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Brainstorm Cell Therapeutics Inc. (BCLI)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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3.0800-0.0200 (-0.65%)
At close: 4:00PM EDT
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  • F
    Fmello
    SENATE LIST (Updated Oct. 21th) 38 Total sponsors
    Bullish
  • M
    Mike
    Even though the senate is at 38 cosponsors of the bill the coat tails of fellow senate members will follow. I try will be hard for a senator to go against a bill that would save lives with over 200 congressional cosponsors and 38 fellow senator cosponsors. It should pass easy.
  • F
    Fmello
    BrainStorm to Present Phase 2 Progressive MS Study Results in Oral Presentation at 37th Congress of ECTRIMS
    ir.brainstorm-cell.com
    Bullish
  • F
    Fmello
    BrainStorm to Present ALS Phase 3 Biomarker Analyses at Annual NEALS Meeting October 6th, 2021

    BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that a scientific abstract titled "CSF biomarker correlations with primary outcome in NurOwn Phase 3 clinical trial" will be presented as a scientific poster at the fully digital 2021 Northeast Amyotrophic Lateral Sclerosis Consortium® (NEALS) conference. The presentation will be delivered by James Berry, M.D. MPH, Winthrop Family Scholar in ALS Sciences, Director of the Massachusetts General Hospital (MGH) multidisciplinary ALS clinic and Chief of the Division of ALS and Motor Neuron Diseases, Boston MA. The Phase 3 trial (NCT03280056) evaluated three repeated intrathecal administrations of NurOwn® (MSC-NTF cells), each given two months apart, as a treatment for amyotrophic lateral sclerosis (ALS). The presentation will highlight CSF biomarkers that demonstrate high accuracy in predicting the primary clinical outcome using an unbiased stepwise logistic regression analysis.

    Presentation details:
    Session Date: October 6th 2021
    Presenting Time: 4:00pm – 5:00pm ET

    "We are fully committed to advance our proprietary cell therapy NurOwn® in ALS" said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We believe that making tangible progress in ALS science and clarifying the molecular signature of NurOwn's mechanism of action in ALS will be an important next step in bringing a much needed therapy to patients with ALS who have a terminal disease and have limited treatment options."

    Stacy Lindborg, EVP and Head of Global Clinical Research at Brainstorm commented, "We are excited to show the significant changes of NurOwn across a range of biomarkers spanning important domains such as neurodegeneration, neuroinflammation and neuroprotection. Furthermore, by using biomarker response and an innovative statistical model, we can predict treatment outcomes in the study with great accuracy. These objective biomarker endpoints provide more confidence as we continue researching and developing NurOwn."

    The poster will be available on the Publications page of Brainstorm's corporate website, following the presentation at the NEALS conference.
    Bullish
  • t
    thebostonangler
    I wonder if John King can bring some attention to Brainstorm's MS trials...
  • J
    Juan
    I found on Twitter that we have 37 senators. @fmello do you know if this is right? Also found this:
    Eliana Goncalves and 5 others follow
    Laura | #EndALS at IAMALS.ORG
    @lauramanhardt
    ·
    10h
    Day 80 Asking
    @US_FDA
    to approve #NurOwn and #AMX0035 for #ALS patient use now.

    @alsassociation
    Are you in?

    Can
    @BrainstormCell
    commit like
    @AmylyxPharma
    ?

    Can you help
    @janschakowsky

    @DrWoodcockFDA

    @RepAnnaEshoo

    @POTUS

    @VP

    @FDACDERDirector
    ?

    Please save ALS patients now!
  • T
    Tal
    In my opinion, Brainstorm's poster from Thursday was groundbreaking, not less. It shows that certain biomarkers can predict clinical status for ALS patients. Thus, it showed that Nurown doses have an 82.5% correlation with clinically improvement effect. THIS IS NEW KNOWLEDGE TO THE SCIENCE NEVER PROVEN BEFORE. Just to make it clear, p3 results showed statistical significance for this secondary endpoint (there was NO DIFFERENCE in any of the placebo group's biomarkers). One can only assume that if this knowledge was known prior to p3, the biomarkers would have been the trial's primary endpoint since this is an objective and scientific measurement to measure Nurown's effect (rather than the 'notorious' ALSFRS subjective measure which was effected by placebo..). This is the golden ticket for p3 approval. This is what the FDA meant for when it stated it needs "more data". When this understanding will come to all investors, stocks should fly high...
    Bullish
  • M
    Mdm
    I think at this point only event that will move this stock is positive peer review. With EAP data and new bio marker data, we should get AA or BLA. As for timeline, almost 6 months for peer review and it could take a year, then the approval could take another 6-12 months.
  • l
    lisa
    This is to clarify a response I made in an earlier post to Tal. The graphic I cited was a conflated rendition of both the poster and a direct quote from Stacy Lindborg. The direct quote is from a PR Newswire-PRF-Oct 6,4p.m cdt. The actual phrase she uses “innovative statistical model” . I am sorry for making this mistake, I am still a believer in the treatment. The point I was making is this may be a reason for what I see s a delay in peer review, having to justify the use of an innovativ statistical model. There are enough battles to fight with the FDA, doctors biologists pals investors big pharma, why add statisticians to the mix?
  • M
    Mike
    as a retired biologist, BCLI has a treatment that is solid to its core. I guess most of you are correct re poor management. maybe another large biotech might merge with Brainstorm and have management that knows what they are doing!
  • B
    Bob
    Does one get the sense that the investor community had lost faith in BCLI and, by direct association, Chaim?

    Board, it’s time to put on your big boy pants and do your job! Find a CEO that the Street believes in.
  • m
    mfglola
    "Biogen is actively engaging with regulators, the medical community, patient advocacy groups and other key stakeholders around the world to determine potential next steps" after Tofersen failure. Sounds familiar.
  • F
    Fmello
    SENATE LIST (Updated Oct. 14th) 36 Total sponsors
    Bullish
  • P
    Park
    5 month low.
    And chaim is having shabbat dinner.
    No where to be seen & nothing to.say.
  • D
    Diallo
    I'm in at 600 option contracts (60,000 possible shares) for $7.5 calls exp Jan 21 2022. The Phase 3 biomarker data looks great from the poster. At 10 cents per option on these Jan $7.5 calls as of today, I'll be buying them up over the next few weeks. This new data (and hopefully the pending medical journal publication) will be catalysts for a BLA request announcement by year end. Of course this is just my own personal justification for buying in more BCLI.
  • J
    Juan
    @tal Again I saw this tweet where they affirm amx was turn down by health Canada. I couldn't not find the original tweet that I saw back then. But I just wanted you to know I didn't make that up.
    John Salty Moreland
    If it was approved in Canada, it would be through your Neuro or clinic, I would say.
    Brainstorm in Israel has not applied for NUROWN in Canada to my knowledge.
    AMLYX applied in June for AMX0035 but supposedly/apparently turned down by health Canada right after our election. Someone said today it could be special access approved. It’s suppose to help breathing as I understand it and give up to 6 months on average life extension
    The two ingredients are on Amazon , I take one of them TUDCA, daily.
    One thing of note is Health Canada normally follows the FDA, unfortunately
  • s
    scott
    Hindsight…but why didn’t they just run another ph3 a year ago? Wouldn’t they be about in the same or better position today?
  • J
    JT
    I added more shares based upon the biomarker presentation. Not only does this increase the liklihood for approval, but these biomarkers data are going to be helpful in tailoring new future treatments for als.
  • F
    Fmello
    BrainStorm to Present Phase 2 Progressive MS Study Results in Oral Presentation at 37th Congress of ECTRIMS

    BrainStorm Cell Therapeutics Inc (BCLI). (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that a scientific abstract titled "Phase 2 Safety and Efficacy Study of Intrathecal MSC-NTF cells in Progressive Multiple Sclerosis" will be presented in an oral presentation at the fully digital 37th Congress (CACOX) of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The presentation will be delivered by Jeffrey Cohen, M.D. Director of Experimental Therapeutics at the Cleveland Clinic Mellen Center for MS.

    The presentation will feature results from a Phase 2 trial that evaluated three repeated intrathecal administrations of NurOwn® (MSC-NTF cells), each given 2 months apart, as a treatment for progressive multiple sclerosis (MS). The trial achieved the primary endpoint of safety and tolerability, and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers. Abstracts are now available online: https://ectrims2021.abstractserver.com/program/#/results.
    Bullish
  • B
    Bob
    Why isn’t Chaim asking for BCLI investors to submit questions?

    Will he finally answer queries about his bloated salary and the deflated stock price? Heads he wins and tails the investors lose.
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