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arGEN-X Nieuws 2017

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quote:

fly like an eagle schreef op 14 april 2017 09:37:

Is toch weer mooi 10 M cash in
Zeker

Nog mooier de ontwikkeling in immunotherapie . de toekomst

Argen-X nog steeds zwaar ondergewaardeerd .
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Dutch drugmaker Argenx (OTC:ARGNF) has filed for a U.S. initial public offering of up to $74.8M.

Gaat zeker helpen
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Published: 07:00 CEST 24-04-2017 /GlobeNewswire /Source: argenx N.V. / : ARGX /ISIN: NL0010832176

argenx files registration statement for a proposed public offering in the United States



24 April 2017



Breda, the Netherlands / Ghent, Belgium - argenx N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced that it filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission for a proposed public offering in the United States of its American Depositary Shares (ADSs) representing ordinary shares. All ADSs to be sold in the offering will be offered by argenx. The offering is subject to market and other conditions, including the effectiveness of the above-referenced registration statement. argenx's ordinary shares are currently listed on Euronext Brussels and argenx has made an application to have its ADSs listed on the NASDAQ Stock Market under the symbol "ARGX".



Cowen and Company and Piper Jaffray & Co. are acting as joint bookrunning managers for the proposed offering, and JMP Securities and Wedbush PacGrow are acting as co-managers. Kempen & Co is acting as argenx's advisor in connection with the proposed offering.



The securities referred to in this release are to be offered only by means of a prospectus. When available, copies of the preliminary prospectus can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (631) 274-2806 or by fax at (631) 254-7140 or from Piper Jaffray & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55403, or by telephone at (800)747-3924, or by email at prospectus@pjc.com.



A registration statement relating to and describing the terms of the offering has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.



About argenx

argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.







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Argenx IPO: A Biotech Turnaround?

Apr. 25, 2017 4:37 PM ET| About: Argen X NV (ARGNF)
Richard Ashton
Richard Ashton
Growth, long/short equity, insider ownership, tech

(119 followers)
Summary

Dutch biotech firm Argenx N.V. has filed for an IPO worth about $75 million but has not released details on share pricing.

Argenx is developing antibody platforms and drugs based on the llama immune system and has multiple drugs in Phase 2 clinical trials.

Argenx has partnerships with major pharmaceutical companies like Shire, which holds about 12 percent of the company’s stock.

Investing in biotech IPO is riskier in general, but Argenx is a good bet if you really want to invest in this field.

The biotech IPO market, like IPOs in general, have undergone a renaissance as the markets have improved and companies start moving away from private investors. As Pharmaphorum notes, a series of biotech companies have filed to go public over the last month, including Ovid Therapeutics (Pending:OVID) and Biohaven Pharmaceuticals.

Now investors need to add Argenx N.V. to the list. This Dutch biotech firm has released further details on its upcoming IPO as it announced that it plans to raise up to nearly $75 million in its IPO on the NASDAQ. However, Argenx has not revealed how many shares nor what the pricing will be to reach that $75 million.

Biotech companies remain a highly risky endeavor, and Argenx is no exception. However, there are certain things to like in this company's pipeline as it has multiple drugs in or near Phase 2, good partners, and is taking an innovative approach towards fighting crucial diseases. Investors with a higher tolerance for risk should consider Argenx. However, remember that while the biotech market has improved compared to 2016, it is still not fully recovered from the down years.

The Power of Llamas

If there is anything which can be said about Argenx, it is that it has certainly taken a unique approach towards fighting diseases. In Argenx's own words in its SEC filing, the company plans to treat severe autoimmune diseases and cancer with a SIMPLE antibody platform "based on the powerful llama immune system." Yes, you read that right. Llamas.

But this is no joke, as pharmaceutical and biotech companies have been looking at the potential of the llama immune system for years. Argenx argues that its llama antibody platform is more diverse than antibody platforms developed in mice or synthetic systems, and has created multiple drugs along this platform.

Argenx's most important drugs are ARGX-113, which would be designed to fight rare autoimmune diseases, and ARGX-110, which would be fighting T-cell lymphoma and acute myeloid leukemia. Both of these drugs recently entered Phase 2 testing with the FDA, and Argenx has other drugs on the market including partnerships with other medical companies to fight less critical but still widespread conditions like arthritis and skin inflammation.

All of this is generally good signs for investors. Argenx has multiple drugs in Phase 2 testing, it is has partners who are interested in its products, and it is testing a wide variety of drugs which would all be in demand. But the fact that both ARGX-113 and ARGX-110 entered Phase 2 in March and April 2017 respectively does mean that investors will be waiting quite a while, praying for positive results and investing in a company for which there is currently almost no Phase 2 data.

Low Debt and Partnerships

Investors should be concerned about how long it will take for data to come out and Argenx to develop ARGX-113 and ARGX-110, but the company overall has strong fundamentals. While Argenx of course lost money as every rising biotech company does, it has over €100 million in financial assets compared to a carrying amount of €12 million in financial liabilities.

In addition, Argenx has been able to secure important partnerships, particularly one with Shire Pharmaceuticals. Shire invested $20 million in Argenx in 2014 and announced an extension of this strategic alliance in February. When one considers how Argenx has been able to secure valuable partners, it is clear that medical experts and companies believe that Argenx is developing something useful and profitable.

Risk and Reward

Investing in biotech is almost always a risky endeavor and Argenx is no exception. Its main drugs have just entered Phase 2 testing and will not be ready for years, and there is obviously no way to know if they will sell even if they are approved by the FDA.

But Argenx has plenty of assets, is aggressively pushing drugs which should be able to gain a lucrative market, and has major partners like Shire which will let it both earn money through royalties and also strike out on its own. And by going public in a friendlier but still somewhat depressed biotech IPO market, Argenx should be able to attract interest.

More cautious investors should probably stay away from biotech IPOs in general, but a more aggressive investor could make a great deal down the line with Argenx. Do remember to be patient as it will take time to reap any potential rewards.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Pokerface
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argenx reports first quarter 2017 financial results and provides business update

2 May 2017

Breda, the Netherlands/Ghent, Belgium argenx (Euronext Brussels: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced financial results and provided a business update for the first quarter ended March 31, 2017.

"We are pleased with our pipeline progress this past quarter having launched two clinical studies across our lead programs, as we set out to do at the start of the year. This leaves us very well-positioned with one ongoing Phase 1/2 and three Phase 2 trials to have several potential value creating events for the Company over the next year. Additionally, we have continued this quarter to expand our Innovative Access Program with new partnered programs with Broteio Pharma and Staten Biotechnology targeting severe autoimmune diseases and dyslipidemia and to validate our strategic collaborations with the extension of our Shire collaboration and our AbbVie partnership, through which we will receive our first preclinical milestone payment. These collaborations remain crucial to our goal of maximizing our pipeline value," commented Tim Van Hauwermeiren, CEO of argenx.

FIRST QUARTER 2017 AND RECENT HIGHLIGHTS

Dosed first patients with ARGX-113 in two Phase 2 proof-of-concept studies for treatment of primary immune thrombocytopenia (ITP) and myasthenia gravis (MG).
Launched Phase 2 study of ARGX-110 as a monotherapy in relapsed/refractory cutaneous T-cell lymphoma (CTCL) patients. This follows the initiation of a Phase 1/2 study of ARGX-110 in combination with azacitidine in newly diagnosed acute myeloid leukemia (AML) patients in December 2016.
Announced that Staten Biotechnology exercised its exclusive option to license ARGX-116, an anti-ApoC3 SIMPLE AntibodyTM with therapeutic potential in dyslipidemia. This collaboration stems from our Innovative Access Program.
Announced collaboration with Broteio Pharma to develop therapeutic antibody for severe autoimmune diseases, representing the latest success for our Innovative Access Program.
Announced in April the first of two expected preclinical milestone payments from AbbVie collaboration before its filing of an investigational new drug (IND) application for ARGX-115, triggering a $10 million payment.
Continued collaboration with Shire AG to discover and develop novel human therapeutic antibodies to address diverse rare and unmet diseases. Our strategic partnership with Shire was extended for a further year until May 30, 2018.
Filed registration statement for a proposed public offering in the United States.
Announced that Dr. J de Koning and E. Castaldi, who remains the CFO of argenx, have resigned from the Board of Directors and Msc. A.A. Rosenberg was appointed to the Board of Directors.


UPCOMING CLINICAL MILESTONES

ARGX-113

Topline data from Phase 2 study in MG expected in 1Q 2018 and ITP expected in 2H 2018.
Initiation of Phase 1 clinical trial of subcutaneous dosing in healthy volunteers expected in 2H 2017.


ARGX-110

Interim data from Phase 1/2 study in AML and Phase 2 study in CTCL each expected by the end of 2017 and topline data from Phase 2 study in CTCL expected by the end of 2018.

ARGX-111

Safety endpoints were met in the Phase 1 clinical trial; complete data set to be presented at the American Society of Clinical Oncology (ASCO) conference (Singapore) in July 2017.


FINANCIAL HIGHLIGHTS (as on March 31, 2017) (compared to financial highlights as of March 31, 2016)

Operating income of €7.2 million (March 31, 2016: €2.8 million).
Total comprehensive loss of €8.4 million (March 31, 2016: €3.0 million).
Cash position of €85.0 million (cash, cash-equivalents and current financial assets) (March 31, 2016: €53.8 million) allowing the Company to pursue development of its product portfolio in line with its communicated business plan.



KEY FIGURES (CONSOLIDATED AND UNAUDITED)


1Q ended
1Q ended

in thousands of euros
March 31,
2016
March 31, 2017
Variance








Revenue
2,216
6,659
4,443
Other operating income
619
552
(67)
Total operating income
2,835
7,211
4,376
Research and development expenses
(4,408)
(12,196)
(7,788)
General and administrative expenses
(1,401)
(3,411)
(2,010)
Operating loss
(2,974)
(8,396)
(5,422)
Financial income
42
(3)
(45)
Exchange gains/(losses)
(38)
(11)
27
Total comprehensive loss
(2,970)
(8,410)
(5,440)
Net increase (decrease) in cash, cash-equivalents
and current financial assets compared to year end 2015 & 2016
11,520
(11,752)
(23,272)
Cash, cash-equivalents and current financial assets
at the end of the period
53,847
84,977
31,130


DETAILS OF THE FINANCIAL RESULTS

For the three-month period ended March 31, 2017, operating income reached €7.2 million compared to €2.8 million during the three-month period ended March 31, 2016. The higher operating income in the three-month period ended March 31, 2017 is mainly due to the partial recognition of the upfront payment from the AbbVie collaboration announced in April 2016.

Research and development (R&D) expenses were €12.2 million for the three-month period ended March 31, 2017 and €4.4 million during the three-month period ended March 31, 2016. The €7.8 million increase in R&D expenses in the three-month period ended March 31, 2017 corresponds principally to increased clinical trial activities and to the recruitment of additional R&D personnel.

General and administrative (G&A) expenses amounted to €3.4 million for the three-month period ended March 31, 2017 and €1.4 million during the three-month period ended March 31, 2016. The €2.0 million increase in the three-month period ended March 31, 2017 is principally due to expenses related to the proposed public offering in the United States and the recruitment of additional G&A personnel for supporting the operational activities of the Company.

The Company generated a total comprehensive loss of €8.4 million for the three-month period ended March 31, 2017 compared to €3.0 million during the three-month period ended March 31, 2016.

The Company's cash, cash equivalents and current financial assets amounted to €85.0 million on March 31, 2017 compared to €96.7 million on December 31, 2016.
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Hele mooie cijfers .
Ik weet niet of het opvalt , maar er lijkt duidelijk een versnelling te zijn in het aantal nieuwe partnerships/ producten / ontwikkelingen ( voor zo jong bedrijf)
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Wat ik al schreef . Versnelling ! Super

Published: 07:00 CEST 04-05-2017 /GlobeNewswire /Source: argenx N.V. / : ARGX /ISIN: NL0010832176

argenx reaches 50% enrollment in Phase 2 clinical trial of ARGX-113 in myasthenia gravis



Top-line data from the study expected in first quarter of 2018


4 May 2017



Breda, the Netherlands / Ghent, Belgium - argenx (Euronext Brussels: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that it has recruited 50% of the myasthenia gravis (MG) patients in the Phase 2 proof-of-concept study of ARGX-113.



"We are encouraged by the pace of enrollment in this trial," commented Nicolas Leupin, Chief Medical Officer of argenx. "We now expect to present the top-line data of the ARGX-113 clinical trial in MG in the first quarter of 2018."



The double-blind, placebo controlled Phase 2 study is enrolling up to 24 MG patients with confirmed generalized muscle weakness. ARGX-113 is being dosed on top of current standard of care, including cholinesterase inhibitors, steroids and/or immunosuppressants. The primary objectives of the trial are safety and tolerability, and secondary objectives include efficacy and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers.



The MG clinical trial was launched in January of this year. ARGX-113 is also being studied in a Phase 2 proof-of-concept study for the treatment of primary immune thrombocytopenia, which was initiated in March 2017.



About ARGX-113

ARGX-113 is an investigational therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies.



About argenx

argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.

www.argenx.com



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Aandeel staat gewoon spotgoedkoop, omdat er totaal geen aandacht voor was .
Dat gaat nu veranderen . Lees alle bovenstaande persberichten maar eens goed door . Vele partnerships/ontwikkelingen / potentiële blockbusters .

Nu ook Ablynx nog even en ik ben dik tevreden . LT
KAKO
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quote:

bioscience schreef op 19 mei 2017 11:23:

Aandeel staat gewoon spotgoedkoop, omdat er totaal geen aandacht voor was .
Dat gaat nu veranderen . Lees alle bovenstaande persberichten maar eens goed door . Vele partnerships/ontwikkelingen / potentiële blockbusters .

Nu ook Ablynx nog even en ik ben dik tevreden . LT
Ik hoop het ook. Heb de helft van mijn Ablynx stukjes ingeruild voor extra Gala. Wacht al lang op Ablynx maar tot nu toe vooral teleurgesteld. Merus is trouwens ook de moeite waard om te volgen.
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Ja Merus nu onder de 20 terwijl Incyte recent er 25 USD voor betaald; zelfde scene alleen zetten in op bispecifieke antboides. Gala durf ik niet meer, want kan die hoge waarderingen niet goed inschatten, maar in verleden zeer mooi rendement mee gemaakt.
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fly like an eagle schreef op 19 mei 2017 11:55:

Ja Merus nu onder de 20 terwijl Incyte recent er 25 USD voor betaald; zelfde scene alleen zetten in op bispecifieke antboides. Gala durf ik niet meer, want kan die hoge waarderingen niet goed inschatten, maar in verleden zeer mooi rendement mee gemaakt.
Vwb Biotech zit ik zelf in Galapagos, ProqR, Genfit, Merus, Pharnext, ArgenX, MdxHealth, Biocartis en Kiadis.

- Galapagos: je zegt hoge waardering, afgezet tegen de riskantere biotechs die nog heel ver verwijderd zijn van een medicijn op de markt zie je dat bij Galapagos het risico lager wordt omdat mn Filgotinib heel ver in de testen is met niet alleen goede resultaten, zelfs best in class resultaten. Risico loopt eruit, koers loopt op

Daarnaast heb ik veel vertrouwen in mn Genfit, Merus, Proqr en ArgenX.
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Pl4 schreef op 19 mei 2017 12:09:

[...]

Vwb Biotech zit ik zelf in Galapagos, ProqR, Genfit, Merus, Pharnext, ArgenX, MdxHealth, Biocartis en Kiadis.

- Galapagos: je zegt hoge waardering, afgezet tegen de riskantere biotechs die nog heel ver verwijderd zijn van een medicijn op de markt zie je dat bij Galapagos het risico lager wordt omdat mn Filgotinib heel ver in de testen is met niet alleen goede resultaten, zelfs best in class resultaten. Risico loopt eruit, koers loopt op

Daarnaast heb ik veel vertrouwen in mn Genfit, Merus, Proqr en ArgenX.
Volgens mij vergeet je 1 zaak mbt Ablynx .
Ablynx zit veel dichter bij goedkeuring/ marktintroductie van een eerste medicijn dan GLPG . Al denk ik dat GLPG een grote toekomst tegemoet gaat staan ze wat koers tov Ablynx veel te hoog (tevens weet je niet wat fase 3 gaat doen) . Dat heeft te maken door dat de grote hoop (op dit moment)achter GLPG aan hobbelt en Ablynx (ook uiteraard door stomme fouten/lees contract met Abbvie)) in de vergetelheid is geraakt . Dit kan echter zeer snel bijtrekken .

Ik zet iig in op Ablynx / Argen-X en Thrombogenics . Alle 3 zeer laag gewaardeerd als we het afzetten tegenover pipeline en cash .
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Published: 15:00 CEST 19-05-2017 /GlobeNewswire /Source: argenx SE / : ARGX /ISIN: NL0010832176
argenx announces full exercise of underwriters' option to purchase additional ADSs

Regulated information - inside information





Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX) announced today that the underwriters of its initial public offering in the United States (the "Offering") have exercised their overallotment option to purchase 879,750 additional American Depositary Shares ("ADSs") in full. This option exercise brings the anticipated total gross proceeds from the Offering to approximately $114.7 million from the sale of an aggregate of 6,744,750 ADSs. Each of the ADSs offered represents the right to receive one ordinary share.

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