Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Dr. Alvarez comments about the Sickle Cell study at U of Washington and the Pancreatic Study are misleading. Aphexda is THE DRUG being studied in both which he failed to mention. In fact, he refers to Aphexda as one of two drugs being studied. He said "the company has two Phase 2 drugs, one for sickle cell disease [SCD], working in collaboration with Washington University in St. Louis, and AGI-134 medication for treating Solid Tumors. Additionally, BLRX is researching Phase 1 with a drug to treat Pancreatic Cancer in partnership with Columbia University"
agree. Aphexda has been added to several Formularies of very large insurance plans. I think we'll hear just how good the roll out (very good imo) has been and may be an early sales projection.
Aphexda has been added to several Drug Formularies for large health insurance plans like the National Association of Letter Carriers Health Insurance and today it was added to Kaiser Permanente's Formulary Health Plan (the largest not for profit Health plan in the US).
in 🙂
It looks like 5.5M shares traded at the TASE close when the price spiked.
#AACRPan23 talk by Dr. Gulam Manji @columbiacancer on CheMoMETPANC 👉🏽 gemcitabine plus nab-paclitaxel + motixafortide (CXCR4 antagonist) + cemiplimib in advanced #PancreaticCancer. Responses observed in both primary & metastatic sites, with 64% partial responses & 27% stable… pic.twitter.com/IWQfGPQxEg
— Anirban Maitra (@Aiims1742) September 28, 2023
From Dr. Manji's presentation: pancreas and liver tumors shrinking
Proud to report the results of the pilot phase of our investigator-initiated clinical trial @AACR Pancreas.
— Gulam Abbas Manji (@DrGManji) September 29, 2023
I started the preclinical study in KPC mice in @KenOliveLab and then work continued in my lab. Randomized phase 2 to activate soon at 5 sites! pic.twitter.com/qpOfUKdXPF
From the PDAC abstract: Notice how the Biomarkers for Cancer begin to decline after the immune system starts to ramp up
Proud to be a part of this exciting Phase 1 trial of chemo/immuno therapy in #pdac @columbiacancer led by my former fellow/current colleague @DrGManji. Started with a preclinical trial in our lab, now moving to randomized phase 2. Presented @aacr pdac2023. #justkeepswimming pic.twitter.com/fXVv87ptYD
— KenOliveLab (@KenOliveLab) September 28, 2023
my guess is Monday before the market opens
agree, I bought more too. holding a ton now, too much, but couldn't resist. ??
incredible
keep in mind that this estimate is for Multiple Melanoma only. there are many other therapies requiring Stem Cell harvesting that fit perfectly in BLRX's model.
I've managed to find a few 'flying under the radar' stocks over the years and I think this is another one. I got on NNOX when it was at $7 and OTLK at just over $1. The parallels between BLRX and OTLK are remarkable but BLRX has more potential imo
Hey Mello, I have the same questions. I came across this stock while researching OTLK which has an almost identical story. For starters, the PDUFA date is when the FDA will approve or not a drug/therapy. BLRX's Phase 3 study was a huge success plus they have a promising pipeline but the PPS has not moved. I think this has to do with Wall Street not paying attention, shorts are probably controlling the PPS which is easy to do with low volume stocks and the number of small offerings (dilution) the company had over the last 3-4 years has pushed the stock price down. It's still hard to believe that BLRX has a market cap of less than $100M with this much potential. An analyst with WainWright has a target price of $19 so I guess we'll see what happens on 9/9/23.
market cap under $100M? doesn't make sense to me based on the news
nice bounce with volume near the close. Choice Choi on twitter says NNOX leased a suite in Fort Lauderdale for their US demo location
It's hard to see why approval will not be a slam dunk given that this therapy is already the Standard Of Care which was confirmed in the PIII trial representing SUPERIORITY to Lucentis.
Nice movement this week, hope it's due to leakage...
Phase III trial of NurOwn shows evidence of mechanism of action in amyotrophic lateral sclerosis.- BrainStorm Cell Therapeutics
BrainStorm Cell Therapeutics announced the presentation of new biomarker analyses supporting the therapeutic benefit of NurOwn in amyotrophic lateral sclerosis (ALS) at the ongoing 5th Annual ALS ONE Research Symposium.
The presentation was delivered by Dr. Stacy Lindborg, Chief Development Officer at Brainstorm, and entitled, "The Relationship between CSF Biomarkers and Efficacy of Treatment with NurOwn (MSC-NTF cells)."
NurOwn's Phase III trial is a strong outlier compared to other late-stage ALS trials due to the inclusion of participants with more advanced disease. The average ALSFRS-R score in NurOwn's Phase III trial was 31, 5 points lower than the registrational trial for the most recently FDA-approved therapy. The inclusion of more advanced participants impacts the assessment of all clinical endpoints based on the ALSFRS-R, as a result of the inability to measure ongoing clinical decline with scale in these participants (i.e., a floor effect). To draw valid conclusions from clinical endpoint data collected in the trial, the floor effect must be addressed. As previously announced, a NurOwn treatment effect was observed in participants in a pre-specified subgroup with less advanced disease (ALSFRS-R baseline score of at least 35) across two endpoints: the primary endpoint (clinical responder analysis) and a key secondary endpoint (average change from baseline to the end of the trial). The difference between NurOwn and placebo for this key secondary endpoint was nominally statistically significant (p=0.050).
An analysis was performed to evaluate the effects of NurOwn and placebo on cerebrospinal fluid (CSF) biomarkers across pathways important to ALS of neuroinflammation, neurodegeneration and neuroprotection. Additional goals were to understand the role that baseline ALSFRS-R values plays on biomarker trajectories and to understand the predictive power of biomarkers on clinical outcomes. As observed in earlier trials, NurOwn was shown to decrease biomarkers associated with neuroinflammation and neurodegeneration, and increase neuroprotective biomarkers over 20 weeks, demonstrating its multifaceted mechanism of action. New analyses looked at the trajectory of biomarkers for the subgroups of participants with baseline ALSFRS-R scores >25 and less than or equal to 25, those most likely to be impacted by the floor effect of the scale. Decreases in neuroinflammatory and neurodegenerative markers and increases in neuroprotective markers in NurOwn treated participants compared to placebo were observed in both subgroups. These results indicate that NurOwn had similar biological effects on ALS participants regardless of the level of disease progression at baseline. Further statistical modeling pre-specified prior to unblinding of the data identified three biomarkers that were predictive of clinical outcomes: baseline LAP, baseline neurofilament light (NfL) and mean change in Galectin-1. These biomarkers relate to neuroinflammatory, neurodegenerative, and neuroprotective pathways, respectively.
Hard to imagine BCLI not being a slam dunk for approval even without the outstanding Biomarker data. I'm leaning more and more to BLA acceptance, Accelerated Review with NO Advisor Panel meeting.
More and more analyst are predicting approval. I like the $20+ PPS Target after BLA accepted and approval.
FDA's approval of AMLX's drug is very positive for BCLI IMO. Their data (clinical effect and BioMarker) is much weaker than BCLI and Advocacy for BCLI is Very Strong.
Seeking Alpha: Excellent Summary on BCLI
https://seekingalpha.com/article/4535982-brainstorm-cell-therapeutics-upcoming-bla-in-als
My guess is the BLA was filed around the first of September. If I'm correct we'll hear from the FDA by the end of October. FDA acceptance and Priority Review are a slam dunk. It would be surprising for the FDA not to require an Advisory Panel meeting however given the fact that NurOwn provides STATISTICALLY SIGNIFICANT meaningful outcomes as measured by the ALSFRS-R scale in a very important subset of patients (those with early less severe disease) pre-defined in the PIII study, it's not outside the realm of possibilities. BCLI has been able to link positive outcomes with their critical BioMarker data to reinforce NurOwn's mechanism of action which points directly to why it works best in those with early, less severe disease. All IMO
AMLX paves the way for BCLI: 10+ Bagger - Wall Street is asleep on this one.
FDA's Panel nod to AMLX for ALS means FDA acceptance of BCLI's BLA a certainty imo.
The transcript of BCLI's BLA announcement: https://seekingalpha.com/article/4534421-brainstorm-cell-therapeutics-inc-s-bcli-ceo-chaim-lebovits-on-q2-2022-results-earnings-call
Correcting the statistical model for a key Pre-specified Secondary Endpoint resulted in a statistically significant improvement for patients in this sub-group.
This is huge but here's the kicker. The FDA has been putting more emphasis on how ALS treatments affect key Biomarkers. NurOwn improved 3 very important markers in patients who responded favorably. **AND** BCLI will publish this Biomarker data in a PEER REVIEWED JOURNAL in the very near future.
With a Market Cap of $138M, BCLI compared to AMLX Market Cap nearing $2B, it's a 10+ Bagger.
AMLX FDA 's Positive vote bodes very well for BCLI
Will be interesting to see how the committee interprets this but there's a BIG difference between AMLX and BCLI. AMLX needs to convince the FDA that their new model to evaluate efficacy is solid even though their clinical trial was not designed for it and there's not historical data to support doing so.
BCLI's issue is much different. The vendor in charge of analytical analysis of the trial data made a mistake. Correcting this error resulted in A STATISTICALLY SIGNIFICANT outcome in a KEY SECONDARY ENDPOINT which WAS PRE-SPECIFIED in the trial study designed (no smoke and mirrors). AND many of the BIOMARKERS the FDA believes are important to measure disease showed SIGNIFICANT improvement.
Definitely not Apples to Apples, more like Apples to Dollar bills IMO
FDA has 60 days to accept or decline BLA submission. I believe we'll know the outcome by the end of October.
BioSpace: NurOwn A Study in the complexity of ALS trials
https://www.biospace.com/article/nurown-a-study-in-the-complexity-of-als-trials-/
Elon's Letter = TWTR Bankruptcy?
How long before investor lawsuits and SEC action? Filing false or misleading info to the SEC is a BIG DEAL..
In addition to the foregoing, Twitter is in breach of the Merger Agreement because the Merger Agreement appears to contain materially inaccurate representations. Specifically, in the Merger Agreement, Twitter represented that no documents that Twitter filed with the U.S. Securities and Exchange Commission since January 1, 2022, included any “untrue statement of a material fact” (Section 4.6(a)). Twitter has repeatedly made statements in such filings regarding the portion of its mDAUs that are false or spam, including statements that: “We have performed an internal review of a sample of accounts and estimate that the average of false or spam accounts during the first quarter of 2022 represented fewer than 5% of our mDAU during the quarter,” and “After we determine an account is spam, malicious automation, or fake, we stop counting it in our mDAU, or other related metrics.” Mr. Musk relied on this representation in the Merger Agreement (and Twitter’s numerous public statements regarding false and spam accounts in its publicly filed SEC documents) when agreeing to enter into the Merger Agreement. Mr. Musk has the right to seek rescission of the Merger Agreement in the event these material representations are determined to be false.
Elon's Letter: BIG TROUBLE for Twitter. False/Inaccurate Info in their SEC filings will be met with shareholder lawsuits and possibly bankruptcy for Twitter IMO.
In addition to the foregoing, Twitter is in breach of the Merger Agreement because the Merger Agreement appears to contain materially inaccurate representations. Specifically, in the Merger Agreement, Twitter represented that no documents that Twitter filed with the U.S. Securities and Exchange Commission since January 1, 2022, included any “untrue statement of a material fact” (Section 4.6(a)). Twitter has repeatedly made statements in such filings regarding the portion of its mDAUs that are false or spam, including statements that: “We have performed an internal review of a sample of accounts and estimate that the average of false or spam accounts during the first quarter of 2022 represented fewer than 5% of our mDAU during the quarter,” and “After we determine an account is spam, malicious automation, or fake, we stop counting it in our mDAU, or other related metrics.” Mr. Musk relied on this representation in the Merger Agreement (and Twitter’s numerous public statements regarding false and spam accounts in its publicly filed SEC documents) when agreeing to enter into the Merger Agreement. Mr. Musk has the right to seek rescission of the Merger Agreement in the event these material representations are determined to be false.
Gavin Newsom joins THE TRUTH, let’s see if he can handle it ??
The discount on warrants is going away imo
Trump now legally committed to posting on TRUTHSOCIAL. So much for the Shorts misinformation ??
Been on TRUTHSOCIAL since the early beta rollout and it is only getting better. I listened to Devin's podcast detailing TS's future and it's very exciting. It will not happen overnight but will be a huge success if they get it done IMO
From TS: Bot Sentinel estimates Twitter fake accounts to be 10-15%
Lots of smoke around Twitter's BOT ISSUE. Engagement on twitter falls well below their number of Users compared to TRUTHSOCIAL.
DJT has over 2,500,000 followers in just two weeks on TRUTHSOCIAL. ??