Eyeing FDA talks, CorestemChemon highlights ALS data

South Korean biotech CorestemChemon (Kosdaq: 166480) has shared Phase III ALSummit trial findings for its autologous stem cell therapy Neuronata-R (lenzumestrocel) at the PACTALS 2025 congress in Melbourne.

The study did not meet primary and secondary endpoints overall, but a subgroup of patients with slower disease progression showed meaningful benefit. Improvements were seen in function, survival measures and respiratory capacity, alongside biomarker reductions suggesting neuroprotection.

The company plans a Type-C meeting with the American medicines regulator this year, followed by a Biologics License Application in 2026, pursuing an accelerated approval pathway similar to Biogen’s (Nasdaq: BIIB) tofersen.