GENFIT - ALGFT - FR0004163111

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Soppi
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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

kenzo schreef:
16 jan 2020 13:30
Hoe groot denken jullie dat de kans op goedkeuring is en welke koers verwachten jullie bij goedkeuring?
Op het franse forum denkt men aan het Tobira scenario.
Hoor het graag

Allereerst maar wachten op de resultaten van de phase 3 testen!!

Hopelijk wordt door de aangepaste phase 3 setup het primaire eindpunt bereikt....

En zal de FDA de complementaire werking inzien van Elafibranor van Genfit enerzijds en OCA van Intercept Pharmaceuticals anderzijds ( Nash resolutie versus fibrosis) ....en kunnen beide producten goedgekeurd worden....

Tot slot
Met de marktkapitalisatie momenteel van minder dan 750 miljoen euro, acht ik de kans groot dat een grote pharma speler zoals Gilead een overnamebod zal doen op Genfit (bij positieve resultaten) met overname premie van minstens 80% van de huidige koers!

Ik ben een kleine 3 maand geleden ingestapt aan zo'n 13 euro.....en blijf voorlopig zitten...

De resultaten verwacht ik elk moment nu....en denk zelf voor eind Januari....



kenzo
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Re: GENFIT - ALGFT - FR0004163111

Bericht door kenzo »

Soppi schreef:
18 jan 2020 00:04
kenzo schreef:
16 jan 2020 13:30
Hoe groot denken jullie dat de kans op goedkeuring is en welke koers verwachten jullie bij goedkeuring?
Op het franse forum denkt men aan het Tobira scenario.
Hoor het graag

Allereerst maar wachten op de resultaten van de phase 3 testen!!

Hopelijk wordt door de aangepaste phase 3 setup het primaire eindpunt bereikt....

En zal de FDA de complementaire werking inzien van Elafibranor van Genfit enerzijds en OCA van Intercept Pharmaceuticals anderzijds ( Nash resolutie versus fibrosis) ....en kunnen beide producten goedgekeurd worden....

Tot slot
Met de marktkapitalisatie momenteel van minder dan 750 miljoen euro, acht ik de kans groot dat een grote pharma speler zoals Gilead een overnamebod zal doen op Genfit (bij positieve resultaten) met overname premie van minstens 80% van de huidige koers!

Ik ben een kleine 3 maand geleden ingestapt aan zo'n 13 euro.....en blijf voorlopig zitten...

De resultaten verwacht ik elk moment nu....en denk zelf voor eind Januari....
Bedankt voor de reactie Soppi!
Ik ben een heel stuk hoger ingestapt rond de 18,55.

Denk zelf ook dat Gilead mogelijk een bod kan doen na goedkeuring.
Waarom denkt u dat men minstens slechts 80% premie op de huidgie koers zal bieden.
Als dit het geval is kan ik beter verkopen... Risk/reward is dan heel slecht.

Zelf verwacht ik na goedkeuring al wel een stijging van minimaal 150%.
De Nash markt is gigantisch en zal alleen maar toenemen.

Positieve punten:
#Gigantische Nash markt
# First mover advantage
# Kans op overname heel groot
# Marketcap is slechts 750 miljoen
# Flinke stijging achter op fors volume ( vanaf december)


Negatieve punten:
Echter zijn er ook best veel zaken waar ik mijn vraagtekens bij zet:
# Trackrecord en niet nakomen van afspraken/ uitstellen resulaten
# Het vertrek van CEO,
# Bijna alle concurrenten zijn er niet in geslaagd, waarom Genfit wel?

Ben ook benieuwd of u de bovenstaande negatieve punten kunt weerleggen.
Waarom denkt u dat de resultaten op zeer korte termijn komen?
Ben eerder bang dat er weer uitstel komt.

Soppi
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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

Er blijven inderdaad vragen ...die ik niet onmiddellijk kan beantwoorden...(vertrek CEO, uitstellen resultaten, falen concurrenten, ...)


Aan de andere kant trek iik me op aan de volgend artikel ivm resultaten van Phase2b Golden....
Die na eerste lezing een negatieve schokgolf teweeg brachten (missen primair eindpunt).... maar bij analyse van subgroep zeer positief waren (eliminatie van minder zieke patiënten met NAS score <4 en eliminatie van kleiner centra)

Zie verduidelijking hieronder:


THE CLINICAL STUDY - 2B PHASE - « GOLDEN"

The study of Phase 2b was entitled GOLDEN with a duration of 52 weeks integrating Originally 270 patients, included three balanced arms, placebo, ELAFIBRANOR 80 mg / day and a ELAFIBRANOR to 120mg / day, all orally. GENFIT was the direct sponsor of this study.

At the end of March 2015 GENFIT announced the first results of this study, which were, in contrast to those of INTERCEPT very unwelcomed, the day after the announcement, GENFIT's share price lost 40% of its value.

THE RESULTS OF THE STUDY ARE PUBLISHED HERE

One cause of this stock disaster was, to my opinion, the shape and excessive honesty of the press on the results and concerted action market for stopping value.

The study included patients with GOLDEN NASH NAFLD with a score of 3 to 8 inclusive while studying Intercept excluded the NAS score <4. This inclusion, which had been validated by the FDA, these little ill patients played a trick on GENFIT. Indeed this small group of patients (15%) had the bad idea to heal all alone with placebo and lifestyle advocated in this type of study. Thus the statistical impact of these patients prevented GENFIT to have a statistically significant result in the entire study population. GENFIT, for honesty, has placed this point early in his press release, and this was immediately and opportunely announced by some as a complete failure of the study.

However, if the NAS score = 3 patients had sealed the statistical impact of the results, GENFIT had anticipated this possibility and had discussed with the FDA, even before the results of the study, statistical treatments used to rule a subpopulation if necessary.

This is common practice and regularly accepted, the only requirement being to validate statistical reprocessing prior to accessing data selections to avoid 'ad hoc' and 'post hoc' which could then be considered oriented data manipulation.

In the case of GENFIT two different data restatements were anticipated:

Remove patients with NAS < 4.
Remove the small unbalanced centers (with no patient in each arm) which is also a statistical standard that will be used to create a subset of the criteria of near future phase3. (this was not needed to reach the primary endpoint)
The mere withdrawal of NAS < 4 patients immediately exchange the results of the GOLDEN study, which then achieved its objectives with a statistically acceptable result.

Remove NAS patients with <4 is simply align with the population of INTERCEPT FLINT study had not included in its patient recruitment criteria with a NAS <4.

By removing these patients, it remains to GENFIT 74% of the initial study patients (compared with 71% remaining in the FLINT study of INTERCEPT because of his early stop). It is totally acceptable as a statistical basis and detractors of this method are not without ulterior motives.

The main end point of the GOLDEN trial was the reversion of NASH with no worsening of fibrosis.

On an identical population to the FLINT study, GOLDEN study GENFIT has succeeded in 52 weeks on this criterion (22.4% vs 12.7% GFT505 placebo, p = 0.046, RR = 1.9) when INTERCEPT had failed in 72 weeks on this identical criterion.

The results obtained are on the dose to 120 mg / day, the dose to 80 mg / day did not show any statistically sufficient effects, but the correlation of the two was able to demonstrate the dose / effect relationship of ELAFIBRANOR, this which is an essential factor in clinical studies and accepted a proof of the effectiveness of a drug.

The ELAFIBRANOR is significantly lower LDL and HDL levels up, it increases the sensitivity to insulin, and even if it does not show, the whole population, histological improvement of fibrosis , the set of metabolic markers of fibrosis is decreased sharply. According to experts, the 52 weeks of treatment were too short to hope for a significant reduction of fibrosis histologically, but the metabolic results make it possible to seriously consider a potential regression of fibrosis beyond 72 weeks.

A few days after the news release and when financial analysts were bent on value, a prominent scientist, a leader in the study of NASH, Professor Jean François Dufour, Switzerland, wrote in a tweet: « GFT505 which is a dual PPARα/δ agonist shows impressive results in phase 2b randomized controlled clinical trial »

It is a clear support of the Golden Study results by some of the major KOL on NASH in the world.

But the most important is that the phase IIb GOLDEN study, applying the new consensual definition of reversion accepted now by the FDA to the incoming Phases III, was a total success whithout any statistical retreatment of the patients ( it means on all the 273 patients of the study) and Elafibranor is the only drug reaching this endpoint.

19% vs 12% placebo on all the patients (NAS 3 included)
21% vs 11% placebo on NAS >=4
22% vs 12% placebo on NAS >=4 with fibrosis.
Ratziu V, Harrison S, Francque S, Bedossa P, Lehert P, Serfaty L, Romero- Gomez M, Boursier J, Abdelmalek M, Caldwell S, Drenth J, Anstee Q, Hum D, Hanf R, Roudot A, Megnien S, Staels B, Sanyal A, on behalf of the GOLDEN505 investigator study group, Elafibranor, an Agonist of the Peroxisome Proliferator-activated Receptor-α and -δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening, Gastroenterology (2016), doi: 10.1053/j.gastro.2016.01.038.

the conclusion of the article is :

"In conclusion, this randomized controlled trial provides evidence that pharmacological modulation of the PPARα/δ nuclear receptors results in substantial histological improvement in NASH, including resolution of steatohepatitis, and improvement of the cardiometabolic risk profile, with a favorable safety profile. Larger phase 3 trials of elafibranor in the target population of patients with moderate to severe NASH are warranted."



THE GOLDEN STUDY - 3 ARM SITE

GENFIT has therefore adapted its communication to demonstrate that the negative reading of his first statement had no place to be, for this, it relied on the opinions of KOL (Key opinion leader) in NASH, which were very positive

GENFIT published in April at EASL Congress further data on a smaller population comprising only major centers with a NAS> = 4.

In doing so they are close to the best of the future population and conditions for future Phase 3. The exclusion of small centers leads to a drastic reduction in the patient base which is reduced to 120 in this subgroup. It should be noted that this statistical treatment had been imagined before access to data and therefore does not involve an ad hoc population.

On this small subpopulation results are stunning:

The reversion of NASH no worsening of fibrosis (29% GFT505 vs 5% placebo, p = 0.001) or 5.8 times better than placebo (odds score)

And to compare with the study of INTERCEPT FLINT, decreased 2 points NAS score with no worsening of fibrosis (48% versus 21% GFT505 for placebo; p = 0.02) or 2.29 times better than placebo.



TRIALS IN COURSE AND PLANNED
The design of the ELAFIBRANOR Phase 3 in NASH was announced by GENFIT the November 16th, 2015 after obtaining the approval from the FDA and EMA. and published on clinicaltrials.org the 10 of March 2016

This is an extremely favorable design GENFIT for several reasons as it accompanies the new consensus definition of NASH.

the recruitment asked for the GENFIT’s subpart H (1000) is lower than the ICPT’one (1400)

I mentioned this evolution of the definition of NASH in my previous articles citing the symposium speakers on NASH, which was held last June in Paris.

A world expert questioned what defined him best the NASH answered "the balloning and portal inflammation".

I recalled that on these two points, GENFIT announced very good results while the OCA Intercept had an efficiency almost zero on the balloning.

the design of the study announced is :

A total number of patients will be 1800 in total and two arms (the final design published refer to 2000 patients)

An arm 120 mg / day elafibranor
A placebo arm
What is interesting is that GENFIT has obtained eligibility for Subpart H on the basis of an interim study of 900 (1000 now) patients over 72 weeks only.

One histological criteria, the reversion of the NASH with no worsening of fibrosis.

But it is a new definition of reversion criteria:

A balloning score of 0
Inflammation score between 0 and 1
This design is incredibly favorable for GENFIT

The relative small size of the sample means will drastically limit the cost of this first phase of part 3 before applying for a marketing authorization and therefore to start returning cash.

It is far from the $ 200 million initially announced, if one follows the current design statistical publications of this type, the Phase 3 cost should not exceed a total of $ 150 million and may be only $ 80 million for the first phase which would consistent with a cost assessable to 5 times the cost of Phase 2b which included 270 patients for 12 months.

The second point is the histological criterion which is cut exactly on the known performance of the ELAFIBRANOR (an important action on the balloning and inflammation) and which deviates steatosis as a criterion on which the elafibranor was iless efficient.

Regarding GOLDEN study on ELAFIBRANOR

« Compared to PLB, the 120 mg arm improved ballooning (45% vs. 23%, p=0.02),

inflammation (55% vs. 33%, p=0.05) and steatosis (35.5% vs. 18%, NS) »

It is interesting to see that the results are in line with the new consensual definition of reversion ( good results in inflammation and balloning, NS in steatosis

With the new consensual definition of NASH, the GOLDEN study show significant results on reversion of NASH on the overall studied population (NAS 3 included)

Elafibranor 19% vs 12% p = 0.045 placebo



Professor Arun Sanyal, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, VA, commented: “The Phase 2b GOLDEN-505 study demonstrated that, in patients with clearly established NASH with high disease activity, Elafibranor safely led to resolution of steatohepatitis as well as improvement in cardiometabolic risk factors. Of particular importance is the efficacy of Elafibranor on the new consensual definition of resolution of NASH without worsening of fibrosis. Using this new consensual definition which emphasizes the role of cell injury and inflammation as the main drivers of fibrosis evolution, the GOLDEN-505 trial demonstrated that Elafibranor-treated patients who cleared their NASH also experienced a significant reduction in liver fibrosis. Thus, the design of the Phase 3 trial is optimal to confirm the good efficacy/safety ratio of Elafibranor on resolution of NASH at an interim analysis after 72 weeks, and on prevention of cirrhosis in the long-term.”

Volledig artikel:

http://www.nashbiotechs.com/drugs_en/ELAFIBRANOR.php

Soppi
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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

Wat ook zeer zeker in het voordeel is van Genfit zijn de sterke tussentijdse resultaten ivm Safety....
In tegenstelling tot sommige andere concurrenten (bvb Intercept) zijn er geen veiligheidsproblemen vastgesteld!

Bij positieve resultaten springt het aandeel meteen 10tallen percenten omhoog (kan gemakkelijk verdubbelen)....en een paar weken later een overname door Gilead of andere grote pharma speler met 80% overname premie daarbovenop.

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Re: GENFIT - ALGFT - FR0004163111

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Flinke solden, wat bijgekocht, benieuwd komende weken 8-)
Innate Pharma, Acacia pharma, QG, lysogene

kenzo
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Re: GENFIT - ALGFT - FR0004163111

Bericht door kenzo »

Is er nieuws?

Soppi
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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

Neen.....
Geen nieuws...
Zie onderstaande artikel waarin Genfit enkele ongefundeerde speculaties tegen spreekt...


Genfit réagit aux spéculations "infondées"

Genfit abandonne 5,5% désormais ce jeudi à 16,86 euros dans un volume épais représentant près de 3% du capital échangé. Le titre a connu une faiblesse à 15,15 euros en séance, en retrait de plus de 15% ! Face à ce mouvement brutal, le groupe a tenu à réagir dans une note adressée à ses investisseurs. La société biopharmaceutique de phase avancée, focalisée sur la découverte et le développement de solutions thérapeutiques et diagnostiques innovantes dans le domaine des maladies du foie, notamment d'origine métabolique, réagit donc aujourd'hui à "des spéculations infondées", selon le message adressé aux actionnaires.

"En réponse à l'inquiétude de certains investisseurs due aux volumes d'échange inhabituels du titre de la Société sur le marché et aux rumeurs infondées circulant sur plusieurs canaux ce jour, Genfit indique que l'essai clinique RESOLVE-IT progresse comme prévu". Genfit confirme par ailleurs que les premiers résultats intermédiaires de la Phase 3 RESOLVE-IT ne sont pas connus à ce jour, et qu'ils seront publiés, comme précédemment annoncé, avant la fin du premier trimestre 2020. Il n'y a à ce stade "aucune autre information matérielle à communiquer à propos de la Société", conclut Genfit.


https://www.boursedirect.fr/fr/actualit ... YW4zRVAwRg..

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Re: GENFIT - ALGFT - FR0004163111

Bericht door Marbull »

Intraday verkocht boven 17, terug in aan 15,3 en terug uit 17,47...mooi ritjes....
Innate Pharma, Acacia pharma, QG, lysogene

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Re: GENFIT - ALGFT - FR0004163111

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https://rivertonroll.com/news/2020/02/0 ... dated.html

GENFIT S A/ADR (NASDAQ:GNFT) Given Average Recommendation of “Buy” by Analysts
Posted by William Tyler on Feb 6th, 2020
GENFIT S A/ADR logoGENFIT S A/ADR (NASDAQ:GNFT) has earned a consensus rating of “Buy” from the nine brokerages that are presently covering the firm, MarketBeat reports. Three equities research analysts have rated the stock with a hold rating and six have issued a buy rating on the company. The average 12-month price objective among brokerages that have issued ratings on the stock in the last year is $45.37.

Several analysts have recently issued reports on the stock. HC Wainwright lowered their price target on shares of GENFIT S A/ADR from $72.00 to $58.00 and set a “buy” rating on the stock in a research report on Thursday, October 31st. Zacks Investment Research lowered shares of GENFIT S A/ADR from a “buy” rating to a “hold” rating in a research report on Monday. Svb Leerink reissued an “outperform” rating on shares of GENFIT S A/ADR in a research report on Thursday, January 2nd. Finally, B. Riley reissued a “buy” rating and issued a $43.00 price target on shares of GENFIT S A/ADR in a research report on Tuesday, November 26th.
Innate Pharma, Acacia pharma, QG, lysogene

Soppi
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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

GENFIT : levée d’aveugle des données de la Phase 3 RESOLVE-IT différée

GENFIT : levée d’aveugle des données de la

Phase 3 RESOLVE-IT différée



Lille (France), Cambridge (Massachusetts, États-Unis), le 20 février 2020 – GENFIT (Euronext : GNFT - ISIN : FR0004163111), société biopharmaceutique de phase avancée focalisée sur la découverte et le développement de solutions thérapeutiques et diagnostiques innovantes dans le domaine des maladies du foie, notamment d’origine métabolique, annonce aujourd’hui que la levée d’aveugle des données de sa Phase 3 RESOLVE-IT sera différée de manière à incorporer les derniers commentaires de la FDA attendus à la fin du mois de mars. Les principaux résultats intermédiaires seront annoncés dans les semaines suivant la réception de ces commentaires.

Cette décision a été prise dans le but d’appréhender au mieux l’état actuel de la réflexion au sein de l’écosystème NASH, pour que la Société puisse optimiser le dossier de NDA d’elafibranor au moment de sa soumission.

A ce stade, l’essai clinique reste en double aveugle, ce qui signifie que ce délai n’est en aucun cas lié à :

Une question d’efficacité d’elafibranor ;
Une question de tolérabilité ou de sécurité d’emploi d’elafibranor ;
Un sujet d’ordre corporate, légal, stratégique ou financier.
La visite finale du dernier patient de la cohorte destinée à obtenir l’approbation accélérée de mise sur le marché a été réalisée dans les temps, et la base de données de l’essai clinique de Phase 3 RESOLVE-IT sera verrouillée comme prévu, avant la fin du mois de février.

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