Argen-X

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piddybull
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Argenx

The Argonauts were able to achieve the unthinkable.







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piddybull
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Argenx

The Argonauts were able to achieve the unthinkable.

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piddybull
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Re: Argen-X

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De doos van Pandora!

https://gmgcycle.com/home.html
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Argenx

The Argonauts were able to achieve the unthinkable.

Gentse strop
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piddybull schreef:
10 okt 2020 15:59
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De doos van Pandora!

https://gmgcycle.com/home.html
piddy, all-in on Argenx? Geen gala of trigano meer?

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piddybull
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Re: Argen-X

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De afgelopen weken voldoende € gerecupereerd met korte Barco - GLPG - Trigano trades.
Nu inderdaad even eenvoudiger maar goed bewust dat er steeds gevaren kunnen loeren.
Argenx

The Argonauts were able to achieve the unthinkable.

mongoose
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piddybull schreef:
10 okt 2020 15:59
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De doos van Pandora!

https://gmgcycle.com/home.html
Ik zal een keertje registreren, 5K is een hapje als marathonloper.

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piddybull
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Een nieuw ATH ! € 240,00
Géén vuurwerk maar bloemen...genaamd vuurwerkbloem.

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The Argonauts were able to achieve the unthinkable.

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Re: Argen-X

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Maar wanneer winst nemen in aanloop naar deze mini lockdown?
Argenx blijft een aparte in mijn porto. Kent vaker periodes van stijging zonder dat daar nieuws aan vooraf gaat of dat er nog iets specifieks wordt verwacht..

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Lama Daila
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https://seekingalpha.com/article/437878 ... -gmg-space

Argenx: Competitive Positioning In The GMG Space

Summary
ARGX is up nearly 15-fold since we first covered it positively in 2017.

Now that it is approaching the market for the current lead indication, we still see some upside to the stock.

We think it is a long term hold-able stock.

Looking for more investing ideas like this one? Get them exclusively at The Total Pharma Tracker. Get started today »

We last covered argenx SE (ARGX) in December 2018; we said that it is a below-radar potential winner. The stock price at publication was $101.28 - today it has nearly tripled. At that time we discussed phase 2 trial results of the company’s lead candidate efgartigimod (ARGX-113) in generalized myasthenia gravis (gMG). A phase 3 trial had just been initiated. In this article, we revisit the company to discuss the results from the phase 3 ADAPT trial, how argenx targets to deliver efgartigimod to patients in 2021, and what its position is vis-a-vis competition like Alexion (ALXN) and the recent approval of soliris in gMG.

Before we begin, a few things to note:

ARGX-113 has been granted Orphan Drug Designation in both the U.S. and Europe for the treatment of myasthenia gravis (MG);

argenx announced positive results from the phase 3 ADAPT trial in May 2020; to be submitted as part of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) by the end of 2020;

The company has $2.17 billion in cash including the $750 million raised in May 2020;

The stock price at the time of this writing is $248.57 (close at 9/25/2020) putting the market cap at $11.49 billion ($268 and a billion more today, Oct 7, 2020);

Nearly 85% of the company’s shares are held by institutional investors, whereas the public holds a little over 15%.

MoA: the key differentiator

MG is a disorder caused by an overactive immune system that attacks the proteins at the junctions of nerve and muscle cells, thereby impairing the communication signals and weakening the muscles. The attack happens with overproduced immunoglobulin G (IgG) antibodies that recycle through neonatal Fc receptors (FcRn). ARGX-113 is a modified antibody that has greater affinity to the FcRn than an IgG antibody, thus blocking the latter’s recycling, and consequently reducing their number.
845062B6-B894-44BB-9F2E-542E262243BC.png
Developed in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)), ARGX-113 has the potential to eliminate MG symptoms and minimize common side effects seen in current treatments. The FcRn targeting MoA represents a potential therapeutic approach in other autoimmune disorders, which the company is investigating. These include:

primary immune thrombocytopenia (ITP) - chronic bruising and bleeding disorder - phase 3;

chronic inflammatory demyelinating polyneuropathy (CIDP) - neurological disease leading to impaired motor function - phase 2;

pemphigus vulgaris (PV) - chronic disease characterized by severe blistering of the skin - phase 2;

A fifth indication is to be announced towards the end of the year 2020.

After successful phase 1 and phase 2 trials for treating MG, the company conducted a pivotal phase 3 clinical trial ADAPT to evaluate the efficacy, safety, and tolerability of ARGX-113 in patients with gMG and a Myasthenia Gravis Activities of Daily Living (MG-ADL) score>=5. Initiated in September 2018, the randomized, double-blind, placebo controlled, multicenter study enrolled 167 participants regardless of antibody status, acetylcholine receptor-antibody positive (AChR-Ab+, 90% of gMG patients) or negative (AChR-Ab). This is a critical difference from Soliris, which works only in AChR-Ab+ patients. Patients were on a stable dose of at least one gMG treatment prior to randomization, including acetylcholinesterase inhibitors, corticosteroids or nonsteroidal immunosuppressive drugs, and were required to remain on that stable dose throughout the primary trial. The participants were randomized in a 1:1 ratio to receive either efgartigimod or placebo for a total of 26 weeks. The study was completed in April 2020 and positive results were announced in May 2020. Excerpts below:

ADAPT met its primary endpoint defined as the percentage of responders on the MG-ADL score among acetylcholine receptor-antibody positive (AChR-Ab+) generalized myasthenia gravis (gMG) patients. Responders are defined as having at least a two-point improvement on the MG-ADL score for at least four consecutive weeks.

Highlights of topline ADAPT data:

67.7% of AChR-Ab+ patients treated with efgartigimod achieved the primary endpoint compared with 29.7% on placebo (p<0.0001).
63.1% of AChR-Ab+ patients responded to efgartigimod compared with 14.1% on placebo on the Quantitative Myasthenia Gravis (QMG) score (p<0.0001); responder defined as having at least a three-point improvement on the QMG score for at least four consecutive weeks.
40.0% of efgartigimod-treated AChR-Ab+ patients achieved minimal symptom expression defined as MG-ADL scores of 0 (symptom free) or 1, compared to 11.1% treated with placebo.
Efgartigimod was well-tolerated with a safety profile that was comparable to placebo.
Statistically significant differences in the efgartigimod arm for AChR-Ab+ patients

MG-ADL responders in the overall population, including both AChR-Ab+ and AChR-antibody negative patients (p<0.0001).
Time on trial in clinically meaningful improvement (MG-ADL improvement ≥2) (p=0.0001).
Fast onset of response on MG-ADL score (onset observed in first two weeks) (p=0.0004).
Time to qualify for retreatment endpoint did not meet statistical significance.
In AChR-Ab+ patients who met the primary endpoint, the majority showed a sustained response, including 88.6% who achieved a response for at least six weeks, 56.8% for at least eight weeks and 34.1% for at least 12 weeks.
Of AChR-Ab+ patients who received a second treatment cycle, 70.6% were MG-ADL responders compared to 25.6% of placebo patients.
90% of patients enrolled in the ADAPT trial continued to the ADAPT-Plus open-label extension study.
Percentage of efgartigimod responders on the MG-ADL score in the AChR-antibody negative patient population was consistent with the AChR-Ab+ patient population, but a greater placebo response was observed in this cohort.
Observations - we note that the focus of the ADAPT trial is AChR-Ab+ patients in terms of the primary endpoint here. This makes sense for various reasons, including the fact that a majority of gMG patients are AChR-Ab+. The trial design also incorporates a combination therapy aspect, with the inclusion of other current treatments in the design.

Alexion’s Soliris

Alexion’s soliris is a terminal complement inhibitor first approved in 2007 as the first treatment for paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Soliris was subsequently approved in 2017 for refractory gMG patients who are anti-AChR-Ab+. In patients with anti-AChR-Ab+ MG, the body’s immune system produces antibodies that bind to AChR, which activates the complement cascade, another part of the immune system that leads to localized destruction of the neuromuscular junction (‘NMJ) by the deposition of terminal complement complex (‘TCC) C5b-9. Soliris is designed to block this deposition by binding to and inhibiting the cleavage of the C5 protein, an essential step at the start of the cascade.

The phase 3 REGAIN trial of soliris in patients with gMG did not achieve the primary endpoint of change in MG-ADL score, but it showed “clinically meaningful reduction in disease severity in treated patients.” However, patients treated with Soliris are at risk of meningococcal infections, which if not recognized and treated early, may rapidly become life-threatening or fatal.

Obviously, efgartigimod’s trial has seen comparatively better success. I do not wish to emphasize this point too strongly, not having compared the trial design, patient population and so on. However, efgartigimod is surely no pushover.

So, in the competition, on the one hand, we have efgartigimod’s success, novel MoA, broader application base potential, and proven ability to improve therapeutic effect in combination. On the other hand, we have Soliris’ almost legendary success in various indications, ALXN’s ability to bring to bear a lot of corporate strength to the market, and the competition is going to look very interesting. Not only so, there are various other up and coming molecules targeting gMG, so this is going to become a crowded space; good for patients, not so good for drug developers.

Bottomline for ARGX

I have always been bullish on ARGX, right since my first article in 2017 which brought this company to the attention of some investors. Despite its immense rise in the last 3 years - more than 10-fold, in fact - I still think there’s upside to the stock, given their immense R&D prowess. This is a stock to accumulate at dips, and hold on to for the long run.
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piddybull
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Re: Argen-X

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Argenx

The Argonauts were able to achieve the unthinkable.


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