Regen BioPharma Prepares Response For FDA Regarding Its Orphan Drug Application for HemaXellerate
Regen Biopharma, Inc. Common (RGBP)
NASDAQ:AMEX Investor Relations:
regenbiopharmainc.com/investor-relations.html
Company Research
Source: GlobeNewswire
SAN DIEGO, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP) today announced the Company is in the process of addressing comments received by the U.S. Food and Drug Administration (FDA) in connection with the Company’s recent submission of an Orphan Drug Application (ODA) to the FDA for HemaXellerate, its lead therapeutic candidate for the treatment of aplastic anemia. Aplastic anemia is a rare and potentially life-threatening bone marrow disorder. The Company is confident that it will be able to satisfactorily address any comments received. HemaXellerate is a novel, cell-based therapeutic designed to stimulate bone marrow activity and restore hematopoietic function. The submission of the ODA marks a key milestone in Regen BioPharma’s mission to develop innovative therapies for patients with limited treatment options. “This application represents a major step forward in our commitment to advancing regenerative therapies for rare diseas
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News
- Regen BioPharma Update on Orphan Drug Application for HemaXellerate Will Be Presented At Emerging Growth Conference on September 24, 2025 [Yahoo! Finance]Yahoo! Finance
- Regen BioPharma Update on Orphan Drug Application for HemaXellerate Will Be Presented At Emerging Growth Conference on September 24, 2025 GlobeNewswire
RGBP
Sec Filings
- 12/4/25 - Form QUALIF
- 11/17/25 - Form 1-A
- 11/13/25 - Form 8-K
- RGBP's page on the SEC website