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

Maxim Group initiated coverage of NeuroSense Therapeutics with a rating of Buy and set a new price target of $7.00

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

The preparations for the regulatory submission for early commercialization in Canada follows the positive Phase 2b trial results which show PrimeC reduces ALS disease progression by 36% and improves survival rates by 43% Company plans to seek approval in additional countriesCAMBRIDGE, Mass., Oct. 9, 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 initiated the regulatory process to seek early commercialization approval for PrimeC under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This submission is based

CAMBRIDGE, Mass., Oct. 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the acceptance of two abstracts focusing on the company's lead drug candidate, PrimeC, for the treatment of Amyotrophic Lateral Sclerosis (ALS). These abstracts will be presented at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis (NEALS) Consortium Meeting, taking place October 21 to October 24 in Clearwater, Florida. The abstracts will highlight groundbreaking data from NeuroSense's Phase 2b PARADIGM study. The first abstract, presenting clinical out

The Company's intellectual property now covers the combination, formulation, and method of use of PrimeCPatent protection extends through 2042, adding four additional years to PrimeC's IP umbrellaCAMBRIDGE, Mass., Sept. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the issuance of a pivotal patent by the United States Patent and Trademark Office (USPTO). The newly granted patent, entitled "Compositions comprising Ciprofloxacin and Celecoxib" (US Patent No. US 12,097,185), relates to the novel formulation of PrimeC, NeuroSense's l

CAMBRIDGE, Mass., Sept. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd.  (NASDAQ:NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that it has received notice from The Nasdaq Stock Market LLC ("Nasdaq") informing the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Rule") for continued listing.     To regain compliance with the Rule, the Company's ordinary shares were required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, which was achieved on September 20, 2024. Therefore, the Nasdaq Listing Qualifica

CAMBRIDGE, Mass., Aug. 30, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense" or the "Company"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that it has received a notification letter from the Nasdaq Stock Market LLC ("Nasdaq"). The letter notifies the Company that it is not in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market, since the closing bid price for the Company's ordinary shares listed on the Nasdaq was below USD $1.00 for 30 consecutive trading days. Nasdaq Listing Rule 5550(a)(2) requires

CAMBRIDGE, Mass., Aug. 7, 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 certain investors to purchase $600,000 of ordinary shares and warrants in a private placement. In connection with the offering, NeuroSense agreed to sell an aggregate of 800,000 ordinary shares and warrants to purchase an aggregate of 800,000 ordinary shares, at a combined purchase price of $0.75 per share and accompanying warrant, representing a purchase price of 10% above the closing pricing of NeuroSense's ordinary sh

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

https://patentcenter.uspto.gov/applications/18047289/ifw/docs

NeuroSense Therapeutics (NASDAQ:NRSN) reported quarterly losses of $(0.35) per share which missed the analyst consensus estimate of $(0.20) by 75 percent. This is a 6.06 percent decrease over losses of $(0.33) per share from the same period last year.

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PrimeC slowed disease progression by 43% (p=0.02) in pre-specified high-risk ALS patientsConsistent data across subgroups underscore the potential of PrimeC to redefine the ALS treatment paradigmCAMBRIDGE, Mass., May 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, announces new analyses from its Phase 2b PARADIGM clinical trial, demonstrated a statistically significant slowing of disease progression in high-risk ALS patients treated with PrimeC by 43% (p=0.02) as compared to placebo in the pre-specified per protocol (PP) population analysis after 6 months of treatment.  The slowing

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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