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Posted On: 09/16/2025 8:26:09 AM
Post# of 5055
$RGBP Regen BioPharma Prepares Response For FDA Regarding Its Orphan Drug Application for HemaXellerate
https://www.globenewswire.com/news-release/20...erate.html
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 diseases,” said Dr. David Koos, Chairman and CEO of Regen BioPharma. “Receiving orphan drug designation would provide important regulatory and commercial advantages as we continue clinical development of HemaXellerate.”
Orphan drug designation is granted by the FDA to drugs and biologics intended to treat rare diseases affecting fewer than 200,000 people in the United States. If granted, the designation provides benefits such as seven years of market exclusivity upon approval, tax credits for clinical testing, and exemption from certain FDA application fees.
Aplastic anemia is characterized by the failure of the bone marrow to produce sufficient blood cells, leading to fatigue, infections, and uncontrolled bleeding. Current treatment options are limited, and many patients do not respond adequately to standard therapies.
HemaXellerate, an autologous mesenchymal stem cell product, is expected to restore hematopoietic stem cell function and reverse the effects of aplastic anemia-induced bone marrow suppression. Regen BioPharma plans to initiate Phase I clinical trials shortly.
“We believe HemaXellerate has the potential to significantly improve the lives of patients suffering from this debilitating condition,” added Dr. Koos. “We are committed to working closely with the FDA to bring this therapy to patients as quickly and safely as possible.”
We will be covering the submission and FDA’s response during our presentation at the Emerging Growth Conference 4:35 Eastern Time on September 24, 2025 https://goto.webcasts.com/starthere.jsp?ei=17...p;sti=rgbp.
https://www.globenewswire.com/news-release/20...erate.html
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 diseases,” said Dr. David Koos, Chairman and CEO of Regen BioPharma. “Receiving orphan drug designation would provide important regulatory and commercial advantages as we continue clinical development of HemaXellerate.”
Orphan drug designation is granted by the FDA to drugs and biologics intended to treat rare diseases affecting fewer than 200,000 people in the United States. If granted, the designation provides benefits such as seven years of market exclusivity upon approval, tax credits for clinical testing, and exemption from certain FDA application fees.
Aplastic anemia is characterized by the failure of the bone marrow to produce sufficient blood cells, leading to fatigue, infections, and uncontrolled bleeding. Current treatment options are limited, and many patients do not respond adequately to standard therapies.
HemaXellerate, an autologous mesenchymal stem cell product, is expected to restore hematopoietic stem cell function and reverse the effects of aplastic anemia-induced bone marrow suppression. Regen BioPharma plans to initiate Phase I clinical trials shortly.
“We believe HemaXellerate has the potential to significantly improve the lives of patients suffering from this debilitating condition,” added Dr. Koos. “We are committed to working closely with the FDA to bring this therapy to patients as quickly and safely as possible.”
We will be covering the submission and FDA’s response during our presentation at the Emerging Growth Conference 4:35 Eastern Time on September 24, 2025 https://goto.webcasts.com/starthere.jsp?ei=17...p;sti=rgbp.
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