DeBeurs.nl

Terra2000 2 november 2016 13:03

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Iemand een idee waarom het aandeel vandaag ineens wel sterk kan stijgen, meer dan 5%. Op de site zie ik geen aanleiding.

[verwijderd] 3 november 2016 13:22

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quote:
Terra2000 schreef op 2 november 2016 13:03:
Iemand een idee waarom het aandeel vandaag ineens wel sterk kan stijgen, meer dan 5%. Op de site zie ik geen aanleiding.

Zo mag het van mij nog wel een paar weken verder gaan.

[verwijderd] 3 november 2016 14:22

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Op het forum van Genfit staat dat dit bedrijf na het succes van de recente kapitaalsverhoging extra middelen heeft om zijn strategie te financieren. Met name de verdere ontwikkeling van het klinische fase III programma van Elafibraor, het vlaggenschip in NASH. De resultaten van dit onderzoek worden verwacht eind 2018. Als ze positief zijn kan Genfit een voorwaardelijke vergunning krijgen eind 2019 of begin 2020. CM-CIC analisten zien een zeer belangrijke marktkans als het bedrijf de verschillende fasen met succes passeert. Aangenomen wordt dat het Elafibranor proces een 100% kans op succes wordt en dat het in 2020 op € 207,00 zal staan, een vertienvoudiging.

Do not shoot the pianist....

TraderRon 3 november 2016 14:33

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If successful, CM - CIC Securities see #Genfit €207 by 2020.
Over rendement gesproken :)

TraderRon 4 november 2016 09:00

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Genfit FDA cleared IND to proceed with Phase II trial and evaluate elafibranor in PBC

Goed nieuws!

TraderRon 4 november 2016 09:16

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Intercept (ICPT) Moeilijkheidsgraad: GENFIT om ervan te genieten?
Geplaatst op 4 november 2016 door Schrijven BiotechBourse © in Nieuws , Producten

De belangrijkste concurrent van GENFIT, dat is de meest geavanceerde in de race voor de behandeling van NASH, werd onlangs zwaar gestraft: zijn cursus is meer dan 40% verloren in vijf weken gisteren het indrukken van de $ 100 is het laagste niveau sinds medio -februari 2016. Deze situatie is des te verontrustender dat makelaars in waarde zijn gedaald.

biotechbourse.fr/intercept-icpt-diffi...

TraderRon 4 november 2016 09:37

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GENFIT: FDA has officially cleared the IND to proceed with
Phase II trial and evaluate elafibranor in PBC

› Investigational New Drug (IND) application cleared by the FDA for the new
indication of elafibranor in Primary Biliary Cholangitis (PBC), a rare disease with
unmet need and only two orphan products approved to date
Lille (France), Cambridge (Massachusetts, United States), November 4, 2016 – GENFIT
(Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical company at the forefront of
developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that
notably affect the liver or the gastrointestinal system, today announced that the FDA has cleared
the IND to proceed with the Phase II trial aimed at evaluating elafibranor in PBC.
As previously announced, this trial is designed to be a multicenter, double-blind, randomized,
placebo-controlled, Phase II study to evaluate the efficacy and safety of elafibranor after 12 weeks
of treatment in patients with PBC and inadequate response to ursodeoxycholic acid.
The primary objective is to determine the effect of daily oral administration of elafibranor on serum
alkaline phosphatase (ALP) in these patients, based on relative change versus placebo.
Secondary endpoints will include:
? ALP < 1.67 × upper limit of normal (ULN) and total bilirubin within normal limit and > 15%
decrease in ALP
? Paris, Toronto, UK PBC scores
? Pruritus and QoL (Quality of Life)
? Safety of elafibranor in a PBC population
PBC is a rare disease with unmet need. Current treatments only cure a fraction of the patient
population, and/or generate important side effects such as pruritus, which is a major and wellknown
symptom already affecting most PBC patients.
Jean-François Mouney, CEO, Co-founder, and Chairman of the board of GENFIT
commented: “We are satisfied with the progress made on the regulatory side in PBC. Our presence
in this field is highly relevant given the profile of elafibranor, our proprietary molecule. We soon
hope to be able to provide patients with a new, safe and well-tolerated therapeutic solution. Our
involvement in PBC will continue to enrich our medical network thanks to our broad discussions and
interactions we have with hepatologists. We value and cultivate a high level of collaboration with
the medical community as it’s a way for us to ensure that the best decisions are made to address
unmet medical needs in this field.”

www.genfit.fr/wp-content/uploads/2016...

Engels wat beter te lezen ;)

[verwijderd] 4 november 2016 09:59

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quote:
TraderRon schreef op 4 november 2016 09:37:
Engels wat beter te lezen ;)

LIKE

[verwijderd] 4 november 2016 12:01

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A study on Elafibranor in PBC is planned to start H2 2016

Volgend deel van de puzzel is ingevuld, en mooi volgens planning!
Vol vertrouwen de toekomst in!

[verwijderd] 6 november 2016 13:01

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quote:
JOVRO schreef op 2 november 2016 10:30:
Phase 1 and preclinical

studies on on RoR Gamma T are planned H1 2017

Phase 2

A study on Elafibranor in PBC is planned to start H2 2016

A study on Elafibranor in Pediatric NASH is planned to start H2 2016

A study on Enafibranor in liver cirrhosis is planned H1 2017

einde fase 3 Elafibranor-Nash is in 2019 als ik me niet vergis

De fase 3 duurt nog ruim 2 jaar en het valt dan te hopen dat de uitkomst positief is en niet zoals fase 2 nogal mistig is anders krijg je weer een lange tijd van onzekerheid en misschien nog jarenlange vervolgonderzoeken

Het grootste probleem bij NASH is dat het in een groot aantal gevallen een welvaartskwaal (verkeerde eetgewoontes en te weinig beweging) is en niet echt een ziekte

Een middel die genfit aan het ontwikkelen is om deze ziekte (natuurlijke aanleg en erfelijkheid) in een vroegtijdig stadium te kunnen opsporen zie ik veel toekomst Men kan dan in een groot aantal gevallen volstaan met een aangepast dieet met als het nodig is een medicijn die oa leverfibrose voorkomt en op langere tijd bepaalde vormen van kanker ,het is wel de vraag hoe groot deze groep is

Er zijn op dit moment veel bedrijven actief om een medicijn te ontwikkelen tegen NASH en ontstekingsziektes (fibrose) Gilead ,Galapagos Abbvie en nog vele anderen timmeren flink aan de weg We zullen moeten afwachten wie (kunnen er meer zijn)met de beste medicijn uit de bus zal komen

[verwijderd] 7 november 2016 13:01

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www.lerevenu.com/placements/economie/...

TraderRon 8 november 2016 09:31

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GENFIT : THIRD QUARTER 2016 FINANCIAL information
(Unaudited financial information in accordance with IFRS)

Cash and cash equivalents of €84.86 million as at September 30, 2016

Capital increases of a total gross amount of €78.5 million carried out successfully in October and November 2016

Revenues for first nine months of 2016 of €0.22 million

Lille (France), Cambridge (Massachusetts, United States), November 8, 2016 - GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announced its cash and cash equivalents as at September 30, 2016 and its revenues for the first nine months of 2016.

Cash position
As at September 30, 2016, the Company's cash and cash equivalents ("Cash") amounted to €84.86 million compared with €64.32 million for the same period in 2015.

Thereafter in early October 2016, GENFIT carried out a capital increase by way of a private placement, followed by, at the beginning of November 2016, a rights issue, which allowed the Company to raised a total gross amount of €78.5 million.

The net proceeds of these two capital increases are thus added to the €84.86 in Cash as at September 30, 2016.

Revenues
Revenues for the first nine months of 2016 amount to €0.22 million compared to €0.45 million for the same period in 2015.

Significant events of the third quarter 2016
Regarding elafibranor, the third quarter was marked by the filing of an IND (Investigational New Drug) for a Phase 2 trial in a new indication, Primary Biliary Cholangitis (PBC). The FDA has since approved this IND.

In the framework of its program for the discovery and development of biomarkers in NASH, the Company also announced the launch of a large-scale qualification program of its proprietary non-invasive diagnostic based on miRNAs for the identification of NASH patients to be treated; the validation, with an independent cohort, of miRNAs discovered in the second half 2015; and the discovery of a new set of highly predictive miRNAs.

Finally, in relation to the Company's TGFTX1 program, the Company identified several new RORgt inverse agonists as drug candidates for regulatory pre-IND studies.

Upcoming event: AASLD Annual Meeting ("The Liver Meeting", Boston, November 11-15, 2016)

The AASLD selected five GENFIT abstracts that will highlight post-hoc analyses of the GOLDEN-505 Phase 2 trial, the potential of non-invasive biomarkers identified by GENFIT to improve the identification of NASH patients to be treated, novel results of rodent NASH models compared with human NASH, and the importance of treating the histological parameters of NASH, and more precisely necro-inflammation, in the regression of fibrosis.

On this occasion, GENFIT will host three events:

An analyst and investor event, with the participation of four internationally-renowned experts,
A scientific advisory board dedicated to biomarkers in NASH, and
A scientific advisory board on fibrosis.

About Elafibranor:

Elafibranor is GENFIT's lead pipeline product. Elafibranor is an oral once-daily treatment, and a first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH). Elafibranor is believed to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers.

About NASH:

"NASH", or nonalcoholic steatohepatitis, is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer.

About PBC:

"PBC" or Primary Biliary Cholangitis, is a chronic disease in which bile ducts in the liver are gradually destroyed. The damage to bile ducts can inhibit the liver's ability to rid the body of toxins, and can lead to scarring of liver tissue known as cirrhosis.

About GENFIT:

GENFIT is a biopharmaceutical company focused on the discovery and development of drug candidates in areas of high unmet medical needs corresponding to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT's R&D efforts are focused on bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH - Nonalcoholic steatohepatitis) and more generally the gastro-intestinal arena. GENFIT's approach combines novel treatments and biomarkers. Its lead proprietary compound, Elafibranor, is currently in a Phase 3 study. With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 110 employees. GENFIT is a public company listed in compartment B of Euronext's regulated market in Paris (Euronext: GNFT - ISIN: FR0004163111). www.genfit.com

www.holdthepresses.eu/2016/11/genfit-...

[verwijderd] 9 november 2016 16:29

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Beursblik: verkoopgolf zal van korte duur zijn
Republikeinen zorgen waarschijnlijk voor nieuw groeiplan.
(ABM FN) De markten zullen herstellen steunend op het vertrouwen in een nieuw groeiplan van de Republikeinen. Dit stelde martkstrateeg David Bianco van Deutsche Bank woensdag naar aanleiding van de overwinning van Donald Trump in een rapport gericht aan klanten.
"We denken dat de boodschap van deze verkiezing de Amerikaanse eis naar een sterkere economische groei is. Een Republikeins Congres en president zullen waarschijnlijk de regelgeving verminderen en de vennootschapsbelasting genoeg verlagen om aan concurrentiekracht te winnen en geld uit het buitenland terug te brengen", stelde Bianco.
Volgens de analist is deze ommezwaai naar Republikeins terrein goed voor de markten. Een verkoopgolf zal volgens hem dan ook van korte duur zijn en vooral farmabedrijven zullen het goed doen.
Door: ABM Financial News.
pers@abmfn.be
Redactie: +32(0)78 486 481
Copyright ABM Financial News. All rights reserved
(END) Dow Jones Newswires
November 09, 2016 09:51 ET (14:51 GMT)

[verwijderd] 15 november 2016 10:53

1

seekingalpha.com/author/logribel-bios...

Interessant inzake genfits NASH potentieel

[verwijderd] 2 december 2016 10:02

1

NASH is a promising market, since the disease already affects 6 to 15 million people in the U.S. and unfortunately, the number is estimated to grow over time because of the trend in obesity and bad eating habits. To make a comparison, the number of people living with HCV in 2009 (before Gilead's blockbuster drugs) was estimated to be around 3.2 million. In financial terms, Deutsche Bank estimated that the market will be worth between $35 and $40 Billion by 2025. While there are no treatments for NASH at the moment, many companies can see the market potential. Genfit (OTCPK:GNFTF), Galmed (NASDAQ:GLMD), Intercept (NASDAQ:ICPT) and Novo Nordisk (NYSE:NVO) are trying to develop treatments and even the giant of dermatology Allergan (NYSE:AGN) has recently entered the market through the acquisition of Tobira Therapeutics (NASDAQ:TBRA) and Akarna.

[verwijderd] 2 december 2016 10:29

1

quote:
Brouya schreef op 2 december 2016 10:02:
NASH is a promising market, since the disease already affects 6 to 15 million people in the U.S. and unfortunately, the number is estimated to grow over time because of the trend in obesity and bad eating habits. To make a comparison, the number of people living with HCV in 2009 (before Gilead's blockbuster drugs) was estimated to be around 3.2 million. In financial terms, Deutsche Bank estimated that the market will be worth between $35 and $40 Billion by 2025. While there are no treatments for NASH at the moment, many companies can see the market potential. Genfit (OTCPK:GNFTF), Galmed (NASDAQ:GLMD), Intercept (NASDAQ:ICPT) and Novo Nordisk (NYSE:NVO) are trying to develop treatments and even the giant of dermatology Allergan (NYSE:AGN) has recently entered the market through the acquisition of Tobira Therapeutics (NASDAQ:TBRA) and Akarna.

Dit is ook nog een artikel..met ongeveer zelfde strekking:

decisionresourcesgroup.com/drg-blog/n...

Terra2000 2 december 2016 20:00

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Dank speurneus voor de link. ik kende het artikel niet. positief nieuws is altijd welkom.

TraderRon 6 december 2016 08:35

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Dit kan nog leuk worden!!!!
French Drugmaker Genfit Said to Explore Options Including Sale
by Manuel Baigorri and Dinesh Nair
December 5, 2016 — 1:56 PM EST December 5, 2016 — 1:56 PM EST
Genfit said to work with advisers, also consider partnerships
NASH treatment maker said in talks with other drug companies
French drugmaker Genfit is working with advisers to explore options, including a sale of the business, as its treatment for a type of liver disease linked to obesity attracts interest from other pharmaceutical companies, according to people familiar with the matter.

The company, which is developing a drug for nonalcoholic steatohepatitis or NASH, is also weighing licensing agreements, partnerships or joint ventures, one of the people said, asking not to be identified as the considerations are private. The company is in early discussions with other drugmakers, though the talks may not lead to a deal, the person said. Genfit shares have declined 38 percent this year, giving it a market value of about $654 million.

A spokesman for Genfit declined to comment.

Pharmaceutical companies including Sanofi, Novartis AG and Shire Plc may be interested in Genfit, people familiar with the matter said last year. Genfit is developing a drug called elafibranor, and in October raised about 78.5 million euros ($84.6 million) to continue to fund the product.

So far, no treatments have been approved to treat NASH, which is a slow developing disease that occurs when fat accumulates in the liver, causing inflammation and damage. The condition may ultimately lead to cirrhosis. It will be the leading cause of liver transplants by 2020, according to Allergan Plc, which has been acquiring companies developing treatments this year. More than 12 percent of adults in the U.S. may have the condition, according to Genfit.
A number of other companies are also racing to develop treatments for the disease, including Intercept Pharmaceuticals Inc. and Gilead Sciences Inc.

www.bloomberg.com/news/articles/2016-...

DeZwarteRidder 6 december 2016 08:51

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Als dit klopt, dan zien ze heil meer in hun NASH-middel.
Het zou een overname uit armoe zijn.

[verwijderd] 6 december 2016 08:58

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quote:
DeZwarteRidder schreef op 6 december 2016 08:51:
Als dit klopt, dan zien ze heil meer in hun NASH-middel.
Het zou een overname uit armoe zijn.

je bedoelt geen heil meer....

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