REGEN BIOPHARMA, INC.
Recent Regen News Is More Powerful Than Meets the Eye
Rob Goldman
July 24, 2025
REGEN BIOPHARMA, INC. (OTC: RGBP: $0.0881)
Industry: BioPharma
COMPANY SNAPSHOT
Regen BioPharma, Inc. is focused on the immunology and immunotherapy spaces. The Company seeks to rapidly advance novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, Regen has one cleared Investigational New Drug Application and 2 others pending FDA approval.
KEY STATISTICS
- Price as of 7/23/25$0.0881
- 52 Wk High – Low$0.27 – $0.02
- Est. Shares Outstanding31.6M
- Market Capitalization$2.8M
- Average Volume55,482
- Exchange:OTCID
COMPANY INFORMATION
Regen BioPharma, Inc.
4700 Spring Street
Suite 304
La Mesa CA 91942
Web: www.RegenBiopharmaInc.com
Email: david.koos@regenbiopharma.com
Phone : 619.722.5505
INVESTMENT HIGHLIGHTS
Yesterday, Regen announced its intention to seek an Orphan Drug Designation from the FDA for its lead candidate, HemaXellerate™. Following the news, we uncovered valuable information regarding orphan drugs that indicate Regen could be a huge beneficiary if the designation is granted.
In its release, Regen noted that this award would offer significant benefits. These include a tax credit equal to 25% of qualified clinical testing expenses and up to seven years of marketing exclusivity.
Based on data we found in an orphan drug study published by the National Institutes of Health (NIH), the Company could generate substantial revenue if the therapy is awarded this designation and approved for use by the FDA. The study can be found here.
According to the study, the median orphan drug price is over $218,000 per year. By assigning this figure to potential patients, $218 million in revenue would be generated for every 1,000 patients prescribed with an FDA-approved, orphan drug.
Considering that a core guideline for designation is a low patient population (in which HemaXellerate™) would qualify, we feel good about Regen’s prospects. There are other hidden potential benefits to Regen. The study showed a strong correlation to this designation and the award of other valuable designations such as Fast Track, along with accelerated approvals. Investors should feel confident that the study data affirms our investment thesis and price target.
RECENT TRADING HISTORY FOR RGBP
(Source: www.StockCharts.com)
Senior Analyst: Robert Goldman
Rob Goldman founded Goldman Small Cap Research in 2009 and has over 25 years of investment and company research experience as a senior research analyst and as a portfolio and mutual fund manager. During his tenure as a sell side analyst, Rob was a senior member of Piper Jaffray’s Technology and Communications teams. Prior to joining Piper, Rob led Josephthal & Co.’s Washington-based Emerging Growth Research Group. In addition to his sell-side experience Rob served as Chief Investment Officer of a boutique investment management firm and Blue and White Investment Management, where he managed Small Cap Growth portfolios and The Blue and White Fund.
Analyst Certification
I, Robert Goldman, hereby certify that the view expressed in this research report accurately reflect my personal views about the subject securities and issuers. I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the recommendations or views expressed in this research report.
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