NeuroSense Receives Positive FDA Feedback on Phase 3 Study Design for PrimeC
NeuroSense Therapeutics Ltd. (NRSN)
Company Research
Source: PR Newswire
The Type C meeting with the FDA, combined with the recent 18-month Phase 2b PARADIGM study readout, has the Company on track to commence a Phase 3 study in mid-2025PrimeC has already demonstrated a significant impact on slowing disease progression and increasing survival rates in people living with ALSCAMBRIDGE, Mass., Dec. 11, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it has concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). The purpose of the meeting was to discuss the design of a proposed Phase 3 clinical study and the plan for submission of an eventual 505(b)(2) marketing application. The Company had a productive discussion with the FDA regarding the design of the planned Phase 3 pivotal study with PrimeC, including efficacy a
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News
- NeuroSense Therapeutics files to sell 5.28M ordinary shares for holders [Seeking Alpha]Seeking Alpha
- NeuroSense Therapeutics Enters Binding Term Sheet to Advance PrimeC for ALS [Yahoo! Finance]Yahoo! Finance
- NeuroSense Therapeutics Enters Binding Term Sheet to Advance PrimeC for ALSPR Newswire
- NeuroSense Provides Business Update and Third Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- NeuroSense Provides Business Update and Third Quarter 2024 Financial ResultsPR Newswire
NRSN
Sec Filings
- 12/26/24 - Form F-3
- 12/23/24 - Form 6-K
- 12/18/24 - Form 6-K
- NRSN's page on the SEC website