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SEOUL - CorestemChemon Inc. (KOSDAQ:166480), a prominent player in the Biotechnology industry despite not being profitable over the last twelve months according to InvestingPro data, presented findings from its Phase 3 ALSummit trial for Neuronata-R (lenzumestrocel), an autologous stem cell therapy for amyotrophic lateral sclerosis (ALS), at the PACTALS 2025 congress in Melbourne.
While the overall trial did not meet its primary and secondary endpoints, a subgroup analysis showed statistically significant benefits in patients with slower disease progression. At 12 months, these patients receiving Neuronata-R demonstrated higher functional ratings (ALSFRS-R score of 31.2 versus 26.4 in placebo), better combined assessment of function and survival scores, and improved respiratory function compared to placebo.
The company also reported biomarker data showing sustained reductions in neurofilament light chain and MCP-1, which it claims indicates a neuroprotective effect of the treatment.
Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that has been administered to over 400 commercial patients and 190 clinical trial participants, according to the company’s press release.
CorestemChemon plans to request a Type-C meeting with the U.S. Food and Drug Administration in Q4 2025 to discuss the dataset and potentially submit a Biologics License Application within 2026, pursuing an accelerated approval pathway. InvestingPro analysis reveals the company is quickly burning through cash, with short-term obligations exceeding liquid assets - a common scenario for biotech companies in late-stage development.
The therapy holds Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency. The company completed its Phase 2 trial in 2014 and its Phase 3 trial in 2024. Investors should note that InvestingPro data shows the stock has faced significant price volatility, with notable declines over the past year - typical for biotech companies awaiting major regulatory decisions. InvestingPro subscribers have access to 12 additional key insights about CorestemChemon’s financial health and market position.
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