-259, aimed at treating dry eye syndrome. This meeting, scheduled for February 28, 2022, will focus on discussing the contents and acceptability of the upcoming BLA application. RGN-259 has demonstrated significant efficacy and safety in clinical trials involving over 1,600 patients. The product is positioned to quickly alleviate symptoms of dry eye syndrome without common side effects.
RegeneRx Biopharmaceuticals, Inc. (RGRX) announced that its joint venture, ReGenTree LLC, has submitted a request for a pre-BLA meeting with the U.S. FDA regarding its product candidate RGN-259 for dry eye syndrome. This meeting will address the anticipated BLA's format and content. The company has collaborated with FDA consulting firms to prepare for this request. If approved, the meeting is expected to occur by the end of January 2022. RGN-259 has shown positive results in clinical trials, quickly alleviating dry eye symptoms without significant side effects.
RegeneRx Biopharmaceuticals (OTCQB: RGRX) announced the results of its phase 3 clinical trial of RGN-259 for treating neurotrophic keratitis will be presented at the American Ophthalmology Association meeting on November 12-15, 2021. The trial was halted due to slow patient recruitment, completing treatment for only 18 of 46 patients. Initial results showed that 60% of RGN-259 patients achieved complete corneal healing compared to 12.5% in the placebo group. Statistical analyses indicated promising outcomes, with key endpoints demonstrating significance. RGN-259 has FDA orphan drug status.
RegeneRx Biopharmaceuticals (OTCQB: RGRX) announced significant findings from a study on Thymosin Beta 4 (Tβ4), indicating its potential for diagnosing and treating acute kidney injury in sepsis patients. The study observed 191 ICU patients and found that lower Tβ4 levels correlated with increased mortality and poorer prognosis. Tβ4 could be critical in early assessment and inflammation reduction in sepsis patients. Given rising sepsis cases in the U.S., this research may enhance treatment options for a condition with high mortality rates.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced a research paper showing Thymosin Beta 4's (Tβ4) positive effects on Alzheimer's Disease in mouse models. The study indicated that Tβ4 reduced amyloid beta deposits, improved neuronal function, and exhibited anti-depressant-like effects. Researchers noted Tβ4's ability to down-regulate inflammatory pathways, supporting its role in treating neurological disorders. The study underscores the potential of Tβ4 as a therapeutic agent for serious neurological diseases, particularly in relation to Alzheimer's and depression.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced the acquisition of its licensee, GtreeBNT, by HLB Group, a Korean biopharmaceutical firm, for approximately US$80 million in new stock and convertible bonds. This capital infusion aims to expedite ongoing clinical trials and new drug approvals, with a focus on RGN-259. The new management is expected to be appointed on October 29, 2021, and further updates will be shared at RegeneRx's Annual Stockholder Meeting on November 10, 2021.
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