NeuroSense Therapeutics Ltd (NRSN)

[FooBarAndGrill]

re: "only 1-to-3 cases out of any 100,000 peeps."

W R O N G

Roughly 1 in every 400 people will develop ALS in their lifetime. And evidence shows that ALS is much more common in older people.
https://www.als.net/news/1-in-400-how-many-people-will-get-als/

[Monksdream]

Dead money

[FooBarAndGrill]

Zoom Registration 7:30 AM Central:
https://us06web.zoom.us/webinar/register/9217016389894/WN_Oak2BJKyR_a6pMnL6h038g#/registration

[runncoach]

Most likely yes but the company needs the cash to fund the P3 and this is a great opportunity with this volume. Fingers crossed for positive results

[BooDog]

Just filed this morning... Form EFFECT - Notice of Effectiveness
December 05 2023 - 12:15AM
Edgar (US Regulatory)

Selling into the news????? Likely imo.

https://ih.advfn.com/stock-market/NASDAQ/neurosense-therapeutics-NRSN/stock-news/92726447/form-effect-notice-of-effectiveness

[stockforce]

In this October's conference call, the company was asked the possibility of getting FDA approval right after Phase 2b results.
Q: Amylyx ($AMLX) received FDA approval for their combination therapy after a single phase two study (for ALS). So do you believe you'll be able to do the same for Prime C?

A: It's really entirely based on the readout of the phase 2B study. We're going to be in close connection with regulators and if the results are compelling we'll discuss this pathway forward with them (FDA), but ultimately it will be dependent on the readout.

Q: Can you predict how how early could Prime C be on the market?

A: Due to the dynamic regulatory environment and based on these decisions by the FDA for Amylyx and Biogen's therapies over the last 12 months, if we have outstanding data from the phase 2B study, it could be after we have data from this study we could move forward and have Regulators approve Prime C.

Watch the video starting at 18'43"

https://www.youtube.com/watch?v=ZLL_QdiepMo

[Invest-in-America]

NRSN: However, here's the BIG PROBLEM with any stock out of ISRAEL of late:
https://nypost.com/2023/12/04/business/hamas-may-have-reaped-windfall-betting-against-israeli-stocks-reportinvestors-linked-to-hamas-may-have-reaped-massive-financial-windfalls-from-the-oct-7-terrorist-attacks-according-to-a-pair-of-promin/

PS: And ALS is an extremely RARE disorder --- i.e., only 1-to-3 cases out of any 100,000 peeps.

[Invest-in-America]

NRSN: Will NRSN's clever 'Lou Gehrig's Disease' drug hit a proverbial 'HOME RUN' tomorrow (all puns intended)??? Or, sadly 'STRIKE OUT' on Wall Street????
https://www.prnewswire.com/news-releases/neurosense-to-report-phase-2b-als-topline-primary-safety-and-tolerability--secondary-clinical-efficacy-endpoints-on-december-5-2023-302005044.html

[subslover]

Thank you!

[stockforce]

NeuroSense to Report Phase 2b ALS Topline Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints on December 5, 2023
PR Newswire
Data to be announced in a premarket press release followed by a conference call at 8:30 am ET

[stockforce]

"In early December, we look forward to reporting topline clinical results from our Phase 2b ALS study. We believe that positive results would offer substantial hope to people living with ALS and would put PrimeC well on its path to a pivotal Phase 3 for regulatory approval," stated NeuroSense's CEO, Alon Ben-Noon. In November 2023, NeuroSense completed the 6-month double-blind segment of PARADIGM, a placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC, 96% of participants who completed the double-blind segment of the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension. All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC.

https://neurosense.investorroom.com/2023-11-28-NeuroSense-Announces-Third-Quarter-2023-Financial-Results-and-Provides-Business-Update

This part is huge: "All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC." They could convince FDA to go directly for approval.

[stockforce]

NeuroSense Announces Third Quarter 2023 Financial Results and Provides Business Update

https://neurosense.investorroom.com/2023-11-28-NeuroSense-Announces-Third-Quarter-2023-Financial-Results-and-Provides-Business-Update

Topline clinical secondary efficacy results and primary safety endpoints from Phase 2b ALS trial (PARADIGM) expected in early December 2023
Patients who completed the 18-month PARADIGM trial, including the 6-month double-blind study plus the 12-month open label extension, have requested to continue treatment with PrimeC
First patient in Phase 2 Alzheimer's disease study expected to be enrolled December 2023
Cash runway beyond topline clinical study readouts, into Q2 2024
CAMBRIDGE, Mass., Nov. 28, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today reported its financial results for the nine months ended September 30, 2023 and provided a business update.

"In early December, we look forward to reporting topline clinical results from our Phase 2b ALS study. Additional data, including the biomarker results from our collaboration with Biogen and primary biomarker endpoints are expected within the first half of 2024. We believe that positive results would offer substantial hope to people living with ALS and would put PrimeC well on its path to a pivotal Phase 3 for regulatory approval," stated NeuroSense's CEO, Alon Ben-Noon. "With a cash runway extending towards the end of Q2 2024, we believe we are well positioned, upon a positive read out from the study, to advance our discussions with potential strategic partners."

Continue Reading
NeuroSense_Therapeutics_Logo
View File Download File
NeuroSense_Therapeutics_Logo
Business Update

Phase 2b Amyotrophic Lateral Sclerosis (ALS) PARADIGM Trial Completed Double-Blind Segment

In November 2023, NeuroSense completed the 6-month double-blind segment of PARADIGM, a placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC, which is designed to maximize the synergistic effect between the compounds in its combination drug. 96% of participants who completed the double-blind segment of the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension. All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC. NeuroSense supplies the drug to the participants through an Investigator Initiated Trial (IIT) and will continue to provide PrimeC to any participant who completes the trial and requests to stay on the Company's investigational ALS medication.

PARADIGM's secondary clinical endpoints which are expected to be reported in December 2023 include: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Slow Vital Capacity (SVC), and overall survival to demonstrate an attenuation in disease progression. NeuroSense also expects to report primary safety and tolerability results from the double-blind segment of the trial in December 2023.

U.S. FDA Confirmed CMC Strategy for PrimeC Ahead of Pivotal Phase 3 for Commercial Readiness

NeuroSense recently concluded a successful Type D meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of ALS. FDA Type D meetings are focused on a narrow set of issues at key decision points to provide timely feedback critical to move a drug development program forward. The purpose of NeuroSense's meeting with the FDA was to discuss PrimeC's chemistry, manufacturing, and controls (CMC) development plans in advance of an expected Phase 3 pivotal study and potential subsequent marketing approval. The FDA agreed with NeuroSense's proposed CMC development plan, setting the stage for a smooth progression with the production PrimeC for a Phase 3 and subsequent commercialization.

Non-Sponsored Study Demonstrated PrimeC's Outstanding Effect on ALS Survival

At the Ichida Stem Cell Lab at University of Southern California, PrimeC was shown to significantly increase the survival rate of induced motor neurons in an in vitro study utilizing induced pluripotent stem cells (iPSCs) generated from people living with ALS. In another independent study carried out by Dr. Ichida in an innovative iPSC model, PrimeC performed among the best in improving motor neuron survival when compared to two FDA approved ALS drugs as well as several other ALS drugs in development. Together, these results reinforce previous findings on PrimeC's efficacy and mechanism of action.

Phase 2 Alzheimer's Disease (AD) Trial Under Preparation, First Patient Enrolled Expected in Q4 2023

NeuroSense published data from a biomarker study which revealed elevated levels of novel biomarker TDP-43 in AD as compared to healthy controls in the first quarter of 2023. These results demonstrate the therapeutic potential of NeuroSense's combination drug platform for AD. Currently, NeuroSense is preparing a Phase 2 double-blind proof-of-concept clinical study in AD. Regulatory submissions and site readiness have been ongoing during Q3 2023 and the first patient enrolled is expected in December 2023.

Patents Granted in Europe, Japan, and Israel for PrimeC Valid Through 2038

Patents have been granted in Europe, Japan, and Israel for a key patent relating to "Compositions comprising an anti-inflammatory drug and a dicer activator for use in treatment of neuronal diseases." These patents address NeuroSense's unique fixed-dose combination of ciprofloxacin and celecoxib, two FDA approved drugs that are the active ingredients in PrimeC.

SME Status Received from European Medicines Agency & NeuroSense Opens EU Office

The European Medicines Agency's (EMA) Small and Medium-Sized Enterprise (SME) status offers NeuroSense regulatory guidance and engagement in dialogue with the EMA. The Company plans to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS study of PrimeC. As Europe is a key market, in addition to the U.S., NeuroSense opened an office in Ulm, Germany to lead its regulatory dialogue with the EMA and clinical operations during the planned Phase 3 study.

Financial Summary

Research and development expenses for the nine months ended September 30, 2023 increased to $5.6 million compared to $4.9 million for the nine months ended September 30, 2022. This increase was primarily attributable to an increase in expenses to subcontractors and consultants as well as salaries and social benefits as a result of the commencement of a Phase 2b ALS clinical study in the second quarter of 2022, which were partially offset by a decrease in share-based compensation expenses. NeuroSense expects research and development expenses will remain steady through 2023.
General and administrative expenses for the nine months ended September 30, 2023 decreased to $4.4 million compared to $5.3 million for the nine months ended September 30, 2022. This decrease was primarily attributable to a decrease in directors and officers insurance expenses and share-based compensation, which were partially offset primarily by an increase in payroll and related expenses. NeuroSense expects that general and administrative expenses will remain steady through 2023.
Operating expenses for the nine months ended September 30, 2023 were $10.02 million compared to $10.17 million for the nine months ended September 30, 2022 due to the reasons described above.
As of September 30, 2023, NeuroSense had cash of approximately $4.8 million.

In October 2023, the Company terminated its previously established "at-the-market" ("ATM") equity offering program.

A summary of NeuroSense's unaudited consolidated financial results is included in the tables below.

[stockforce]

At 13 minutes in the webinar, the CEO said: the results obtained from our phase 2b study will dictate our regulatory strategy as there is a chance we could file directly based on these results"! WOW! if the results can be this good, $NRSN will run past $10 overnight! This is huge. Great confidence from the CEO.

[stockforce]

NeuroSense Webinar with Emerging Growth Conference - October 4, 2023

https://www.youtube.com/watch?v=ZLL_QdiepMo

Besides their highly expected great results from ALS Phase 2b trial to be released in December, they also have started the Phase 2 trial for Alzheimer's disease with very positive results from the phase 1 trial. As the CEO said on November 7, 2023, "In December, NeuroSense will unvail the clinical Top-line results of the Paradigm study (phase 2b trial), marking a major turning point in the fight against ALS. We are committed to sharing all results from this groundbreaking clinical trial with the ALS community." This company will be huge.

[stockforce]

As the CEO and Co-Founder of NeuroSense Therapeutics, I lead this unique Biotech startup that is dedicated to finding a cure for ALS and other neurodegenerative diseases.

I am privileged to work with a team of experts and pioneers in ALS research, who have developed an innovative and revolutionary drug candidate that has shown promising results in preclinical and clinical trials. Our mission is to accelerate the delivery of this therapy to the people who suffer from this devastating condition, and to explore its potential for other CNS disorders. I am passionate about making a positive impact in the world through science and innovation.

Alon Ben-Noon

[stockforce]

PrimeC boosts survival of motor neurons derived from ALS patients
Potential oral therapy in Phase 2b clinical trial with results likely this year

https://alsnewstoday.com/news/primec-boosts-survival-als-patient-derived-motor-neurons/#:~:text=PrimeC%20combines%20the%20antibiotic%20ciprofloxacin,NEALS)%20annual%20meeting%20in%20Florida.

PrimeC, NeuroSense Therapeutics‘ investigational, fixed-dose combination therapy for amyotrophic lateral sclerosis (ALS), significantly boosted the survival of patient-derived motor neurons to levels similar to healthy controls in a lab study.

The independent study was led by Justin Ichida, PhD, a professor of stem cell biology and regenerative medicine at the University of Southern California (USC).

“Dr. Ichida has been described as being beyond the cutting edge in his field and we are honored that he and his lab chose to evaluate PrimeC in this non-sponsored study,” Alon Ben Noon, founder and CEO of NeuroSense, said in a company press release.

PrimeC combines the antibiotic ciprofloxacin with anti-inflammatory celecoxib
Findings were presented by Shiran Zimri, PhD, NeuroSense’s vice-president of research and development, at the recent Northeast Amyotrophic Lateral Sclerosis (NEALS) annual meeting in Florida.

“These results further bolster our confidence that PrimeC may offer a much-needed therapy for this debilitating disease,” Noon said.

PrimeC is an oral, fixed-dose combination of two approved compounds with well-established safety profiles: the antibiotic ciprofloxacin and the anti-inflammatory celecoxib.

Together, the medications are expected to prevent ALS progression by targeting inflammation and other mechanisms that damage motor neurons, the nerve cells in the brain and spinal cord that coordinate movement by sending commands to muscle cells.

Ichida and his team at USC’s Eli and Edythe Broad CIRM Center for Regenerative Medicine and Stem Cell Research examined the efficacy of PrimeC in patient-derived motor neurons.

These cells were generated from blood cells using a kind of cellular programming. First, the scientists collected blood cells from ALS patients and healthy people. Then, through a series of biochemical manipulations, the blood cells were reprogrammed into induced pluripotent stem cells, or iPSCs, which are lab-made stem cells able to grow into other types of cells.

Because the iPSCs retain the genetic code of the person that the blood cells were collected from, they enable the creation of nerve cells that recapitulate the same features of diseased motor neurons. iPCS also provide an almost unlimited source of patient-derived motor neurons, which can be used for large screenings of potential therapies.

“At our lab, we screen thousands of compounds in search of one that may be effective in ALS, and we were very impressed by the data resulting from our iPCS in vitro study of PrimeC,” Ichida said. “We chose to evaluate PrimeC based on the growing body of clinical, pre-clinical, and biomarker data on its efficacy in ALS.”

PrimeC protected motor neurons more effectively than its components alone
In a previous study, Ichida found PrimeC to be among the best at improving motor neuron survival in a list that included multiple approved and experimental ALS therapies, NeuroSense reported, adding that PrimeC outperformed Relyvrio (sodium phenylbutyrate and taurursodiol) and Radicava (edaravone) in that study’s model.

In the current study, researchers compared survival rates of ALS motor neurons with PrimeC versus each of its components. They also tested each of those treatments against motor neurons derived from healthy individuals.

Data showed that, while both ciprofloxacin and celecoxib led to significantly better survival rates than no treatment, the combination therapy was better than either drug alone at improving cell survival.

Notably, ALS motor neurons treated with PrimeC had survival rates similar to those seen in healthy motor neurons, NeuroSense reported.

“These findings present a new opportunity to potentially screen super responder patients using iPSCs, a non-invasive method which only requires a blood draw from the patient. Using this screening model may result in higher efficacy in people living with ALS who are most likely to benefit from PrimeC,” Zimri said.

In a Phase 2a clinical trial (NCT04165850) that concluded in 2021, an early formulation of PrimeC showed a potential to safely slow overall disease progression and lung function decline compared with an historical group of patients.

A new, extended-release formulation of PrimeC is being investigated in a Phase 2b clinical trial, called PARADIGM (NCT05357950). There, 69 adults were randomly assigned to the experimental medicine or a placebo, given twice daily for six months alongside standard ALS medications. Top-line trial findings are expected in the coming months.

[stockforce]

NeuroSense’s CMC earn FDA OK ahead of PrimeC Phase 3 trial Results from Phase 2b PARADIGM trial expected next month

Patricia Inácio, PhD avatar
by Patricia Inácio, PhD | November 16, 2023


https://alsnewstoday.com/news/fda-oks-neurosenses-cmc-primec-ahead-phase-3-trial/


The U.S. Food and Drug Administration (FDA) has signed off on the chemistry, manufacturing, and controls (CMC) clinical development plan for NeuroSense Therapeutics‘ lead candidate for amyotrophic lateral sclerosis (ALS) ahead of a planned Phase 3 study.


The Phase 3 trial of PrimeC is due to start in 2024 pending positive results from the company’s ongoing PARADIGM Phase 2b clinical trial (NCT05357950), whose results are expected in December. CMC refers to the manufacturing practices and product specifications that must be followed and met to ensure product safety and consistency between batches.

“This confirmation from the FDA of our CMC strategy for a future pivotal Phase 3 clinical trial and commercial launch of PrimeC in the treatment of ALS marks a critical milestone in our drug development program,” Alon Ben-Noon, CEO of NeuroSense, said in a company press release. “It sets the stage for a smooth transition, particularly as we anticipate clinical efficacy top-line results (secondary endpoints) from our Phase 2b trial very soon.”


PrimeC is an oral, fixed-dose combination of ciprofloxacin, an antibiotic, and celecoxib, an anti-inflammatory. Both are approved in the U.S. for other indications. The compound’s combined action would block key mechanisms in ALS to slow disease progression.

RECOMMENDED READING
An illustration for
October 2, 2023 News by Andrea Lobo, PhD
PrimeC, potential ALS therapy, earns patents in Europe, Japan, Israel
What is PARADIGM trial assessing?

An initial formulation of PrimeC was deemed safe and well tolerated, in a Phase 2a clinical trial (NCT04165850) with 15 ALS patients. After treatment, patients saw a slower decline in their functional and respiratory abilities over a historical group of untreated patients. Key ALS blood biomarkers, particularly TDP-43, also were reduced.

PARADIGM is assessing the safety and effectiveness of a longer-acting formulation of PrimeC, which would release the medications over time, requiring less frequent dosing.


A total of 69 ALS patients from Canada, Italy, and Israel were randomly assigned to a placebo or PrimeC for six months, while continuing with their standard ALS treatments. PrimeC was given at a total daily dose of 1,496 mg, taken as two tablets twice daily.

The trial will also measure PrimeC’s impact on key ALS blood biomarkers, TDP-43 and prostaglandin J2. Changes in functional disability, assessed by the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as lung health, quality of life, and survival will also be assessed.

After completing six months of treatment in the trial’s randomized part, most patients (96%) joined an open label extension, where they are receiving PrimeC for a year.

The company plans to announce safety results and data from the trial’s secondary measures in December. Biomarker analyses, including those conducted in collaboration with Roche, are due in the first half of 2024.

PrimeC has received orphan drug status in the U.S. and the European Union. The designation is meant to accelerate the development and regulatory review of rare disease therapies.

[stockforce]

NeuroSense Therapeutics to Present at Upcoming U.S. and European ALS Conferences NeuroSense Therapeutics

09 Nov, 2023, 09:00 ET

https://www.prnewswire.com/news-releases/neurosense-therapeutics-to-present-at-upcoming-us-and-european-als-conferences-301983397.html


- Last patient completed the double-blind segment of PARADIGM, a Phase 2b ALS Trial

- Clinical efficacy top-line results from PARADIGM expected in December 2023

CAMBRIDGE, Mass., Nov. 9, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced scientific presentations at three upcoming conferences.

Neuroscience 2023

Mr. Nitai Kerem, NeuroSense's Scientific Project Manager, will present a poster on NeuroSense's latest biomarker data at Neuroscience 2023, the Society of Neuroscience's annual conference. This is the largest U.S. Neuroscience conference, bringing together scientists and physicians devoted to understanding the brain and the nervous system. The conference will be held in Washington D.C. on November 11th-15th, 2023.

ALS ONE's 6th Annual ALS Research Symposium

Dr. Shiran Zimri, VP of R&D at NeuroSense, will present the Company's latest clinical updates and findings in her talk titled "Shifting the Paradigm - A Biomarker Driven Approach for Studying Amyotrophic Lateral Sclerosis (ALS) Therapy Activity" at ALS ONE's 6th Annual ALS Research Symposium, to be held virtually on November 16th-17th, and 20th 2023. In addition to NeuroSense being a sponsor of this year's conference, this marks the fourth year NeuroSense will present at ALS ONE's symposium.

With a focus on the Company's Phase 2b PARADIGM PrimeC study, Dr. Zimri will present key elements of PrimeC's development program. The last patient has completed the double-blind segment of PARADIGM, with clinical efficacy results (secondary endpoints) expected in December 2023.

The 34th International Symposium on ALS/MND

Dr. Shiran Zimri and Dr. Ferenc Tracik, NeuroSense's Chief Medical Officer, will present a poster at the 34th International Symposium on ALS/MND, which brings together leading ALS and motor neuron disease (MND) experts, European patient advocacy groups, and ALS foundations, on December 6th-9th, 2023 in Basel, Switzerland.

"We believe NeuroSense's highly innovative approach of using biomarkers as a primary efficacy endpoint in our Phase 2b PARADIGM study will further elucidate the biological activity of PrimeC and help us to better understand the effect on people living with ALS," said Dr. Zimri. "We are excited to soon begin sharing the initial results of the double-blind segment of our Phase 2b trial to determine our drug's impact on efficacy."

About PARADIGM

NeuroSense's Phase 2b PARADIGM trial evaluating PrimeC's efficacy, as well as safety and tolerability, in people living with ALS. The study is randomized 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability.

[stockforce]

Alon Ben-Noon. CEO

Join us in spreading Hope for those affected by ALS!

In December, NeuroSense will unveil the clinical Top-line results of the Paradigm study, marking a major turning point in the fight against ALS. We're committed to sharing all results from this groundbreaking clinical trial with the ALS community.

Please help us reach as many as possible - share this message with your loved ones. Together, we can make a difference. 🩵 #ALS #HopeForACure

[stockforce]

https://renmark-drupal.s3.amazonaws.com/vndr/neurosense-therapeutics-ltd/2023-03-21-11-00-00/index.html

[rakp]

Aw1416 if I may ask, how do you see the future of this company. My little knowledge about the subject tells me this is important and serious stuff but when I compare this to the interest it may not be so.

Would like to have your opinion.
Thanks

[Awl416]

NeuroSense Receives U.S. FDA Confirmation of CMC Strategy for PrimeC in Preparation for Pivotal Phase 3 in ALS and Commercial Readiness

[Monksdream]

NRSN new 52 week low

[Awl416]

Damn

[rakp]

Could it be that the company's performance is affected by the GAZA call-up of some it its scientists/workers?

[Monksdream]

NRSN new 52 week low

[Monksdream]

NRSN new 52 week low

[Monksdream]

NRSN new 52 week low

[Monksdream]

NRSN new 52 week low

[Monksdream]

NRSN new 52 week low

[Monksdream]

NRSN new 52 week low

[McMagyar]

So the Biogen relationship..

Biogen needs something for als..
Probably just conceding or selling this to them .. makes sense.. they would have been a very competitive force against Neuro..so capitulation makes sense..

I would have a third party double check their data tests..

No really.. I would be sending the samples to a third party and PAYING for verification and NOT solely relying on bioscam..

[McMagyar]

Anavex has a miracle drug call Blarcamesine
Early on they made the mistake of opening the door to Biogen with als co research with Biogen..
Wayne state did a study the drug worked great for als..

Nothing .. nothing..

Blarcamesine still isn’t approved ( 10 years later) while Biogen has ad drugs approved that are dangerous and do nothing.

Anavex hasn’t wandered any deeper into als.. and anavex stock has been undervalued for almost the entire time they have had a Biogen relationship.

Personally I see Biogen as I see Pfizer

Neither gives a crap about human life or health..

[rakp]

Why is doing business with Biogen so bad?
What experience/example can you relate to?
I was interested in getting some shares but reading your posts it may not be a good idea.
I am a bit confused here, maybe I don't understand the issue.

[McMagyar]

They sold the good news..$8.xxx.xxx
Thought it might be a little better ..
Oh well..
Good luck with bioscam

[McMagyar]

If the relationship goes well they might do something like
Short your stock so you lose your investor base and ability to reside money
Than make you a chump change offer because you are out of money..

Would never do business with amoral people..
Good bye Nrsn

[McMagyar]

Just saw it’s an engagement with bioscam..
Who would willingly do business with Biogen?
Too bad

[McMagyar]

3rd confirmation of good news

[subslover]

THANK YOU!!!
https://ih.advfn.com/stock-market/NASDAQ/neurosense-therapeutics-NRSN/stock-news/90178420/neurosense-receives-approval-in-germany-to-enroll

[tw0122]

Some news on watch again

[crudeoil24]

Probaby time for another 424B3 shelf placement!

[crudeoil24]

NeuroSense Therapeutics Sees Positive Trial Results for TDP-43 Alzheimer's Treatment
9:03 am ET January 19, 2023 (Dow Jones) Print

By Chris Wack


NeuroSense Therapeutics Ltd. said it saw positive final results from a biomarker study conducted to evaluate the potential of NeuroSense's combination platform therapy for the treatment of Alzheimer's disease.

The company said preliminary results from the study showed that TDP-43, a novel biomarker, was elevated in Alzheimer's disease patients compared with a healthy control group.

Based on these preliminary results, NeuroSense said it expanded the study with a larger healthy control group to further validate the results.

NeuroSense's platform combination therapy technology has already shown a statistically significant reduction of TDP-43 in a Phase 2a clinical trial biomarker study in another neurodegenerative disease, amyotrophic lateral sclerosis, and is now being evaluated in a Phase 2b ALS double-blind clinical trial.

The company plans to start a Phase 2 double-blind proof-of-concept study in Alzheimer's disease in the first half of 2023.

NRSN

[harry crumb]

Boom

[lowercaseBACON]

I’m out. Nice 60%! TY

[subslover]

Thanks so much, buddy. Wishing you all the very best to come

[frankyahoo]

No worries. Good luck with all your trades.
$NRSN

[subslover]

Sorry, bro, many others will pop. Biotechs heating hup after a long slump.

[frankyahoo]

Saw this. Unfortunately, I clipped it yesterday. Left a bunch on the table. This is not unusual lol. You're welcome. $NSRN.

[subslover]

Good morning Franky buddy. It's payday baby!
NeuroSense Therapeutics Reports Positive Preliminary Results from Novel Alzheimer's Biomarker Study
Biomarkers show the potential of NeuroSense's combination drug CogniC to treat Alzheimer's disease
CogniC is expected to advance into clinical trials in 2023
CAMBRIDGE, Mass., June 30, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced results from a biomarker study conducted to evaluate the potential of CogniC, NeuroSense's combination drug for the treatment of Alzheimer's disease (AD).


NeuroSense's biomarker study identified several biomarkers associated with AD, which indicate CogniC's mechanism of action may be effective in targeting the pathways involved in the disease, such as miRNA dysregulation, lysosomal dysfunction, and impaired autophagy. Additionally, hallmarks of AD were detected, such as increased levels of amyloid-ß (Aß) and intracellular aggregates of tau protein among the panel of biomarkers evaluated.

Preliminary results revealed high levels of TDP-43 in people who suffer from AD, when compared to the healthy control group. These findings provide additional support for TDP-43 pathology as an integral part of AD, reinforcing the growing body of evidence in AD research regarding the role of TDP-43 in neurodegenerative pathologies. TDP-43 has been found in up to 57% of AD cases and aggregates of TDP-43 have been shown to be cytotoxic both in vitro and in vivo. [1] NeuroSense's platform combination therapy technology, the basis of CogniC, has already shown to impact TDP-43 in a Phase IIa clinical trial biomarker study in another neurodegenerative disease, amyotrophic lateral sclerosis (ALS).

"Having identified these promising biomarkers, which have the potential to be modulated by CogniC, we are now preparing to carry out a clinical proof-of-concept study in conjunction with a leading AD clinic. The study is expected to commence in 2023," stated NeuroSense CEO, Alon Ben-Noon.

NeuroSense is conducting its AD biomarker study via utilization of Neuron-Derived Exosomes (NDE), a cutting-edge technology which allows one to observe key alterations in biomarkers found in the central nervous system in a non-invasive manner via collection of blood samples. Following further analysis, NeuroSense expects to share more detailed results on additional novel biomarkers that were evaluated in this study through scientific conferences and peer-reviewed publications.

About TDP-43

Transactive response DNA binding protein of 43 kDa (TDP-43) is involved in regulation of gene expression. AD patients with TDP-43 pathology have increased severity of cognitive impairment compared to those without TDP-43 pathology. Additionally, the strongest genetic risk factor for AD, apolipoprotein E4 (APOE4), is associated with increased frequency of TDP-43 pathology.[1]

About Alzheimer's Disease

Alzheimer's disease (AD) is a brain disorder that slowly destroys memory and thinking skills. AD is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer's disease accounts for 60-80% of dementia cases. The global AD treatment market is expected to grow to $5 billion in 2022.

About CogniC

CogniC is a combination drug for the treatment of Alzheimer's disease and is based on NeuroSense's combina

[lowercaseBACON]

NRSN is running hot on the RSI for good reason. NRSN is creating novel treatments. It's a new path forward in an otherwise, sort of maxed approach. It appears NRSN's contribution stabilizes the disease rather than continuing downward with standards of (current) care, if I understand this correctly. These results (and anytime they'll drop the alz and parkinsons biomarker data) are VERY significant for the neurological field in general. It appears NRSN's contribution is statistically significant and everyone loves that! Stabilizing! It's going to be bumpy but up we will go! They slammed the heck out of this today but there is absolutely no way, NRSN stays below $5-$6 soon. These findings are absolutely amazing in nature. The stock continues to trend and the shorts that love biotechs (especially) will be blown away once this thing really takes off. Those days are upon us now, and it'll only get louder and more exciting in here! They've got almost $14 million in cash and a pipeline that is PRODUCING! Tough to find these days; especially in such an important arena. They're improving terrible, debilitating diseases right before our eyes. Terrific findings reported and will continue! Best to all!