HemaXellerate / Regen BioPharma - LARVOL DELTA

Regen BioPharma Prepares Response For FDA Regarding Its Orphan Drug Application for HemaXellerate (GlobeNewswire) - "The Company is confident that it will be able to satisfactorily address any comments received...The submission of the ODA marks a key milestone....Regen BioPharma plans to initiate Phase I clinical trials shortly."

New P1 trial • Orphan drug • Aplastic Anemia

Regen BioPharma, Inc. Expands Vision for Phase 1 Clinical Trial of HemaXellerate (GlobeNewswire) - "Regen BioPharma, Inc...today provided further insight into its planned Phase 1 clinical trial of HemaXellerate...While the initial focus is on treating aplastic anemia, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in a market poised for significant growth...While the company’s initial target is aplastic anemia—a rare orphan indication—it sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market valued at over $1 billion annually...Once initiated, the study is expected to reach completion within 12 to 14 months."

New P1 trial • Aplastic Anemia • Hematological Disorders

Regen BioPharma, Inc. to Discuss Plans to Move Forward with HemaXellerate into Clinical Phase 1 at the Emerging Growth Conference on April 4, 2024 (PRNewswire) - "Regen BioPharma, Inc...will be presenting at the Emerging Growth Conference on April 4, 2024...'We plan to use this time to update our shareholders on current plans and opportunities to advance our most advanced asset, HemaXellerate, into Phase 1 trials.'....Regen BioPharma, Inc. will be presenting at 4:10-4:20 Eastern time on Thursday April 4, 2024."

New P1 trial • Pipeline update • Oncology