Last $0.15 USD
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Volume 31.3K
As of 5:10 PM 11/28/14 All times are local (Market data is delayed by at least 15 minutes).

regenerx biopharmaceuticals (RGRX) Snapshot

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regenerx biopharmaceuticals (RGRX) Details

RegeneRx Biopharmaceuticals, Inc., a biopharmaceutical company, focuses on the discovery and development of molecules for tissue and organ repair. The company develops its product candidates based on Thymosin beta 4 (Tß4), an amino acid peptide. It develops RGN-259, a topical eye drops that that has completed the Phase IIa exploratory clinical trials and for the regeneration of corneal tissues damaged by injury, disease, or other pathology; and RGN-352, an injectable formulation, which has completed Phase I clinical trials and is intended to treat cardiovascular diseases, central and peripheral nervous system diseases, and other medical indications treated by systemic administration. The company also develops RGN-137, a topical gel that is in Phase II clinical trials and intended for the treatment of epidermolysis bullosa, pressure ulcers, and venous stasis ulcers. It also seeks to identify and evaluate Tß4 peptide fragments and derivatives for use as components in cosmeceutical and consumer products. RegeneRx Biopharmaceuticals, Inc. has a strategic partnership with Defiante Farmaceutica S.A. for the development and marketing of RGN-137 and RGN-352 for specified indications in Europe and other countries. The company was formerly known as Alpha 1 Biomedicals, Inc. and changed its name to RegeneRx Biopharmaceuticals, Inc. in 2000. RegeneRx Biopharmaceuticals, Inc. was founded in 1982 and is headquartered in Rockville, Maryland.

5 Employees
Last Reported Date: 04/4/14
Founded in 1982

regenerx biopharmaceuticals (RGRX) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $65.0K
Compensation as of Fiscal Year 2013.

regenerx biopharmaceuticals (RGRX) Key Developments

RegeneRx Biopharmaceuticals Reports Thymosin Beta 4 is Cardioprotective in Pulmonary Hypertension/Heart Failure Model

RegeneRx Biopharmaceuticals Inc. reported new published data demonstrating that Thymosin beta 4 (TB4) can be used effectively to prevent or reduce heart failure. In a standard murine model of pulmonary hypertension (induced by a toxic plant alkaloid) that causes compensatory right heart hypertrophy, TB4 significantly reduced the systolic pressure and right ventricular hypertrophy when compared to animals that were not treated with TB4. This study was reported in the scientific journal PLOS ONE, OI:10.1371/journal.pone.0110598 November 20, 2014. The company announced that the study provides additional evidence that TB4 could be used as a vasculoprotective agent for the treatment of pulmonary hypertension-induced heart failure and confirms other independent studies showing the reduction of damage and improvement of function in both acute and sub-chronic cardiac models.

RegeneRx Biopharmaceuticals, Inc. Announces Management Changes

RegeneRx Biopharmaceuticals Inc. announced that the company has retained Alan Klein, MBA, on a part-time basis as Chief Business Officer (CBO) primarily responsible for product licensing, in particular RGN-352, as well as financing initiatives, commercialization modeling, grant applications, and intellectual property development. Mr. Klein previously held senior positions at public and private companies, including Quintiles International, Gene Logic, and Sequella Inc. He has been responsible for generating numerous out-licensing, in-licensing, and M&A transactions, valued at over $1 billion in aggregate, with major biotech and pharmaceutical companies throughout the world. On October 31, 2014, Dane Saglio submitted his resignation as Chief Financial Officer of the company. Mr. Saglio will perform the duties of principal financial officer of the company until the filing of the company's Quarterly Report on Form 10-Q for the third fiscal quarter of 2014. Mr. Saglio will remain as a consultant to the company after the filing date.

RegeneRx Allows to Proceed with Phase 3 Using RGN-259 Eye Drops for the Treatment of Neurotrophic Keratopathy

RegeneRx Biopharmaceuticals Inc. announced that it met with the FDA in September and as a result of the meeting may begin Phase 3 to evaluate RGN-259 preservative-free eye drops for the treatment of patients with neurotrophic keratopathy (NK), an orphan disease of the cornea. The Company believes clinical trials could be started by mid-2015. As is typically required by FDA, the Company is planning to conduct two pivotal phase 3 trials, anticipated to total less than 90 patients to confirm the safety and efficacy of RGN-259 for NK. It is estimated that each trial will take approximately six to nine and months will be designed based on the results of an earlier trial conducted by ophthalmologists at Wayne State University and Beaumont Hospital in Detroit, MI. In moving from Phase 2 to Phase 3 the Company, through its contractors, intends to expand CMC efforts (chemistry, manufacturing, and controls) as required by FDA regulations. RegeneRx has been working with Ora Inc., a global ophthalmic research and product development firm, to develop the regulatory pathway and implement the clinical development plan on this orphan indication. RegeneRx recently retained Ora as CMC consultant and has begun evaluating manufacturers with Phase 3 and commercial production capabilities for this product. The Company plans to submit a CMC plan and final clinical protocol to FDA at the earliest practicable time.


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