RegeneRx Biopharmaceuticals, Inc. (RGRX) is focused on the development of novel therapeutic peptides, including Thymosin beta 4 and its constituent fragments, for tissue and organ protection, repair and regeneration.
The company currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world.
Rodman & Renshaw initiates coverage on RGRX last week with 'buy' rating
Last week, RGRX announced that Rodman & Renshaw, a unit of H.C. Wainwright & Co., has initiated coverage of the company with a buy rating and a 12-month price target of $2 per share, Mar. 14 press release stated. The report is authored by Raghuram Selvaraju, Ph.D. and Yi Chen, Ph.D., CFA.
"In view of the unmet medical need in dry eye syndrome, the massive market opportunity, and the positive results of RGN-259 observed thus far, we believe that RegeneRx, with its current enterprise value of $45M, is significantly undervalued."
To access the report, visit: http://finance.yahoo.com/news/rodman-renshaw-initiates-coverage-regenerx-132000089.html, and click on the link to access the report at the bottom of the first paragraph.
Progress in the clinic
The company also recently announced that its U.S. joint venture with G-treeBNT, ReGenTree LLC, completed enrollment of its Phase 2b/3 dry eye trial in the U.S.
The trial is testing RGN-259 (Thymosin beta 4), a sterile, preservative-free eye drop developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders.
"Completion of enrollment for the dry eye study marks a key milestone," said RGRX's president and CEO J.J. Finkelstein in a Jan. 29 press release. "Everyone involved in the study is looking forward to the efficacy analysis and toward commercial development of RGN-259 for this underserved market. Positive results should also have a significant impact in the development cycle for our product candidate in Asia, Europe, and other markets throughout the world, as well as in its development for other ocular indications."
RGRX posts positive final results from exploratory Phase 2 clinical trial
The news on the enrollment came on the heels of a Dec. 23 press release, in which RGRX announced that its joint venture with G-treeBNT, ReGenTree LLC, posted final results from the first placebo-controlled, double-masked, exploratory Phase 2 clinical trial using RGN-259 eye drops in patients with severe dry eye.
According to the Dec. 23 press release, the data "demonstrated statistically significant improvements of corneal damage and ocular discomfort (signs and symptoms) in patients with severe dry eye, meeting the trial's key efficacy objectives. Moreover, improvements were seen at 28 days after cessation of treatment, supporting durability of the treatment. Other improvements seen in the trial included tear film breakup time and increased tear volume production. There were no adverse events."
The pilot study was conducted in 9 patients (18 eyes) with severe dry eye, mostly associated with graft vs. host disease (GvHD) and Sjogren's syndrome, at Kresge Eye Institute of Wayne State University School of Medicine and Michigan Corneal Consultants in Detroit Michigan.
"TB4 [the active ingredient in RGN-259 eye drops] is proving to be an effective treatment for dry eye in humans," the Dec. 23 press release stated. "It improves the signs and symptoms in patients with severe dry eye and is relatively fast and long acting compared with other treatments in current use. Future trials will need to include a larger cohort of patients and test additional doses for efficacy."
To learn more about RGRX, visit: http://www.regenerx.com/wt/home/index
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