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 Indications
HOUSTON, July 29, 2026 (GLOBE NEWSWIRE) -- Hopstem Biotechnology announced that the U.S. Food and Drug Administration
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HOUSTON, 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).
The IND represents the world’s first FDA-authorized clinical programs of an iPSC-derived forebrain neural progenitor cell therapy for motor impairment after ICH and TBI. Chronic motor impairment after hemorrhagic stroke and TBI often leads to lifelong hemiparesis, impaired mobility and loss of independence. Millions of survivors in the U.S. and worldwide live with persistent disability, and there are currently no approved disease-modifying therapies capable of regenerating damaged neural tissue to deliver sustained motor function recovery. This substantial unmet medical need underpins the FDA’s decision to award Fast Track status to hNPC01 across these two critical neurological injury indications.
Survivors of hemorrhagic stroke and traumatic brain injury frequently develop persistent chronic motor dysfunction. Epidemiological data indicate:
Globally, around 3.4 million new hemorrhagic stroke cases occur annually. Among ICH survivors worldwide, 50%–60% experience significant chronic motor deficits one year after onset, predominantly hemiparesis, spasticity and gait dysfunction. In the United States, roughly 70,000–95,000 new hemorrhagic strokes are recorded each year. Spontaneous neurological recovery mostly occurs within the first six months post-insult, with minimal natural improvement observed in the chronic phase.
Worldwide, approximately 69 million people sustain a TBI each year. In the U.S., an estimated 2.8 million TBIs occur annually; roughly 15%–20% are moderate-to-severe. Clinical cohorts demonstrate that nearly 30% of moderate-to-severe TBI survivors struggle with sustained walking impairment two years post-injury, and approximately 25% endure long-term upper and lower extremity motor control deficits.
Collectively, these two conditions affect tens of millions of patients globally, with millions living with chronic motor disability across the United States.
“Receiving IND clearance and Fast Track Designations for both hemorrhagic stroke and traumatic brain injury represents a major regulatory milestone for hNPC01 and underscores the urgent clinical demand for regenerative treatments for chronic brain injury survivors,” said Dr. Jing Fan, CEO of Hopstem Biotechnology. “We are encouraged by FDA’s recognition of hNPC01’s potential to address a devastating gap in patient care. We will leverage this expedited pathway to advance our clinical programs efficiently, working closely with regulators to bring this novel cell therapy to patients who currently have no effective restorative treatment options.”
Preclinical and early clinical evidence demonstrates hNPC01’s capacity to integrate into host neural networks and drive durable motor function improvement. Hopstem continues advancing its global clinical development strategy for hNPC01 across ischemic stroke, hemorrhagic stroke and traumatic brain injury, building on positive safety and efficacy signals observed in earlier trials.
Clinical Evidence from Stroke Supports Expansion into TBI
The encouraging safety and efficacy findings from Hopstem’s Phase I clinical studies of hNPC01 in patients with chronic motor dysfunction due to ischemic stroke include:
No product-related adverse events other than manageable immune responses was observed in participants for up to 2.5 years. No treatment-related neurological deterioration has been reported.
Key clinical findings include:
- At 12 months, patients in the target subgroup achieved a mean improvement of 16 points on the Fugl-Meyer Motor Scale (FMMS), with nearly 80% achieving clinically significant improvement (≥10-point gain).
- At 18 months, more than 92% of patients achieved clinically meaningful motor recovery, while 54% demonstrated at least a one-level improvement on the modified Rankin Scale (mRS).
- Two-year follow-up data indicate durable clinical benefit, with functional improvement maintained through a sustained efficacy plateau.
About hNPC01
hNPC01 is an allogeneic human forebrain neural progenitor cell product differentiated from clinical-grade iPSCs using Hopstem’s proprietary second-generation differentiation platform. Following intracranial delivery, cells mature into forebrain-type neurons and glia, support neural repair and circuit reformation to reverse persistent motor deficits after severe brain injury.
The ischemic stroke program has received multiple U.S. FDA regulatory recognitions, including Fast Track Designation, Regenerative Medicine Advanced Therapy (RMAT) designation.
About Hopstem Therapeutics
Hopstem Therapeutics is a pioneering clinical-stage biotech focused on developing scalable, off-the-shelf iPSC-derived neural cell therapies for neurological injuries and neurodegenerative diseases. The company aims to transform treatment paradigms from symptomatic management to neural regeneration, delivering transformative therapeutics for underserved patient populations globally.
Contact:
Tel: +1-732-822-1963
Email: BD@hopstem.com
References
[1] U.S. FDA. Traumatic Brain Injury: What to Know About Symptoms, Diagnosis, and Treatment.
[2] SanBio Co., Ltd. Notice Regarding the Subcommittee Review Results on Partial Change Approval for AKUUGO® Suspension for Intracranial Implantation.
[3] SanBio Co., Ltd. Notice Concerning Chuikyo Approval of Proposed NHI Price for AKUUGO®.
[4] Xiao H, et al. Forebrain neural progenitors effectively integrate into host brain circuits and improve neural function after ischemic stroke. Nature Communications. 2025; 16:5132.
[5] Hopstem’s iPSC-derived neural progenitor cell injection earns FDA RMAT designation for chronic stroke
[6] FDA Granted Hopstem’s hNPC01 for Chronic Ischemic Stroke Approval to Enter Phase 2/3 Adaptive Pivotal Clinical Trial with Bridging Study
