otcmkts:rgrx – RegeneRx Biopharmaceuticals, Inc Outlook For 2021

otcmkts:rgrx is an emerging company and a stock to watch. RegeneRx Biopharmaceuticals, Inc, focuses on developing a therapeutic peptide, thymosin beta 4, to protect organ tissue.

The company is developing a revolutionary product, RGN-259, a topical eye drop for corneal generation that has been damaged by disease or injury. Other products being developed include RGN-352, an injectable formula for the treatment of cardiovascular diseases, and RGN-137, a topical gel to treat dermal wounds and reduce scar tissue. The company has a partnership with GtreeBNT Co.Ltd and Lee’s Pharmaceutical Group. The company was formed in 1982 and is based in Rockville, Maryland.

otcmkts:rgrx is primarily focused on the development of innovative therapeutic peptides. Its leading product is Thymosin beta 4 for tissue and organ protection, regeneration, and repair.

RegeneRx already has three drug candidates in clinical development for cardiac/TBI, dermal indications, and ophthalmic.

It also has four active licensing agreements throughout the U.S., Australia, China, and Pan Asia. The company also has patents covering its products worldwide. RegeneRx’s product RGN-259, an ophthalmic eye drop, has recently completed phase 3 for dry eye syndrome In the United States and expects to report results for the ARISE-3 clinical trial early part of 2021.

This is a publicly-traded company ticker symbol (OTCQB: RGRX).

The company has numerous patents worldwide for its products, through its partners and independently. RegeneRx has active partnerships worldwide, including the U.S., China, Canada, Pan Asia, and the E.U.

The company’s partners have made significant progress in each of the territories with their key product, RGN-259. The company has already initiated stage 2 and phase 3 clinical trials. The company’s other primary assets are currently awaiting phase 3 completion in the U.S. before they move into the E.U. to maximize the value in the E.U. market.

Business Development

The company is actively seeking partnerships with companies that have development and commercialization interests throughout pharmaceutical therapeutic fields. RegeneRx has already outsourced licensing to key candidates and partners with the finance and expertise to develop the drug candidates. Its key partners are developing its 4 major territories with no financial obligation to their company. The company has gained rights in some territories for their drug candidates to maximize their potential value when success has been achieved.

In August 2017, the company amended its license agreement with GtreeBNT for the drug candidate RGN-137.

It enables the company to expand into Europe, Australia, Japan, Canada, and South Korea. Regarding their other drug candidate, RGN-259, the company will await results from the current ophthalmic clinical program in the U.S. before initiation in the E.U. The main focus is to maximize the value of the assets. The company is seeking partners for the RGN-352 to develop and finance its capabilities.

Throughout the years, the company has gathered strategic partners and licenses, enabling them to enter significant territories worldwide. Their drug candidates achieving success and clinical trials for the commercialization and expansion of their assets.

In 2017 the company licensee for RGN-137 GtreeBNT, acting through its subsidiary Lenus Therapeutics, LLC. They received permission from the U.S. for the FDA to sponsor a phase 3 clinical trial for RGN-137 to treat epidermolysis bullosa, a genetic disease causing severe blistering of the skin. Under the agreement with GtreeBNT, RegeneRx expanded into the E.U. and other territories worldwide.

The company is currently trading at 0.1900 and has increased by 2.65% at the time of this article. The 52-week range is between 0.1800 – 0.8200 with a volume of 13,616. There is no P.E. Ratio available.

The company does not have an earnings date at this time and does not offer a dividend yield. otcmkts:rgrx market capitalization is 25.374 Million.

otcmkts:rgrx Enrolls the Last Subject in Phase 3 Dry Eye Trial

The company announced that its joint venture ReGenTree LLC enrolled the last 700 subjects’ phase 3 clinical trials for dry eye syndrome. The treatment completion and follow-up will be towards the end of November 2020.

The trial ARISE-3 is designed to assess the efficiency and safety of RGN-259 eye drops, compared to a placebo after two weeks of treatment with 700 subjects with dry eye syndrome. This innovative eye drop has demonstrated fast efficiency in previous clinical trials. The drug does not show any adverse effects. Unlike many other approved products, it is safe and well-tolerated. The other approved medicines can cause negative side effects in many cases.

otcmkts:rgrx Last Patient, Last Visit Completed

The company announced that they had completed the ARISE-3 phase 3 clinical trial, with their last patent in its 700 subjects. The project is being sponsored by ReGenTree, LLC, the joint venture company owned by RegeneRx.

J.J. Finkelstein, president and chief executive, commented. otcmkts:rgrx are pleased to report the completion of the ARISE-3 trial, with the follow-up with the last patient, during the challenging time of the pandemic. Our next step is to analyze the data to determine the trial results.

GtreeBNT announced major intellectual property rights, including patents for composition, manufacturing, and formulation of RGN-259 eye drops. The drug candidate has been reclassified as a biologic requiring a Biologics License Application instead of a new drug application. When the FDA approves this, it will have 12 years of market exclusivity.

More About ReGenTree, LLC

This is a joint venture company owned by RegeneRx and GtreeBNT Co., Ltd. The company’s primary focus is to develop RGN-259 in the U.S. and Canada for ophthalmic indications. The company has already completed 2 phase 3 studies in the U.S. for dry eye syndrome. The organization is currently conducting a phase 3 study called ARISE-3.

otcmkts:rgrx JV Locks Clinical Trial Database for Phase 3

The company announced that phase 3 of the ARISE-3 trial had been database locked after collecting data from patients from 20 U.S. clinical sites who participated in the study. The database lock is a point before unmasking the trial, and no patient information can be modified.

ReGenTree LLC is sponsoring the clinical trial and will unmask the study, including the biostatistical analysis’s endpoint and clinical protocol.

GtreeBNT previously stated that it already secured intellectual property rights and patents for RGN-259 eye drops.

GlobalData, a famous market research publisher globally. Estimates that the dry eye market will reach $11.1 billion by 2028 throughout nine significant countries, including the U.S., according to its market research conducted in May 2020. The company also expects that RGN-259’s unique mechanism of action will capture a significant market share after its market launch.

J.J. Finkelstein, president, chief executive of RegeneRx, stated. otcmkts:rgrx are pleased that the ARISE-3 database is locked and being statistically analyzed. The company hopes that the outcome will be positive, and topline results will be released soon. A positive outcome is crucial to this important clinical trial.

otcmkts:rgrx Topline Results of ARISE-3 Dry Eye Trial

The company announced that the ARISE-3 clinical trial for evaluating RGN-259 eyedrops to treat dry eye treatment did not meet the outcome measures. They discovered that the report saw efficiency for improving ocular grittiness, one of the secondary symptom’s endpoints in the trial. the report shows significant improvements a few weeks after treatment.

RGN-259 also demonstrated safety in the treatment of dry eye syndrome and was consistent with previous clinical trials. In the clinical study, there were no adverse events, only mild to moderate.

The data analysis gathered for RGN-259 shown in 3 clinical trials by RegeneRx, and GtreeBNT will be explored with the FDA using pooled data. They will be discussing a detailed plan for more clinical studies if required.

J.J. Finkelstein president and chief executive, commented. Even though the trial did not meet the primary outcome measures, there were improvements in our favor’s symptom effects. RGN-259 improvements of dry eye syndrome have been observed in phase 3 clinical trials. Further analysis is ongoing. The company will look forward to completing the reporting results, analysis, and meeting with the FDA shortly.

otcmkts:rgrx is primarily focused on the development of innovative therapeutic peptides. Its leading product is Thymosin beta 4 for tissue and organ protection, regeneration, and repair.

The company already has three drug candidates in clinical development. It also has four active licensing agreements throughout the U.S., Australia, China, and Pan Asia.

RegeneRx has several patents and licenses for its drug candidates through its partners, covering them globally. otcmkts:rgrx product RGN-259, an ophthalmic eye drop, has recently completed phase 3 for dry eye syndrome In the United States.

RegeneRx has already outsourced licensing to key candidates and partners with the finance and expertise to develop the drug candidates. The company has gained rights in some territories for their drug candidates to maximize their potential value when success has been achieved.

We discovered a significant advancement for the company when its joint venture ReGenTree LLC, enrolled the last 700 subjects in phase 3 clinical trials for dry eye syndrome. This innovative eye drop has demonstrated fast efficiency in previous clinical trials.

The company then completed the ARISE-3 phase 3 clinical trial for the treatment of dry eye syndrome. otcmkts:rgrx, the next step is to analyze the data to determine the trial results. When the FDA approves this, it will have 12 years of market exclusivity.

We then discovered the news from GlobalData, a popular market research publisher globally, estimating that the dry eye market will reach $11.1 billion by 2028 throughout nine major countries. Its market research concluded that it would expect that RGN-259’s unique mechanism of action will capture a significant market share after its market launch.

Finally, we discovered the results from ARISE-3 Dry Eye Trial. The results did not meet primary requirements, but RGN-259 also demonstrated safety in treating dry eye syndrome and was consistent with previous clinical trials. In the clinical study, there were no adverse events, only mild to moderate.

otcmkts:rgrx Further analysis is ongoing in ARISE-3 Dry Eye Trial. The company will look forward to completing the reporting results, analysis, and meeting with the FDA soon.

Even though the results did not initially meet the FDA approval, the company will continue to amend the drug candidate’s effectiveness and treatment to treat dry eye syndrome. Its data, which has been previously gathered through its past trials, will confirm the efficacy of the treatment and conduct more clinical trials if necessary.

If RegeneRx can find success and approval with RGN-259, it will obtain a market share of $11.1 billion industry by 2028. This is undoubtedly a company to add to your watchlist, showing potential growth with its unique drug candidates Globally.

If you enjoyed otcmkts:rgrx, you might also enjoy reading otcmkts:drrsf, a company actively exploring mining properties for phosphate concentrate. Discover the company’s outlook for 2021 and how they are scaling their operation for global demand.