Hopstem Receives U.S. FDA IND Clearance and Fast Track designations for hNPC01 in Hemorrhagic Stroke and Traumatic Brain Injury-Expanding Clinical Development Across Three Major Brain Injury IndicationsHOUSTON, July 29, 2026 (GLOBE NEWSWIRE) -- Hopstem Biotechnology announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application and Fast Track designations for hNPC01, an allogeneic induced pluripotent stem cell (iPSC)-derived forebrain neural progenitor cell therapy, for the treatment of chronic motor dysfunction due to Hemorrhagic Stroke (ICH) and Traumatic Brain Injury (TBI).
Hopstem hNPC01 Cell Injection Earns FDA RMAT Designation for Chronic Stroke TherapyHOUSTON, June 03, 2026 (GLOBE NEWSWIRE) -- Hopstem Biotechnology, a clinical-stage biotech specializing in iPSC-derived cell therapeutics for neurological diseases, has secured the first Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for its proprietary human forebrain neural progenitor cell injection, hNPC01. The candidate has displayed potential for treating persistent motor dysfunction due to basal ganglia ischemic stroke in phase I clinical study[1].
FDA Granted Hopstem’s hNPC01 for Chronic Ischemic Stroke Approval to Enter Phase 2/3 Adaptive Pivotal Clinical Trial with Bridging StudyHOUSTON, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Hopstem Biotechnology Inc. (hereinafter referred to as "Hopstem"), a company dedicated to the development of induced pluripotent stem cell (iPSC)-derived allogeneic neural cell therapy products, announced today that it has successfully convened an End-of-Phase 1 (EOP1) meeting with the U.S. Food and Drug Administration (FDA) recently. The two parties reached a high level of consensus on the accelerated clinical development pathway of the core product, hNPC01 Injection, for the treatment of chronic motor dysfunction due to ischemic stroke.
