Galectin Therapeutics Inc (GALT)

But but but belapectin failed its pivotal Phase III trial.

There may be a signal but there was no statistically significant “benefit” in the primary endpoint in this first place, so obviously it can’t have “kept going”.

I understand that GALT would like to sacrifice science to Mammon - a common desire nowadays it appears- but the real world doesn’t work that way.

Perhaps if they conducted a new study instead of trying to draw rings round the bullet holes that missed the original target, they might get somewhere.

Although the data around belapectin has always been iffy, just like PRWP -
aka GALT - and just like Jim Czirr.

4. The 36-month follow-up CONFIRMED the benefit keeps going — something almost no MASH drug has ever shown.
At 36 months:

• New varices incidence: 12.4% at 2 mg/kg vs 23.4% placebo
The advantage persisted for 3 years.
This is extremely rare in cirrhosis.

• Biomarker improvements remained stable
PRO-C3, ELF, liver stiffness all stayed improved.

Durability is critical:
Many drugs show an early signal that disappears later.
Belapectin’s signal strengthens with time.

No other MASH drug has shown a 36-month antifibrotic durability signal with matching clinical outcomes.

cut with the conspiracy theories.

"They should be, up 1.20"

Why? GALT's own trial showed that belapectin doesn't work.

No amount of spinning by the investigators or the company itself can make a silk purse out of the sow's ear that is belapectin's performance in the NAVIGATE study where it simply failed to meet the primary endpoint.

Period.

PS if GALT's main direct and indirect shareholder, ex-CEO and founder Jim Czirr, is still hiring social media pimps to do his dirty work for him, he should probably stop. It's not helping and it's probably illegal.

They should be, up 1.20
buying more today.

Nice to be deep green.

As it deserves to. Jm Czirr must be very unhappy that his decades-long con is failing.

As it deserves to. Jm Czirr must be very unhappy that his decades-long con is failing.

GALT bleeding out.

New FDA guidance document

Very favorable for GALT

Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

Short sellers are getting worried.

The squeeze ranking is near the top.

"Boy, did Management screw the shareholders, or what."

They were only obeying orders from the founder and majority owner of GALT, fka PRW and PRWP.

Ask Glycobio who that is.

But here's a hint (that doesn't include all the shares controlled by that individual):

https://www.quiverquant.com/insiders/1260641/Czirr-James-C

Boy, did Management screw the shareholders, or what.

Just proved that user sunspotter is dishonest

This link might be useful for those who have been hoodwinked by Jim Czirr and his GALT cronies:

https://bgandg.com/GALT/?utm_source=accesswire&utm_medium=pressrelease&utm_campaign=GALT

"Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Galectin Therapeutics Inc. (“Galectin” or “the Company”) (NASDAQ: GALT). Investors who purchased Galectin securities are encouraged to obtain additional information and assist the investigation.

The investigation concerns whether Galectin has violated federal securities laws."

As erniewerner pointed out many years ago, there's never just one cockroach in the kitchen.

"random internet poster with zero experience in the liver field"

Actually I have a lot of experience in hepatology and medicines that actually work in liver disease, garnered over 40 years in the Pharm and MedTech industries.

I also understand what it means when a trial fails to meet its primary endpoint, and why that automatically renders all secondary endpoints invalid.

The latter is an absolute truth. It's not my fault if, as Upton Sinclair commented:

"It Is Difficult to Get a Man to Understand Something When His Salary Depends Upon His Not Understanding It."

LOL it's a random internet poster with zero experience in the liver field who calls himself sunspotter vs. independent experts who specialize in liver disease:

November 2025 -
Raj Vuppalanchi, M.D., serves as Professor of Medicine and Director of Hepatology at Indiana University School of Medicine, stated “...The sustained improvements in liver stiffness and multiple serum biomarkers, including ELF, PRO-C3, and YKL-40, are particularly noteworthy, as they collectively suggest a consistent antifibrotic effect and stabilization of disease. These results are encouraging for patients with MASH cirrhosis and portal hypertension, a population with few effective therapeutic options.”

The only fact about belapectin that matters:

“ 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”

https://www.globenewswire.com/news-release/2024/12/20/3000560/27423/en/Galectin-Therapeutics-Announces-Top-Line-Results-of-NAVIGATE-Clinical-Trial-Evaluating-Belapectin-in-Patients-with-Cirrhotic-Portal-Hypertension-Caused-by-MASH.html

In the real world where one is not being paid to say otherwise, or where one doesn’t hold stock in the company or is not being paid to conduct clinical trials and misrepresent the results of those trials at scientific meetings, it means that so far actual clinical trial results say belapectin doesn’t work.

Sorry about that.

“In the recent years since then he has zero involvement with the company - and he’s not even on the board anymore”

What percentage of GALT does Jim Czirr or funds that he owns or is associated with own?

Tell me the answer to that and then tell me with a straight face that swindler Czirr isn’t associated with GALT fka PRWP any more.

Mr. Market wasn’t born yesterday, you know.

Yes Palmeranz (sic) law and the rest of the ambulance chasers always have an investigation every time I biotech has a bid sudden drop in share price. I don't put too much Credence in that. The Wall Street journal had an article that stated as it were a fact that the FDA had problems with the trial design. The pr from the company and from what you're saying is that the FDA and the company in agreement regarding the trial design. I know there's always a lot of hit pieces that say things is there are a fact but usually I don't see those coming out of Wall Street journal. Maybe the short sellers in this company had a little better connections to the media doing their bidding for their short selling campaign. 

You seem to have a personal vendetta against Jim. Note that he is a venture capitalist and provided seed funding money for initial development about 15 years ago. In the recent years since then he has zero involvement with the company - and he’s not even on the board anymore. Why don’t you go and challenge Jim in the MMA ring instead of bashing the whole company, when you clearly have a personal grudge going on with someone.

Calm down.

It's not my fault belapectin failed to meet its primary endpoint, but not a surprise after watching Jim Czirr's two plus decades of lying about it.

PRWP still stinks even if it has a new name - GALT- and a (failed) clinical trial to its name.

“ I do think the clinical results have been good so far. ”

What, the results where the primary endpoint was missed and so all the secondaries were automatically rendered moot?

While it’s good that a well designed study led to the conclusion that belapectin didn’t work in that trial, it’s a shame that so many people try to pretend the opposite.

That might explain some of the skepticism around this latest iteration of Jim Czirr’s long running scam.

If you're waiting to see if they have cash, they are strong in that area because the billionaire backer chairman (who put in more than $100 million of his own cash) publicly stated in a prior PR that funding will not be an issue and that outcome will be based on results instead. They are good through 2027 as it stands now, given his recent addition of another $10 + $10 = $20 million.

As far as ambulance chaser law firms, that is routine spam junk for these biotech companies. By typing this sentence I already gave it more attention than the spam lawsuits are worth LOL.

I hear that good things are coming out of the MASH-TAG conference this week. The company is being low profile (during pharma negotiations?) but the CMO is attending, and several of the topics are related to the FibroScan and Pro-C3 biomarkers that GALT could use as additional supporting biomarkers for accelerated approval.

Sounds good. Thank you. Now all they need to do is overcome the negative sentiment surrounding the insider selling and the investigations by the ambulance chasing class action securities law firms. I might wait to see if they can raise cash to get them through. I do think the clinical results have been good so far. 

Jimmy, see in the press release the FDA agreed on the patient population.

That is a huge positive development because that is precisely where companies face hurdles in p3 planning.

This means the FDA is onboard with GALT’s next step and just need to iron out more of the details.

A written response is routine when the FDA does not have major concerns. In fact, if the FDA had big concerns they would want an in-person meeting to go over what their concerns are.

Very bullish, I bought more.

Correction do you know what The insider selling is all about?

Do you know why the FDA refused to give them a type c meeting and sent some letter instead? And do you know what the recent entire selling is all about? Stock looks like it's really caving in and we're not hearing anything from management about what was in that letter from the FDA. I haven't looked into what the lawsuit investigation from the securities litigation ambulance chasers is all about. I am definitely unhappy with management the way they handled this situation.

I will have to find some better sources of news. I didn't hear of the issues regarding the insiders selling until after the damage was done today. Probably too late to sell now maybe a better idea to buy more. Usually these drops for inside or selling to pay their tax bills are a good opportunity to buy cheaper as the only thing it shows is inside needed some cash to pay their taxes.

Still amazes me how under the radar this is

Raj Vuppalanchi, M.D., serves as Professor of Medicine and Director of Hepatology at Indiana University School of Medicine, stated “The long-term NAVIGATE data presented at AASLD provide important insights into the potential of Galectin-3 inhibition in advanced fibrosis. The sustained improvements in liver stiffness and multiple serum biomarkers, including ELF, PRO-C3, and YKL-40, are particularly noteworthy, as they collectively suggest a consistent antifibrotic effect and stabilization of disease. These results are encouraging for patients with MASH cirrhosis and portal hypertension, a population with few effective therapeutic options.”

Galectin Therapeutics’ fibrosis results are extremely bullish because they show clear, consistent, and statistically meaningful HVPG reduction in NASH cirrhosis while also demonstrating broad biomarker confirmation that the drug is actively shutting down fibrogenesis. HVPG responders (≥20% reduction) appeared without safety issues, and this is the FDA-recognized gold-standard surrogate for preventing decompensation, variceal bleeding, transplant, and death. At the same time, the latest biomarker readout showed meaningful declines in PRO-C3, lower rates of PRO-C4 worsening, and higher proportions of patients achieving YKL-40 reductions, all pointing to real suppression of collagen production and inflammatory remodeling. These biochemical shifts matched the improvements seen in non-invasive measures (LSM/FibroScan and ELF), with belapectin cutting high-risk fibrosis progression rates in half and increasing the share of patients moving into lower-risk Baveno VII categories. Belapectin directly targets activated macrophages and interrupts the upstream fibrosis engine rather than just reducing liver fat or inflammation like other NASH drugs. And because the strongest HVPG improvements occurred in patients without baseline varices—precisely the group the FDA prefers for accelerated approval—the combined hemodynamic, biomarker, and safety profile strongly implies accelerated-approval viability and a multi-billion-dollar valuation trajectory in a space with no competitors.

Nothing GALT and its pimps like better than painting target holes around existing random bullet holes.

From another board, good stuff:

Why GALT’s Fibrosis Data Are Better Than Any Other MASH Company
1. They are showing fibrosis improvement in true compensated cirrhosis (F4) — the population where EVERY OTHER DRUG HAS FAILED.
Almost all other “great” fibrosis results in MASH come from F2–F3 populations (Akero, 89bio, Madrigal).
Fibrosis moves easily there.

But in biopsy-confirmed F4 cirrhosis with portal hypertension, fibrosis essentially does not reverse in modern trials.
This is why Gilead, Intercept, NGM, Novartis, Genfit, and Madrigal all failed in this population.

GALT is the first to repeatedly show biomarker improvement AND fewer clinical events in compensated cirrhosis.

No other company has done that.

2. The magnitude of fibrosis-biomarker improvement is unusually large and consistent across ALL major antifibrotic markers.
At 18 months (NAVIGATE):

• Pro-C3 reduction: >50% vs baseline
This is the main “fibrogenesis” marker.
Competitors usually get ~20–30% reduction in easier F2–F3 patients.

• ELF score: clinically meaningful drop
Again, competitors rarely get ELF improvement in cirrhosis.

• FibroScan liver stiffness: improved
Liver stiffness almost always worsens in F4 patients.
Belapectin produced improvement.

• YKL-40 / other collagen markers: improved
Indicates reduced macrophage-driven scarring.

What’s unique:
Other companies may improve one marker (e.g., ALT, MRI-PDFF, or PRO-C3),
but GALT shows simultaneous improvement across the entire fibrosis parameter set in cirrhosis.

That has not been replicated by any other company.

3. Only GALT has shown a link between fibrosis biomarkers ? portal pressure improvement ? fewer cirrhosis complications.
This is the reason the field is paying attention.

HVPG (portal pressure) improvement
Belapectin produced meaningful drops in HVPG — the FDA’s gold-standard surrogate for preventing variceal bleeding, ascites, transplant, and death.

No other MASH drug has ever shown a consistent HVPG improvement in cirrhosis.

Reduced clinical progression
Belapectin-treated patients developed fewer new esophageal varices, which is the #1 warning sign of impending decompensation.

This matches the HVPG signal.
It matches the biomarkers.

This “full chain” alignment is unmatched:

Fibrosis biomarkers improve

Portal pressure decreases

Varices occur less often

Disease stays compensated

Other companies haven’t shown this chain — not even close.

4. The 36-month follow-up CONFIRMED the benefit keeps going — something almost no MASH drug has ever shown.
At 36 months:

• New varices incidence: 12.4% at 2 mg/kg vs 23.4% placebo
The advantage persisted for 3 years.
This is extremely rare in cirrhosis.

• Biomarker improvements remained stable
PRO-C3, ELF, liver stiffness all stayed improved.

Durability is critical:
Many drugs show an early signal that disappears later.
Belapectin’s signal strengthens with time.

No other MASH drug has shown a 36-month antifibrotic durability signal with matching clinical outcomes.

5. Mechanistically, belapectin is the only drug directly targeting activated macrophage–galectin-3 fibrosis architecture.
Other drugs target:

Fat reduction (Madrigal)

Metabolic pathways (89bio, Akero)

FGF signaling

Lipid metabolism

Inflammation

Those help in F2/F3 — but not in F4.

Belapectin targets the scaffolding of fibrotic architecture itself by inhibiting galectin-3 on activated macrophages.

This mechanism explains why:

• GALT works in cirrhosis but others fail.
• Biomarker improvements line up across every fibrosis marker.
• HVPG drops.
• 36-month clinical progression slows down.
It’s the right mechanism for the right stage of disease.

6. The field desperately needs a drug for compensated cirrhosis — and GALT is alone.
Every other company is fighting over:

F2/F3

Early fibrosis

Resmetirom-like mechanisms

MRI-PDFF reductions

Triglycerides

ALT normalization

Body-weight changes

But none of that matters in F4.

Regulators, hepatologists, and payers want something that:

Slows portal pressure rise

Prevents varices

Delays decompensation

Reduces need for transplant

Only belapectin has shown all of that together.

THE SIMPLE ANSWER
GALT’s fibrosis data are better than any other MASH company because they succeed exactly where every other program has failed: reversing fibrosis biology, lowering portal pressure, and slowing clinical progression in real compensated cirrhosis — with signals that persist out to 36 months and are consistent across all major biomarker categories.

No other company in MASH has shown:

deep PRO-C3 reduction

ELF improvement

liver stiffness improvement

HVPG reduction

fewer varices

36-month durability

in true F4 cirrhosis

with a fibrosis-architecture mechanism

GALT is alone in that category.

Interesting article on the systematic loss of health independence.
https://interestofjustice.substack.com/p/the-unscrupulous-global-syndicate?img=https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Ff65f168f-34e0-4e69-802b-bcf1896004ef_1536x1024.png&open=false

https://interestofjustice.substack.com/p/appeal-against-gates-and-pfizer-ceo?publication_id=825071&post_id=173754961&isFreemail=true&r=x7hm&triedRedirect=true

New fda guidelines out and wow, they are bullish for galt. 

If this closes above $4.28 the next resistance point comes into view. 

lol what a clown response. 

You (or rather your AI) didn't answer the actual question. It also hallucinated somewhat.

I'm sure you can do better.

Why no reply sunspotter?? A simple, I was incorrect would suffice. 

Jesus you're still here sunspotter I thought you would have covered by now oh well..... If you're looking for a comprehensive readout of the overall odds of approval as determined by artificial intelligence that is completely unbiased using only the data available to the public
[url][/url][tag]https://www.perplexity.ai/search/given-the-primary-endpoint-fai-RYDoBwF2SAmL.2PZCBDOTg[/tag] I'm pretty sure that's pistol Pete by the way

As you can clearly read, 10%+ of approvals for your 'criteria'. 
Let me know when you change your mind. This drug will get approved. 

Please stop with the ad hominem attacks. It demeans you.

Facts are a good starting point, rather than personal attacks.

So, two short factual questions, and see if you can answer them:

1) Has belapectin met its primary endpoint in a Phase III study?

2) Do regulatory agencies in the developed world consider secondary endpoints to be valid if the primary endpoint has not been met?

Also consider that if a Bayesian approach were taken (in general I think that's a better way although most agencies do not agree) , the counterintuitive results from the 4 mg/kg arm would also confound the "trend" that GALT and its adherents are so keen to trumpet.

Thanks in advance for the courtesy of a courteous reply.

This sunspotter is so arrogant, he/she thinks they know more than the world's top experts in hepatology. Look up the credentials of the names below. Then compare the credentials against some random anonymous internet street person.

Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam

"I could list a number of examples that prove you're wrong, but you likely know that already."

Please do, because I certainly don't know that already, and I'm always willing to be corrected when wrong.

I would be grateful if you could list a number of examples (ideally three or more) where FDA has approved a drug candidate which had only one Phase III study to its name, and where that drug had failed to achieve its primary endpoint in that same study.

Thanks in advance.

I could list a number of examples that prove you're wrong, but you likely know that already. 

I’ll wait, don’t worry.

Even though a certifiable lunatic is now in charge of DHHS, FDA will never approve a drug with only one Phase III study.

Especially when that study demonstrated that the subject of the trial did not achieve its primary end point.

Just wait for it. Bella is going to get approved. 

Bless you heart, Glycobio, I'm sorry that belapectin failed to hit its primary endpoint in the NAVIGATE study and that therefore all the secondary endpoints are rendered moot and invalid.

But that's not my fault, and I think you should refrain both from ad hominem attacks on me, and from falsely claiming that belapectin reduces varices development in MASH when there's no statistically significant evidence (just a "favorable trend" and a complete failure - worse than placebo! - in the higher dose group) :

"In the intent-to-treat (ITT) population (N=355)........................ the composite endpoint did not reach statistical significance."

https://investor.galectintherapeutics.com/news-releases/news-release-details/galectin-therapeutics-announces-top-line-results-navigate



Thanks in advance!

"If the dropouts are ignored it hit stat significance."

If the other side hadn't scored more goals we would have won"

L)OL!