The planned submission follows alignment with Health Canada on the NDS pathway and is supported by additional PARADIGM data, including a survival benefit and consistent effects across PrimeC's multi-pathway biomarker program

CAMBRIDGE, Mass., July 22, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced it intends to proceed with the filing of a New Drug Submission (NDS) to Health Canada (the "Agency") for PrimeC for the treatment of amyotrophic lateral sclerosis (ALS), following a constructive Pre-New Drug Submission ("Pre-NDS") meeting with the Agency. NeuroSense expects to complete and file the submission in the coming months.

The recent Pre-NDS meeting was held following the generation of substantial additional evidence from the Phase 2b PARADIGM clinical program. NeuroSense presented Health Canada with a comprehensive update to its proposed NDS package, including achievement of the study's prespecified primary TDP-43 biomarker endpoint (p=0.0421), long-term survival (14.9-month median survival benefit, HR 0.35 and p=0.0037), external natural history analyses, and additional mechanistic and translational data generated since the Company's initial regulatory interaction. The meeting also included an expert clinical perspective from a leading Canadian ALS specialist, as well as additional supportive analyses that will form part of the planned NDS package, further strengthening the growing body of evidence supporting PrimeC's potential in ALS.

NeuroSense plans to continue to work with Health Canada as it prepares the NDS filing, and looks forward to providing further updates as the submission advances.