NeuroSense in Compliance with all Nasdaq Listing RequirementsCAMBRIDGE, Mass., Jan. 6, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Company received formal written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Nasdaq's stockholders' equity requirement ("Equity Requirement") set forth in Nasdaq Listing Rule 5550(b)(1). The Company's Ordinary Shares will continue to be listed and trade on The Nasdaq Capital Market under the symbol "NRSN". This confirmation follows the Compan

Binding Term Sheet with a leading global pharmaceutical company includes a substantial upfront payment and funding for the Phase 3 studyAdditionally, milestone payments and double-digit royalties on annual net salesThe transaction is subject to finalization of a definitive agreement, anticipated in Q1 2025CAMBRIDGE, Mass., Dec. 23, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announced today that it has entered into a binding term sheet with a leading global pharmaceutical company to advance the development and commercialization of PrimeC, its prop

CAMBRIDGE, Mass., Dec. 18, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today provided business update with corporate highlights to date and third quarter financial results. "The completion of the 18-month Phase 2b PARADIGM study was a major milestone for NeuroSense. The results highlight PrimeC's potential impact on slowing disease progression and survival benefits in people living with ALS. Furthermore, the positive feedback from a Type C meeting with the FDA on the pivotal study design has the Company on track to commence a Phase 3 study in mid

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

In participants who received PrimeC from the start of the 18-month study compared to those initially on placebo before transitioning to PrimeC, disease progression was slowed by 33% (p=0.007), demonstrated in a 58% improvement in survival rates Consistent data across subgroups underscore the potential of PrimeC to redefine the standard of care in the treatment of ALSCAMBRIDGE, Mass., Dec. 4, 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 today statistically significant positive results from the 18-month data analysis of the PAR

CAMBRIDGE, Mass., Dec. 2, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the entry into a definitive agreement with a single investor and with NeuroSense's Chief Executive Officer, Mr. Alon Ben-Noon, to purchase an aggregate of $5,000,000 of ordinary shares (or ordinary share equivalents) and warrants in a private placement, subject to certain closing conditions. In connection with the offering, NeuroSense agreed to sell an aggregate of 4,000,000 ordinary shares (or ordinary share equivalents) and 8,000,000 warrants to purchase an ag

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

Dossier submission planned for Q2 2025; regulatory decision expected by Q1 2026 Estimated potential market opportunity: peak of $100M to $150M in annual revenueCompany aims to expand approval efforts to additional global marketsCAMBRIDGE, Mass., Oct. 15, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, provided a further update on its plans to file for early commercialization approval for PrimeC under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This submission is based on promising results from the Company's Phase 2b ALS PARADI

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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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

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