NeuroSense Therapeutics (NRSN) said Monday it is scheduled for a type C meeting with the US Food and Drug Administration Nov. 6 to discuss the design of a phase 3 clinical trial for its lead drug candidate PrimeC for the potential treatment of amyotrophic lateral sclerosis.
The company plans to provide an update on meeting results after receiving the meeting minutes, which are expected roughly one month after the event, it said.
NeuroSense also said it plans to submit its regulatory dossier to Health Canada in Q2, with a regulatory decision expected by Q1 2026.
ALS is an incurable neurodegenerative disease that causes complete paralysis and death within two to five years from diagnosis, the company said. NeuroSense said its PrimeC has shown 'promising' results in clinical trials, including a statistically significant reduction in disease progression clinical and biological markers.
NeuroSense shares were up 3.2% in recent Monday trading.
Price: 1.31, Change: +0.04, Percent Change: +3.15
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。