Galectin Therapeutics Inc (GALT) News

Sorry, your DD just doesn't cut it. Any statistician would prove your exaggerations are a distortion of reality.

More data dredging, the equivalent of painting targets around already existing bullet holes.

Any statistician with any expertise in life sciences and DB controlled studies will recognise this as a disgraceful and invalid attempt to make a silk purse out of a sow’s ear.

Clearly nothing has changed since the days of fraud during PRWP era:

https://www.thestreet.com/investing/stocks/biotech-stock-mailbag-aspenbio-10741455

NORCROSS, Ga., February 18, 2025 (GLOBE NEWSWIRE) – Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today announced additional results showing a statistically significant reduction in new varices in per-protocol patients (completers) enrolled in the U.S. from the NAVIGATE trial for belapectin in patients with Metabolic Dysfunction-Associated SteatoHepatitis (MASH) cirrhosis and portal hypertension.

The NAVIGATE trial top-line results showed that while the incidence of varices at 18 months was 43.2% lower in patients treated with belapectin 2 mg vs placebo, the composite endpoint did not reach statistical significance in the intent-to-treat population (N=355). However, in the completer population of 287 patients (revised), the incidence of varices was reduced by 49.3% in patients treated with belapectin 2 mg vs placebo (nominal p-value = 0.04 (revised)).


Following the favorable trend observed in the completers, the Company further analyzed the two thirds of the completer patients in the NAVIGATE trial enrolled in the U.S. (n=186). The incidence of varices in this population was significantly reduced by 68.1% (p=0.02) in patients treated with belapectin 2 mg (4 out of 60) vs placebo (13 out of 62) in the U.S. While all three cohorts of patients in the U.S. had a higher percentage use of GLP-1 and statins than the rest of the world, the belapectin cohorts performed much better than placebo in the U.S.

Joel Lewis, Chief Executive Officer at Galectin Therapeutics commented: “With the prevalence of MASH cirrhosis and clinically significant portal hypertension in the U.S. now estimated in Hepatology at around 3 million adults, the need for new treatments that can prevent disease progression is more urgent than we had anticipated. The significant reduction of 68% we see in incidence of new varices in completer patients in the U.S. from the NAVIGATE trial underscores belapectin’s potential as a treatment for MASH cirrhosis and portal hypertension. We are continuing to analyze the data from the trial, including from the approximately 50 patients who completed 36-months of therapy. We look forward to sharing additional clinical updates as data becomes available in the first quarter of 2025.”

The Company will determine next steps for belapectin development with potential partners in conjunction with the completion of the ongoing analyses.


1Younossi ZM, de Avila L, Racila A, et al. Prevalence and predictors of cirrhosis and portal hypertension in the United States. Hepatology. 2025 Jan 29. doi: 10.1097/HEP.0000000000001243.

Man I'm sorry.  Wish you good health 

No doubt for futility. As it has no discernible clinical effect in actual controlled trials, it’s unlikely to be for toxicity.

I am a patient of the Navigate trial, and it has been stopped.

Maybe he worked for Dr. Falsie in the past.

bullshit. it does not mean total efficacy. Give credit where it is due is what science is all about. This is what studies are for... to find what works for who and how much. You miss the whole point of trials and studies. You would not make a very good investigator throwing out good bad and ulgy data out the window. This is how you fine tune your future research. Oh let's ignore that area where there were good benefits! Hello. Get a grip dude.

sunspotter is clueless. This person follows too many stocks and doesn't know what they are talking about. Look at the latest MASH-TAG conference where good news is coming out from the independent key opinion leaders. Look at their activity on social media, it's all positive for GALT from the true experts. This drug has repeatable results in preventing varices.

That’s bullshit. Read the links I posted in my earlier post.

Claiming efficacy for a drug that failed its primary endpoint is a conman’s trick.

Wrong. Data is data and giving credit where credit is due is real science. All pharma's cite such achievements along with those that don't regardless of achieving the primary end point.

Dr. Jamil should know that once it is established that the primary endpoint has not been reached, it is widely recognised that it is not valid statistically to declare secondary endpoints and other sub-analyses as having reached statistical significance.

It’s a (not very) sophisticated form of data dredging:

“ Secondary endpoints are typically analyzed after the primary endpoint results are known: They support and complement the primary findings but cannot override the results of the primary endpoint analysis.
If a trial fails to meet its primary endpoint, positive secondary endpoint results are insufficient to consider it successful.”

https://atlantiaclinicaltrials.com/blog/research-development/what-are-endpoints-in-clinical-trials#:~:text=If%20a%20trial%20fails%20to%20meet%20its%20primary,endpoint%20results%20are%20insufficient%20to%20consider%20it%20successful.

See also: https://www.sciencedirect.com/science/article/abs/pii/S0197245697000755

https://www.fda.gov/files/drugs/published/Multiple-Endpoints-in-Clinical-Trials-Guidance-for-Industry.pdf

In the pre-specified per-protocol population, belapectin showed a statistically significant reduction (p-value < 0.05) in development of esophageal varices in 2mg/kg cohort compared to placebo
While there was a favorable trend for incidence of varices in the primary end point intent-to-treat population, belapectin did not achieve statistical significance


Dr. Khurram Jamil, Chief Medical Officer at Galectin Therapeutics, stated, “While we had hoped that the NAVIGATE trial would meet its composite primary endpoint, we are highly encouraged by trends we have seen at only 18 months of treatment in the ITT population and by the statistically significant 48.9% reduction in new varices noted in the per-protocol population with belapectin 2 mg. All enrolled subjects transitioned into a 36-month treatment period, with approximately 50 subjects completing the full 36 months to date. We are still analyzing the extensive data from the trial and anticipate providing multiple clinical updates from the subjects completing 36-month therapy, as well as additional biomarker data in Q1 2025.”
Belapectin was overall well tolerated with no safety signals; incidence of adverse events and serious adverse events were comparable across the three cohorts
Additional data to be presented in early 2025

Results were damn good. Much better than doing nothing. So I do believe this will warrant at a minimum the "Right To Try" as studies continue from the trending up to significance at 36 months.

Correct, I have read this happening many times over the past 30 years, but then again maybe it's all just a conspiracy theory! LMAO
Nothing wrong being a short based on fundamentals. Lying though doesn't cut it and there are plenty of them in the past few years. All grads from the Sykes School for Idiots. Earning the tuition fee brings out the panic and stress for such "students".

can you explain in detail how they are ineffective. Thanks

Your quote does not refute or cancel out the conclusion from Dr. Chalasani, who is looking at all the data in great detail (more than what we have access to). His conclusion of reproducible benefit is a strong statement for significant value of belapectin in cirrhosis.

Not sure why you bring up Jim. His only involvement in recent years is being a large shareholder and he's not involved with managing the company in any way; he is not even on the board anymore.

Actually this quote sums up the whole situation perfectly:

“ While there was a favorable trend for incidence of varices in the primary end point intent-to-treat population, belapectin did not achieve statistical significance”

And not only do I understand pharmaceutical research extremely well, I don’t feel the need to make excuses for serial cheats and liars like Jim Czirr.

This quote sums it up succinctly. Dr. Chalasani has an impeccable reputation, a respected authority in the field, and he would not make up something that he doesn't believe and have evidence for.

"Belapectin clearly is offering a reproducible benefit and should be continued in clinical development as there is a significant unmet need for patients with MASH cirrhosis.” - Dr. Naga Chalasani

Dr. Chalasani is considered an authority in the fields of Nonalcoholic Fatty Liver Disease (NAFLD) and Drug Induced Liver Injury (DILI), two highly significant public health problems. His research has been continuously funded by the National Institutes of Health since 1999. He is currently the PI for three U01 awards and an R01 award from the National Institutes of Health. He published over 300 original papers, 3 Practice Guidelines, 47 book chapters/review articles, 31 editorials/commentaries, 16 symposium proceedings, and more than 500 abstracts. He has co-edited a textbook with Prof. Gyongyi Szabo titled ‘Alcoholic & Nonalcoholic Fatty Liver Disease – Bench to bedside’ (Springer 2015). He is the lead author for the AASLD Practice Guideline on the Diagnosis and Management of Nonalcoholic Fatty Liver Disease.

Some people posting here do not understand pharmacology.

A less effective higher dose happens sometimes especially in immunology (keep in mind that galectins are native immune system proteins that modulate macrophage polarization to affect fibrotic pathways). Examples of other common drugs exhibiting this behavior include immunomodulators, beta-blockers, and hormonal therapies, among others.

Why Higher Doses Can Appear Less Effective
In some studies, high doses of a drug can paradoxically look less effective. This can happen due to several factors:

- Reduced Receptor Turnover: If the target proteins (Galectin-3) are already occupied, additional drug might not only fail to add benefit but could also alter how the body handles or clears the complex, changing the dynamic equilibrium.

- Changes in Drug Clearance or Metabolism: Higher levels of belapectin might trigger regulatory mechanisms in the liver or kidneys that clear the drug more rapidly, resulting in reduced steady-state concentrations at the target site over time.

- Potential Off-Target Effects: Excess drug can bind weakly to non-target proteins or set off other responses, sometimes counteracting the positive effects seen at lower doses.

Hope you listened to your more cautious advice to yourself.

I rather think you missed the point. It’s not that higher doses of GALT’s drug are toxic, it’s that they are ineffective.

Given the purported mechanism, that almost certainly means lower doses are too, and that the implication that the lower dose worked is merely an artefact.

I rather like it here and have posted on this MB for over a decade. I’ll hang around whether you like it or not.

Insider director buy a day ago, above the price I paid days ago.

I like it, I love it, I want some more of it.

Shorts have no shares left to borrow and the cost to borrow is 98%
Holy shit Sherlock, never seen that before. Ever heard of a bear trap?
The guy funding GALT is no Dummy, and experienced and super rich $$$$$$.

⌛️⌛️⌛️ ⌛️ ⌛️

https://ih.advfn.com/stock-market/NASDAQ/galectin-therapeutics-GALT/stock-news/95177233/form-4-statement-of-changes-in-beneficial-owners

Indeed:

Superior article and well written by Zerohedge. It not only explains and identifies the efficacies, but exposes the real world greed factors that are slowing down progress by the research that should be getting the attention and funding. So looking forward to the new bosses at our health agencies that seem to be raring to go in cleaning up the corruption within the FDA etc and Big Pharma. Thanks for posting this article.

#DHMO is deadly in higher doses as well, but life can not exist with out it.

https://www.DHMO.org

There is no logic or basis in that BS you posted. Shorts are drowning with no shares left to borrow. They dug their own grave.

So move along little short doggie.

Superior article and well writtien by Zerohedge. It not only explains and identifies the efficacies but exposes the real world greed factors that are slowing down progress by the research that should be getting the attention and funding. So looking forward to the new bosses at our health agencies that seem to be raring to go in cleaning up the corruption within the FDA etc and Big Pharma. Thanks for posting this article.

I sold everything.  Big loss but wasn't going to wait this out further.  It's a shame mgmt was so confident back in April.  Baby biotechs simply haven't been good to me.  

When the lower dose appears to work better than the higher dose, the straw-grasping begins.

Seasoned pharma aficionados know that in reality it was a data artefact and that means the drug doesn’t work, which is why neither dose was better than placebo.

Quelle surprise.

GALT bad results 

Ok I wasn't sure if your referring to bixt Galt or both.  Mike sheikh is part of bixt.  Not Galt as far as I know.  Are they both scams or just Galt? 

Nope. I never short stocks. Too risky.

I'm in the camp that thinks GALT/PRWP has always been long on lies and short on real drug candidates.

So your in the short camp?  

Adam F is right about GALT, just like The Boston Globe was right about PRWP, GALT’s previous incarnation.

https://www.thestreet.com/investing/stocks/biotech-stock-mailbag-aspenbio-10741455

https://www.insiderfinancial.com/post/short-mafia-attacking-galectin-therapeutics-nasdaq-galt-ahead-of-planned-year-end-readout

https://www.insiderfinancial.com/post/galectin-therapeutics-nasdaq-galt-disrupting-mercks-cancer-dominance

GALT MENTIONED IN THIS ARTICLE

https://www.zerohedge.com/news/2024-10-15/what-merck-doesnt-want-you-know-about-keytruda

Please watch this and comment your opinion

Any company that has Ben Carson on its BoD is doomed to failure.

Good things about to happen here

https://www.globenewswire.com/news-release/2024/06/27/2905450/0/en/Bioxytran-s-Advisor-Releases-Book-on-Hyperbaric-Oxygenation-Related-to-Stroke-Alzheimer-s-Patients.html

https://medicaldialogues.in/medicine/news/galectin-3-promising-biomarker-for-predicting-long-covid-among-patients-of-covid-19-study-129158

Todays emerging growth conference
CEO DAVID PLATT $BIXT
BioxyTran.

https://emerginggrowth.com/emerging-growth-conference-70/

https://www.nasdaq.com/press-release/6-stocks-positioned-to-soar-as-investors-focus-on-mash-2024-04-22

Reached a peak.

Letting some air out today !!

But I had 20,000 !!!

AND AT 2.45...YA GOT ME BEAT BIG TIME!

ONLY...LOL...I ONLY HAVE A 1000..NICE WORK CHAMP!!

Man , I only bought 5000 shares at 1.20 . Happy but I should have loaded the boat a bit more.

GALT...THESE BIO BEAST OF THE BIO MARKET