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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.
On April 13, 2023, RegeneRx Biopharmaceuticals (OTCQB: RGRX) announced the enrollment of the first patient in its Phase 3 clinical trial (SEER-2) for RGN-259, aimed at treating neurotrophic keratitis (NK). The trial, conducted by ReGenTree, involves over 70 NK patients and will focus on achieving complete corneal healing.
RGN-259, containing thymosin beta 4, has shown promise in previous studies, with significant efficacy in an earlier trial involving 18 patients. The company is conducting two simultaneous trials (SEER-2 and SEER-3) to expedite the approval process. The U.S. market for NK treatment includes about 20,000 patients annually. If successful, RGN-259 could present a substantial opportunity, especially considering the only existing treatment, Oxervate, is among the costliest in the U.S.
On April 11, 2023, RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) issued a Letter to Stockholders outlining its operational strategy and development focus. The company specializes in novel therapeutic peptides, particularly Thymosin beta 4 (Tβ4), targeting tissue protection, repair, and regeneration. RegeneRx is advancing three drug candidates in clinical trials for various medical conditions and holds four strategic licensing agreements across the U.S., China, and several Asian countries, as well as the EU. The letter includes forward-looking statements regarding financial needs, clinical trials, and partnerships, highlighting inherent risks and uncertainties, particularly concerning capital requirements and the success of ongoing clinical trials.
On January 31, 2023, RegeneRx Biopharmaceuticals (OTCQB: RGRX) announced a significant scientific discovery regarding Thymosin beta 4 (Tβ4) and its potential for anti-aging therapies. Research from teams in Hungary and the U.S. demonstrated that Tβ4 can enhance cardiac cell survival and function post-injury, indicating its role in heart regeneration. The study revealed Tβ4's ability to activate epicardial progenitor cells and increase cardiac vessel formation in healthy models. This finding opens avenues for exploring Tβ4's effects on aging organs beyond the heart, potentially offering a strategy to combat aging. The full publication details are available in Int Immunopharmacol..
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced the publication of phase 3 clinical trial results demonstrating the safety and efficacy of RGN-259 eyedrops for treating Neurotrophic Keratopathy. The trial showed complete healing in 6 out of 10 patients treated with RGN-259, while only 1 out of 8 in the placebo group healed. The product aims to improve ocular comfort and has a favorable safety profile with no significant adverse effects reported. This development enhances the prospects for ongoing trials in the U.S. and EU, expected to commence this month.
RegeneRx Biopharmaceuticals (OTCQB: RGRX) has announced that its joint venture partner, HLB Therapeutics, submitted a Special Protocol Assessment (SPA) request to the U.S. FDA for a fourth phase 3 clinical trial (ARISE-4) aimed at treating dry eye disease with RGN-259. This sterile eyedrop is designed to enhance healing and reduce damage associated with dry eye syndrome. With over 1,700 subjects tested showing various efficacy levels, the ARISE-4 trial is anticipated to commence around Q2 2023, pending a 45-day FDA review period.
RegeneRx Biopharmaceuticals (OTCQB: RGRX) provides a stockholder update detailing its drug development strategy, FDA regulatory plans, and ongoing operations. The company focuses on therapeutic peptides for tissue protection and has three candidates in clinical development targeting various medical conditions. It maintains multiple strategic licensing agreements across the U.S. and Asia and holds extensive patents for its products. The company emphasizes potential risks and uncertainties related to its forward-looking statements regarding clinical trials and financial stability.
RegeneRx Biopharmaceuticals (OTCQB: RGRX) has announced a significant advancement in its clinical trials, with joint venture partner HLB Therapeutics signing a letter of intent with a global ophthalmology CRO to conduct two simultaneous phase 3 clinical trials for neurotrophic keratitis (NK) starting Fall 2022. These trials aim to expedite the process of obtaining FDA approval, requiring two successful outcomes. RGN-259, the candidate under trial, has shown promising efficacy in preliminary studies, targeting a market with about 20,000 new NK patients annually in the U.S. The company plans to apply for a Special Protocol Assessment for an additional dry eye trial soon.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) reported promising findings on the therapeutic efficacy of Thymosin Beta 4 (Tβ4) combined with vasoactive intestinal peptide (VIP) in treating diabetes-induced changes in human corneal epithelial cells. Presented at the ARVO 2022 meeting in Denver, the research, funded by several notable institutions, highlights Tβ4's role in enhancing barrier integrity without side effects. RegeneRx focuses on developing innovative therapeutic peptides for tissue protection and regeneration, with three candidates in clinical development and strategic licensing agreements globally.
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