Regen Biopharma Stock Price, News & Analysis

Regen BioPharma (OTC:RGBP) is preparing its response to FDA comments regarding their Orphan Drug Application for HemaXellerate, a novel cell-based therapy targeting aplastic anemia. The treatment, utilizing autologous mesenchymal stem cells, aims to restore hematopoietic stem cell function in patients with this rare bone marrow disorder affecting fewer than 200,000 Americans.

If granted, the orphan drug designation would provide significant benefits including seven years of market exclusivity upon approval, tax credits for clinical testing, and FDA application fee exemptions. The company plans to initiate Phase I clinical trials soon and will discuss the FDA submission during their presentation at the Emerging Growth Conference on September 24, 2025.

Regen BioPharma (OTC:RGBP) announced plans to expand the development of HemaXellerate, its cellular therapy, to treat chemotherapy-induced bone marrow suppression. The company estimates a potential market exceeding $1 billion annually in the US alone.

HemaXellerate aims to address myelosuppression by stimulating hematopoietic stem cells to enhance recovery of all three major blood cell lines simultaneously. This approach differs from current treatments that typically target single blood cell lineages. The company is preparing for a Phase I study in aplastic anemia patients, with plans to expand into chemotherapy-related trials as a second indication.

Regen BioPharma (OTC:RGBP) has provided updates on its FDA-cleared Phase 1 clinical trial for HemaXellerate, a stem cell-derived therapy initially targeting aplastic anemia. The therapy, derived from patients' fat tissue, aims to stimulate bone marrow regeneration and restore blood cell production capabilities.

The company is exploring expansion into the chemotherapy-induced bone marrow suppression market, valued at over $1 billion annually. The clinical trial, managed by a specialized CRO, is expected to complete within 12-14 months. HemaXellerate's potential applications extend beyond aplastic anemia to various hematological disorders, positioning it as a potentially transformative treatment option.

Regen BioPharma (OTC Pink: RGBP) has announced plans to seek Orphan Drug Designation for HemaXellerate, its stem cell-derived therapy for treating aplastic anemia. The company has already received FDA clearance for Phase I clinical trials of this innovative treatment, which uses cells extracted from patients' fat tissue to stimulate bone marrow regeneration.

The potential Orphan Drug Designation would provide significant benefits, including a 25% tax credit on qualified clinical testing expenses and seven years of marketing exclusivity. The company is partnering with a specialized CRO to conduct the trials, expected to complete within 12-14 months. Beyond aplastic anemia, Regen sees opportunities in the $1 billion+ chemotherapy-induced bone marrow suppression market.

Regen BioPharma (RGBP) has provided updates on its planned Phase 1 clinical trial for HemaXellerate™, a stem cell-derived therapy that received FDA clearance. The therapy aims to stimulate bone marrow regeneration, initially targeting aplastic anemia with potential expansion into chemotherapy-induced bone marrow suppression. The company has partnered with a specialized CRO to conduct the trial, which is expected to complete within 12-14 months. The targeted market for chemotherapy-induced bone marrow suppression is valued at over $1 billion annually.

Regen BioPharma, Inc. (OTC PINK: RGBP, RGBPP) will present at the Emerging Growth Conference on September 25, 2024, at 4:00 PM Eastern Time. The company, which focuses on developing cell therapies, RNA vaccines, RNA and DNA therapeutics, and small molecule drugs, invites investors, advisors, and analysts to attend this interactive online event.

CEO Dr. David Koos will lead the presentation, providing updates on fiscal and scientific goals, progress on current programs, and the timeline for the anticipated HemaXellerate clinical phase I. Attendees will have the opportunity to ask questions in real-time during the 10-minute presentation.

Interested parties can register for the event through the provided link. An archived webcast will be available on EmergingGrowth.com for those unable to attend live.

Regen BioPharma, Inc. is set to present at the Emerging Growth Conference on May 9, 2024, offering shareholders and investors insights into its Phase 1 clinical study-ready HemaXellerate and preclinical DuraCAR programs. The event aims to provide real-time interaction with the CEO, Dr. David Koos, enabling attendees to ask questions and stay updated on the company's advancements in biotechnology.