European Medicines Agency Grants NeuroSense SME Status, Offers Regulatory Guidance And Engagement In Dialogue With EMA
Portfolio Pulse from Benzinga Newsdesk
NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) has been granted the Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA), which offers significant benefits leading up to and following drug regulatory approval. The company has opened an EU Office and plans to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS study of PrimeC. The EMA has already granted PrimeC Orphan Drug Status for the treatment of ALS. Topline results from its Phase 2b study are expected at the end of 2023.
September 20, 2023 | 1:09 pm
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NeuroSense Therapeutics has been granted SME status by the EMA, which will provide regulatory and financial benefits. This could potentially accelerate the approval process for its ALS treatment, PrimeC.
The SME status granted by the EMA provides regulatory guidance and financial benefits, which could potentially accelerate the drug approval process for NeuroSense's ALS treatment, PrimeC. This could lead to a positive impact on the company's stock in the short term.
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