| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | October 4, 2024 |
| Accession Number: | 0001213900-24-083478 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 1/7/2022 | $7.00 | Buy | Maxim Group |
Maxim Group initiated coverage of NeuroSense Therapeutics with a rating of Buy and set a new price target of $7.00
Top-Line Results from 6-month double-blind Phase 2b PARADIGM trial with NeuroSense's lead drug candidate for ALS, PrimeC, include: PrimeC achieved primary safety and tolerability endpoints with a safety and tolerability profile comparable to placeboMeaningful slowing of disease progression: 29% difference (P=0.12) in favor of ALSFRS-R outcome for patients treated with PrimeC vs placeboSlow Vital Capacity: observed a positive trend in favor of patients treated with PrimeC compared to placeboNeurofilament biomarker results from Biogen collaboration expected in January 2024Primary biomarker endpoints and exploratory biomarkers from this trial, expected in H1 2024Company to host webcast conferen
Data to be announced in a premarket press release followed by a conference call at 8:30 am ET CAMBRIDGE, Mass., Dec. 4, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a company developing treatments for neurodegenerative diseases, today announced it will report new data from the randomized, placebo-controlled, double-blind segment of its ongoing Phase 2b amyotrophic lateral sclerosis (ALS) trial (PARADIGM) of its lead drug candidate PrimeC. The data will include primary safety and tolerability endpoints as well as secondary clinical efficacy outcome measures: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and Slow Vital Capacity (S
CAMBRIDGE, Mass., Dec. 1, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced its financial results for the quarter ended September 30, 2022 and provided a business update. "During and immediately following the end of the third quarter, NeuroSense achieved multiple milestones, including FDA acceptance of our IND and approval from the Italian Medicines Agency allowing us to commence patient enrollment in the U.S. and Europe for our Phase 2b ALS study, which we expect to begin in the coming weeks. With over $8.4 million in cash and short-term deposits on our balance sheet at the e
In the study, complication-free survival revealed a 57% difference in favor of PrimeC over placebo after 12 months of treatment in the Intent to Treat (ITT) population and demonstrated an outcome of 73% (p=0.02) difference in favor of PrimeC over placebo after 12 months of treatment in the pre-defined Per Protocol Population (PP). NeuroSense intends to submit these 12-month results to regulatory agencies, including the FDA, to discuss PrimeC's path forward in the short term.Previously, NeuroSense reported that PrimeC significantly slowed disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo. The Per-Protocol analysis revealed even greater benefits, with
CAMBRIDGE, Mass., Nov. 21, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, is pleased to announce its participation in the 2024 International Symposium on ALS/MND, to be held December 6-8, 2024, in Montreal, Canada. During the event, NeuroSense will present the latest findings from its Phase 2b PARADIGM trial of PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS). Key Presentations at the Symposium: Prof. Merit Cudkowicz, Chair of Neurology at Massachusetts General Hospital, Director of the Sean M. Healey & AMG Center for ALS, and t
Meeting discussion to focus on finalizing Phase 3 study design and NDA readiness, ensuring a clear regulatory path for submission based on trial successParallel preparations in Canada: NeuroSense plans to submit its dossier in Q2 2025, with a regulatory decision on commercialization expected by Q1 2026CAMBRIDGE, Mass., Oct. 28, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it is scheduled for a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a p
Groundbreaking PARADIGM Trial Offers New Hope for ALS Treatment CAMBRIDGE, Mass., Oct. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced transformative findings from its PARADIGM clinical trial of PrimeC. These results illuminate a new frontier in the treatment of ALS (Amyotrophic Lateral Sclerosis), a disease long considered untreatable at its core. The trial demonstrating the significant impact of PrimeC on the regulation of microRNAs (miRNAs), which play a key role in ALS progression, providing compelling evidence of the drug's po
Novel Vaccine Company Expands Leadership Team and Establishes US Presence SpyBiotech, a British biotechnology company with a novel vaccine platform technology that can target infectious diseases, cancer, and chronic diseases, has appointed Mark Leuchtenberger as its Chief Executive Officer (CEO). He also joins the Board of Directors. Sumi Biswas, the company's co-founder, remains President and a Director and becomes Chief Scientific Officer (CSO). With the addition of Leuchtenberger, SpyBiotech establishes its presence in the United States with an office in Cambridge, Massachusetts. Mark Leuchtenberger recently served as Executive Chairman for Aleta Biotherapeutics and previously as CEO o
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