TG Therapeutics Inc (TGTX)

The Quest to Repair What Multiple Sclerosis Takes AwayJune 24, 2026 9:00 AM
InvestorsHub NewsWireThe Quest to Repair What Multiple Sclerosis Takes AwayBioMedWire Editorial Coverage: Multiple sclerosis ("MS") gradually strips people of command over their own bodies, advancing steadily with no available cure. More than 2.9 million people across the globe are currently living with the disease. But even with generations of scientific study and research, every approved treatment still falls short of one essential objective: bringing the disease to a complete stop. Existing therapies can slow its advance, but none can halt it outright. That shortfall translates into a future of mounting disability for millions of MS sufferers. Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (Profile) is determined working to change that outcome. The company is developing Lucid-MS, a patented, first-in-class drug candidate that approaches the disease from an entirely different angle by directly targeting the myelin sheath that MS destroys; the potential treatment is now preparing to move into phase 2 clinical trials. Quantum BioPharma stands among a group of companies pursuing therapies for neurological, autoimmune and immune-mediated conditions, a group that also includes Novartis AG (NYSE: NVS), Merck & Co. Inc. (NYSE: MRK), TG Therapeutics Inc. (NASDAQ: TGTX) and Bristol Myers Squibb Company (NYSE: BMY).Multiple sclerosis is especially destructive because of its tendency to worsen progressively.Instead of working through the immune system, Quantum BioPharma's Lucid-MS acts directly on the myelin sheath.The scientific case behind Lucid-MS rests on years of disciplined research.Quantum BioPharma has finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302.Click here to view the custom infographic of the Quantum BioPharma editorial.A Disease That Erodes Movement, IndependenceMultiple sclerosis is a long-term inflammatory condition affecting the central nervous system. In MS, the immune system mistakenly attacks the brain and spinal cord, damaging myelin, the protective coating around nerve fibers that allows electrical impulses to travel efficiently. As myelin breaks down, these signals slow, falter or fail altogether, resulting in a mix of symptoms that can include tingling, vision disturbances, mobility difficulties, cognitive decline and, over time, a progressive erosion of physical control.MS does not spare any age group. The worldwide average age at diagnosis is 32, with an estimated 1.5% of all those with MS diagnosed before turning 18. Women receive an MS diagnosis at twice the rate of men. Within the United States alone, close to one million people are currently living with the disease in the United States, a number that more than doubled over earlier figures once researchers applied more rigorous, contemporary counting methods. Unfortunately, the trend continues upward, with prevalence climbing in every region of the world since 2013.In addition, MS is especially destructive because of its tendency to worsen progressively. Many patients initially experience a relapsing-remitting pattern, in which symptoms flare and then partially subside. Over time, however, a substantial share of patients shift into secondary progressive MS, a phase marked by steadily accumulating disability. According to the National MS Society, many people with MS end up juggling several medications at once, with each med addressing a separate symptom or relapse episode, yet none capable of confronting the underlying nerve damage that continues to erode their quality of life.The disease also imposes a substantial financial toll. The worldwide market for MS therapeutics was valued at roughly $27.4 billion in 2024 and is projected to climb to $38.62 billion by 2030, a trajectory driven not by curative treatments but by the sheer volume of patients requiring care across their lifetimes. That market dynamic highlights just how large the unmet need truly is. Patients require more than ongoing management; they need a therapy capable of interrupting the disease process itself.That is exactly the objective Quantum BioPharma has set out to achieve. The company is advancing Lucid-MS, a patented, first-in-class drug candidate unlike any therapy currently on the market, one engineered to act on the myelin sheath directly with the aim of preventing and protecting its breakdown.Acting Directly on the Myelin SheathThe majority of approved MS treatments function by modulating the immune system. They subdue or redirect the immune response responsible for attacking myelin, an approach that can lower relapse frequency and slow the buildup of disability. These therapies have delivered genuine clinical progress. Yet none of them directly address the myelin tissue itself or work to rebuild what has already been lost. For patients in the progressive stages of MS, immune modulation alone frequently proves inadequate.Lucid-MS charts an entirely separate course. Known technically as Lucid-21-302, the candidate is a patented New Chemical Entity, classified as a first-in-class, nonimmunomodulatory, neuroprotective compound. Instead of working through the immune system, Lucid-MS acts directly on the myelin sheath. In preclinical models, it has demonstrated the ability  to protect  myelin from degradation, a key pathological process  underlying multiple sclerosis. No currently approved treatment offers a comparable mechanism of action.A defining feature of Lucid-MS is that it does not impact immune function. That quality separates it from most existing MS therapies and may translate into a meaningful safety benefit. It also frames Lucid-MS not as a substitute for immune-modulating drugs but as a potential complement to them, or should future trial results support its early promise, as a foundational therapy in its own right. The drug is also being advanced in an oral form, which would offer patients greater convenience than the injectable or infusion-based treatments many currently rely on.Quantum BioPharma controls exclusive global rights to Lucid-MS through its wholly owned subsidiary, Lucid Psycheceuticals Inc. The program is guided by a top-tier scientific team that includes advisor Dr. Lakshmi P. Kotra, recipient of the Julia Levy Award, a senior scientist at the University Health Network and a professor of medicinal chemistry at the University of Toronto. The scientific team also includes Dr. Andrzej Chruscinski, vice president of Scientific and Clinical Affairs, whose career spans Stanford-trained internal medicine alongside cardiology and neurological research. This group is working toward something no approved drug has yet accomplished: an MS therapy that directly safeguards myelin.From Laboratory Findings to Human StudiesThe scientific case behind Lucid-MS rests on years of disciplined research. The compound has undergone study for upward of a decade, with findings published in some of medicine's most respected journals, including the "Journal of Medicinal Chemistry" and the "Proceedings of the National Academy of Sciences." These peer-reviewed papers track the compound's indicated capacity to prevent demyelination in preclinical settings.The animal-model results are notable. Across experiments carried out in multiple laboratories over the course of several years, Lucid-MS sped up functional recovery in mouse models of MS, preserved myelin integrity and reduced regional degradation. Documented results report that, following treatment, mice regain the capability to walk. This outcome did not stem from isolated experiments but from an extensive body of studies. The results proved compelling enough to justify advancing the compound into human trials.Quantum BioPharma presented its phase 1 clinical trial application for Lucid-MS to evaluate first-in-human safety and tolerability in 2023. The trial encompassed both Single Ascending Dose ("SAD") and Multiple Ascending Dose ("MAD") phases, which were administered among healthy volunteers. Results from the clinical study report identified no safety or tolerability concerns associated with daily dosing. Dosing in phase 1 among healthy human volunteers was successfully completed, with Lucid-MS characterized as exhibiting a favorable safety profile and good tolerability.Should upcoming phase 2 trials in MS patients confirm what the preclinical work suggested — that Lucid-MS can stop and prevent myelin degradation — it would represent an unprecedented milestone. No therapy currently approved for MS has shown the ability to help patients regain physical function previously lost to myelin damage. While human trials remain necessary to determine whether the preclinical results carry over to patients, a decade's worth of accumulated data provides a scientifically credible basis for that optimism.Submitting the IND, Preparing for Phase 2Late last year, the company finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302. These studies represent essential elements of the Investigational New Drug ("IND") application that the U.S. Food and Drug Administration ("FDA") requires before authorizing a phase 2 trial. Completing these extended safety studies marked a meaningful advance toward formal regulatory submission.The company additionally entered into agreements with a leading contract development and manufacturing organization to develop and produce an oral formulation of Lucid-MS, a critical step in preparing the drug for clinical use. Following that, in April this year, Quantum BioPharma officially filed its IND application with the FDA for Lucid-MS, aiming for a phase 2 trial designed to assess the therapy's efficacy, safety and tolerability among people living with MS.To carry out a phase 2 trial, Quantum BioPharma announced a binding letter of intent with Allucent, a global contract research organization with extensive experience running central nervous system trials. Quantum BioPharma also named a principal investigator for the upcoming trial, marking further progress in the clinical development program. These steps are indicative of an organization that has advanced methodically from encouraging preclinical results to taking the steps towards producing the human clinical data the MS community is waiting for.A Pioneering Partnership Sheds Light on the Path ForwardQuantum BioPharma is concurrently working with a tool that could prove vital to assessing Lucid-MS's effectiveness: an advanced imaging technique capable of directly visualizing myelin within the living human brain. Quantum BioPharma recently launched a joint clinical study with researchers at Massachusetts General Hospital ("MGH") to validate a novel positron emission tomography imaging method for tracking myelin integrity and demyelination in MS.The study centers on a PET tracer known as [¹8F]3F4AP, developed by Dr. Pedro Brugarolas, who is an investigator in the Department of Radiology at MGH and an assistant professor at Harvard Medical School. Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and an associate professor of neurology at Harvard Medical School, is co-investigator on the project.In June of last year, the first patient with MS was scanned successfully, which marked the formal start of active patient enrollment. The MGH research team also published encouraging results in the "European Journal of Nuclear Medicine and Molecular Imaging," in a study funded by the National Institutes of Health. The tracer exhibited strong properties for brain imaging and, notably, was able to distinguish differences among lesions that conventional MRI could not detect. Last month, the study reached the midpoint of patient enrollment, with preliminary imaging results showing encouraging signal strength in acute MS lesions.The importance of this imaging work to Lucid-MS's development is difficult to overstate. One of the central challenges in developing any remyelinating therapy is confirming whether it is genuinely working, and conventional MRI cannot provide a direct, quantitative measure of myelin. Assuming it is validated, the [¹8F]3F4AP tracer could supply precisely that: a real-time biological window into how effectively a drug is protecting or restoring the myelin sheath.Chruscinski has noted that this tool has the potential to fundamentally reshape how demyelination is assessed, offering a direct view into axonal health and enabling clearer demonstration of how therapies such as Lucid-MS perform. This collaboration among the University Health Network, Massachusetts General Hospital and researchers affiliated with Harvard Medical School brings together world-class scientific expertise around a common purpose.Quantum BioPharma is laser focused on that objective. With the global MS therapeutics market projected to surpass $38 billion by 2030, the commercial stakes involved are substantial. Yet for the nearly three million people living with MS worldwide, what matters most is whether a therapy can finally achieve what none has accomplished before: Halting the disease, repairing the damage it causes and restoring the bodily control that MS has taken away. Should Lucid-MS fulfill its preclinical promise in human trials, it would represent more than a new drug; it would mark a genuine turning point.Advancing Treatment Options Across SectorsRecent developments across the biopharmaceutical industry highlight continued momentum in the development of therapies for autoimmune, immune-mediated and chronic inflammatory diseases. Companies are reporting encouraging clinical results, expanding development programs and achieving important regulatory milestones as they work to address conditions that can significantly impact quality of life and often remain difficult to treat.Novartis AG (NYSE: NVS) presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology ("EAACI") Congress. The data showed that Rhapsido(R) (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines.Merck & Co. Inc. NYSE: MRK) announced positive topline results from the phase 3 ATLAS-UC induction-only study (study 2). The study evaluated tulisokibart ("MK-7240"), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A ("TL1A"), in patients with moderately to severely active UC. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score at week 12, as well as key secondary endpoints. In addition, consistent with previously reported phase 2 studies, no safety concerns were identified.TG Therapeutics Inc. (NASDAQ: TGTX) reported positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis. The company also announced theinitiation of a phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG. The company noted that the encouraging results support continued development of BRIUMVI in MG and also mark an important milestone in expanding the potential utility of BRIUMVI beyond multiple sclerosis.Bristol Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved Opdivo(R) (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine for the treatment of adult and adolescent patients 12 years of age and older with previously untreated stage 3 or 4 classical Hodgkin lymphoma. This approval marks a significant milestone, establishing the Opdivo plus AVD combination as the first immunotherapy-based regimen available in the European Union for newly diagnosed advanced cHL.As scientific understanding of immune system dysfunction continues to evolve, researchers are uncovering new therapeutic targets and refining treatment strategies across a broad range of diseases. These efforts reflect a growing focus on delivering therapies that offer greater efficacy, convenience and durability while helping address substantial unmet medical needs.For further information about Quantum BioPharma Ltd., visit the Quantum BioPharma profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. 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TGTX, 10Q due MONDAY 3/3

I think we will see a delayed (few days) response to the news.
I am expecting that this will run to $27 by next week and $30 by October.
Definite buyout candidate within the next year. Especially if interest rates are dropping.
JMO.

Could not agree more.

I don’t think they are long for this corporate world as an independent entity.

Murocman

I had to buy some Premarket. This company is a gold mine IMO.
I love stocks near 52 week high. The upward potential here is limitless.
Really excited for the next few months.
I definitely see this company being bought out in the next 52 weeks.

Great news today. Stock at 52-week high.
Just announced $100 million stock buyback.
Compelling story here.
JMO.

TGTX new 52 week high

this should have a very good day tomorrow absent a market meltdown. MS drug par excellence.

I would think we’d be close to the bottom here? Almost at a 52 week low!

GLTA,

Murocman

Cheap at these levels. Should see $20 again before long. Friday should be interesting. If script numbers are good, like last Friday, the share price should get a good boost. Half way through Q3. Dumb drop from $21 to $9.

$TGTX CEO Weiss buys 100k shares at 10.13. Now has 12 million shares

Barely above pre-approval prices. Unbelievable.

Murocman

Anyone catch that Genetech is starting to air commercials since they are losing share?

Great call this morning. Nice run today and just the beginning with Europe coming on soon.
After Hours Time (ET) After Hours Price After Hours Share Volume
17:27:17 $30.5 5,000
$152,500 in one trade. Short covering???
Fun to think about market cap in 2024 and 2025.

Where did you find such news?

Has anyone checked out $GSTC? Similar biotech company like $TGTX except its much newer and has a patented formulation combinational therapy already FDA approved set and waiting for clinical trial approval in India for Multiple Sclerosis. It is an over-the-counter stock sitting over .01 just waiting for clinical trials approval. The market cap is on $8,000,000. The therapy isn't specific to the type of multiple sclerosis. So, the potential here is huge. The conservative market share that was done by seasoned professionals in the space, that is on their presentation is in the BILLIONs. Read the history here: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170524593

Whens the buyout..?

Lol

Looks like tuseday is shorting day .

They have cash and a better MS drug have the price of Roches. Shorts don’t like

$TGTX: Not only that but they must be...............

On the wrong side of the trade.

When you get squeezed on them nards, it never feels good.


No mercy....... TAKE THEM OUT !!!!!!!


GO $TGTX

Analysts keep on giving it bad sell ratings.
That must be a good sign. Analysts for the most part just share selling scam artists

$TGTX: Slowllyy creeping up..... now 11.50 in PreMarket

If it can do exactly what $KALA just did by going over $45, I'm a happy camper


GOOOOOOOOOOOooooooooooooooooooooooooooo hardddddddddddddddddddd



GO $TGTX

Traded@55.70 Jan 8 ‘21… looks like she’s still got quite a bit togo…

Dosing of first patients in 30 to 45 days from now/going to the market!!

$TGTX No offerings on the horizon per CC

$TGTX No offerings on the horizon per CC lfg— Cooway Trades 🐊 ⛪️🚀🇺🇸🙏🏽 (@cooway) December 29, 2022

Link to 8;30 webcast/conference call.
https://ir.tgtherapeutics.com/events

Some informative information, pictures of the packaging, disease overview, and more.
https://ml.globenewswire.com/1.0/snippet/1898/eng

TG Therapeutics Announces FDA Approval Of BRIUMVI; Company To Host Conference Call On Thursday, December 29, 2022 At 8:30 Am ET

Given a try; on this one in at 8:47 for a morning was jump !!
See if shorts cover before the weekend ??

Yeah, we may get mm naked! shorts covering tomorrow. Share price may
spike./;)) early GL$$

They have cash and they would let the price go much higher before another offering

$8.73 after hours On a good note company conference 830am and market makers

Probably an offering coming.

Unfortunately lots of illegal naked shorts courtesy of Gary G but see what happens next few days as more shorts cover.
Never a easy game kept a few shares

Damn how low is this going? Not headed in right direction at the moment.

MS drug going to make hundreds of millions..

Dec 28 (Reuters) - TG Therapeutics Inc said on Wednesday that the U.S. health regulator had approved its monoclonal antibody for treating patients with relapsing forms of multiple sclerosis, sending its shares up nearly 9% in afternoon trade.

The approval by the U.S. Food and Drug Administration (FDA) widens the number of such drugs available for treating the disorder to three and may help soften the blow to the company's finances from the withdrawal of its lymphatic cancer drug earlier this year.

TG Therapeutics said it was expecting to launch the drug, branded as Brumvi, in the first quarter of 2023, but did not give details on its pricing.

Jefferies analyst Chris Howerton said ahead of the approval that he was expecting the drug to be priced in the range of $30,000 per patient per year. In comparison, Roche's Ocrevus has a current list price of about $68,000 annually.

Multiple sclerosis is a neurological disease in which the immune system attacks the brain cells causing motor disabilities. It affects about 400,000 people in the United States, according to the National Institutes of Health.

Unlike other MS drugs that target T cells, Brumvi belongs to a class of drugs that tackles B cells' role in driving the inflammation that is central to neurological disease.

The approval, which comes with a warning of infusion reactions from the drug, was based on a late-stage study that showed the drug was effective in reducing the annualized relapse rates in patients. (Reporting by Sriparna Roy, Khushi Mandowara and Raghav Mahobe in Bengaluru; Editing by Anil D'Silva and Shailesh Kuber)

Nice Pump Moon Market

As usual they going to scare folks into
Selling there shares loooks like upper $8s bottom

Still holding about 20% regular short interest and then all the illegal naked Gary G approved ones

$TGTX: Opens at $11...........


Only the beginning now


GO $TGTX

Can be whatever you want if we see $40s..lol

God damn thought you were a woman this whole time

$TGTX: I showered.............

Balls, armpits and buttcrack............. good to go.

Took 2mins


GO $TGTX

220pm stand corrected
alfred

@macronewswire
TG THERAPEUTICS (TGTX)TO RESUME TRADING AT 2:20 P.M.
$TGTX

I'm hearing within the next hour... everyone wins!!

$TGTX: Fantastic !!!!!!!!!!!!!


Works for me



GO $TGTX

Halted I believe until 830am
Press release tomorrow. Don’t take my word but pretty sure

$TGTX: Whats the big deal about PKPH ???

Did they just get an FDA approval like $TGTX ??

GO $TGTX