GENFIT - ALGFT - FR0004163111

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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

Another swing, another miss' for Gilead as NASH combo flops in phase 2
by Amirah Al Idrus | Dec 16, 2019 11:01am

https://www.fiercebiotech.com/biotech/a ... ps-phase-2



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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

As Nash shifts again, the focus remains on Genfit’s big readout


Genfit investors, who early next year will see the Resolve-It study yield data, digest further developments in the Nash space.


The once red-hot therapy area of Nash is mired in clinical setbacks, and this week it added two more disappointments: today Boehringer Ingelheim canned one of its many deals in this space, two days after Gilead revealed that its multi-project Atlas study had failed.

True, the Gilead setback was not a great surprise, and there was a separate positive development as Poxel today claimed an early clinical Nash win. But the riskiest bet of all remains Genfit, whose future hangs in the balance as its crucial pivotal study of elafibranor is due to yield results early next year.

Though some of Genfit’s most bullish retail followers remain convinced of success in the Resolve-It trial, the industry’s numerous Nash failures have contributed to the French group’s stock declining 30% year to date (Cymabay is out, but for Genfit the band plays on, November 26, 2019).

Fear of interactions

The latest of these is Boehringer’s AOC3 inhibitor BI 1467335, which the German group today discontinued in Nash owing to the risk of drug-drug interactions.

This decision was taken in spite of an ostensibly positive phase IIa trial, and was based on “assessment of another recently completed phase I study”, Boehringer said. The group had licensed BI 1467335 from Pharmaxis for $30m up front in 2015, as part of a push into Nash that also saw it sign alliances with Yuhan, Dicerna and Mina.

It is unlikely that Boehringer’s enthusiasm for the space burns as brightly as it did a few years ago. The same can be said about Gilead, another company that had tried to buy its way into Nash, but which at its latest quarterly update barely mentioned this therapy area at all.

It seems that Gilead’s new chief executive, Daniel O’Day, does not share the commitment to Nash of his predecessor, especially given this year’s failure of Gilead’s Ask1 inhibitor selonsertib.

If this was a sign that the Atlas study was likely to fail then such fears were confirmed on Monday; Gilead said none of the three combinations tested in Atlas hit the primary endpoint, proportion of patients achieving ≥1-stage improvement in fibrosis without worsening of Nash.

The trial was exploring combinations of selonsertib, the ACC inhibitor firsocostat and cilofexor, an FXR agonist. Echoing earlier findings the most promising readings emerged from the arm testing firsocostat plus cilofexor; patients in this cohort demonstrated significant improvements in various fibrosis measures and liver function.

Whether Gilead considers these signals strong enough to justify further work is unclear, and safety is something to consider. The regimen caused as 28.2% rate of mild to moderate pruritus while 3.9% of patients experienced a big jump in triglyceride levels.

This is a known issue with ACC inhibitors – Pfizer’s candidate in this class, PF-05221304, caused 10% of patients to experience hypertriglyceridemia, it was revealed at AASLD, taking the shine off a dramatic impact on liver fat.

Developers are adding fenofibrates to these combinations to ameliorate this off-target effect, and this is probably where Gilead’s focus now turns. Last month the company added a Vascepa plus firsocostat plus cilofexor arm to a separate phase II study, another cohort of which includes fenofibrate with the same combination; results are due later in 2020.

Early win?

Against such a backdrop any positive developments are welcome, and one was provided today when the French group Poxel said PXL065 showed an acceptable pharmacokinetic profile in phase I. This led it to decide that a 36-week phase II study in biopsy-proven Nash should start next year.

However, PXL065 is merely a deuterium-stabilised stereoisomer of Takeda’s ill-fated diabetes treatment, Actos. The toxicity of such PPAR agonist glitazone drugs has led to contraindications, and for now all Poxel can do is point to a dog study backing PXL065’s improved safety over Actos.

The detail will be of interest to Genfit, whose elafibranor is also a PPAR – though targeting the alpha and delta subunits eliminates the risk of serious toxicity, the group’s fans argue. Either way, the debate should be settled with the imminent readout of Resolve-It.

Just last week yet another contender, Intercept, revealed that its Nash project Ocaliva would likely face a US advisory panel on April 22, delaying a regulatory decision beyond the March 26 PDUFA date that priority review had brought it.

Ocaliva is widely expected to receive a grilling, so even if the chances of a Nash drug seeing the light of day are diminishing the space can hardly be called dull.




https://www.evaluate.com/vantage/articl ... ig-readout

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Re: GENFIT - ALGFT - FR0004163111

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Will we see the world's first approved NASH drug in 2020?

Nonalcoholic steatohepatitis (NASH) has been among the closely watched indications in biotech since January 2014, when Intercept Pharmaceuticals lit a fire under the field with midphase data that sent its share price up 500%. Now, Intercept is on the cusp of delivering on the promise that caused investors to pile into the stock.

On April 22, an advisory committee is set to assess the merits of the data on obeticholic acid (OCA), teeing the FDA up to decide whether to make Intercept’s drug the first treatment approved in NASH. Genfit’s elafibranor is following close behind, with phase 3 results scheduled for the first quarter of 2020. If the FDA authorizes either drug, it will mark the start of a new phase in the intense scrap for the blockbuster NASH market.

However, it may take time for the NASH market to live up to the blockbuster forecasts. Neither OCA nor elafibranor has entirely convinced in clinical trials, with Intercept’s drug dogged by a troublesome side effect profile and Genfit’s rival failing a phase 2 study. The data could deter physicians and payers from backing the first NASH drugs, potentially limiting use to the sickest NASH patients.

Today, a liver biopsy is needed to make a definitive diagnosis. It is unclear whether payers, physicians and patients will see the costly, invasive procedure as a price worth paying to get the moderate efficacy shown by the leading NASH drugs. In the longer term, noninvasive tests and new NASH drugs and combinations may tip the balance in favor of greater use of pharmacological interventions.

Yet, despite the headwinds, Intercept will need to hit the ground running to live up to expectations. Analysts have tipped OCA to deliver blockbuster sales, with some forecasts made during its clinical development running as high as $8 billion.

https://www.fiercebiotech.com/biotech/w ... -drug-2020

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Re: GENFIT - ALGFT - FR0004163111

Bericht door And its gone! »

Genfit terug in goede doen.
GOOGL, BAYN, DBK, CYAD, TNG, ALPHA, IPH, RDSA, IVA, VYGR, HARP, YMAB, BCYC, ZYME, GERN, BNTX, SWTX, BPMC, TRIL.

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Re: GENFIT - ALGFT - FR0004163111

Bericht door And its gone! »

Alles verkocht aan 18,5€.
6% winst, belachelijk natuurlijk gezien het potentieel maar goed, ik hou het verder vanop afstand in de gaten.
Ik heb niet het gevoel dat er veel enthousiasme ontstaat, geen FOMO, niet in Europa en niet in de US.
Het uitstellen van de resultaten, het vertrek van CEO, de eindeloze stroom mislukkingen van de concurrenten, erg veel vertrouwen heb ik er niet in.
Bovendien een grotere positie in Inventiva, die op dezelfde indicatie mikt.
GOOGL, BAYN, DBK, CYAD, TNG, ALPHA, IPH, RDSA, IVA, VYGR, HARP, YMAB, BCYC, ZYME, GERN, BNTX, SWTX, BPMC, TRIL.

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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

And its gone! schreef:
10 jan 2020 17:41
Alles verkocht aan 18,5€.
6% winst, belachelijk natuurlijk gezien het potentieel maar goed, ik hou het verder vanop afstand in de gaten.
Ik heb niet het gevoel dat er veel enthousiasme ontstaat, geen FOMO, niet in Europa en niet in de US.
Het uitstellen van de resultaten, het vertrek van CEO, de eindeloze stroom mislukkingen van de concurrenten, erg veel vertrouwen heb ik er niet in.
Bovendien een grotere positie in Inventiva, die op dezelfde indicatie mikt.


Ik zit ook sterk te twijfelen om te verkopen....
Ik deel uw mening mbt de recente mislukkingen concurrenten, CEO vertrek, ....

Maar ik heb nu 40 % winst....dus ik kan me al iets permitteren ... dus ik blijf nog even zitten...
En als er toch goede resultaten zouden komen .... dan is de kans heeeel groot op partnership of overname....

En bij slechte resultaten.... onmiddellijk Viking Therapeutics en ook Madrigal bijkopen!!
And its gone! liked last!

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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »


Madrigal: Beyond NASH
Jan. 14, 2020 12:35 PMMadrigal Pharmaceuticals, Inc. (MDGL)AMRN, GILD, GLMD

Summary
After the robust Phase 2 NASH data for resmetirom, Madrigal commenced its Phase 3 trial earlier this year.
There is another upcoming Phase 3 investigation to study resmetirom's potential use for heart disease related to NASH. That's in similar territory for Amarin's Vascepa.
Riding ample cash and a potential mega-blockbuster, Madrigal is worth much higher than its current stock price.


Zie onderstaande link voor het volledige artikel :

https://seekingalpha.com/article/431676 ... eyond-nash

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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

Technische analyse

GENFIT : RÉVEIL CONJOINT DES COURS ET DES VOLUMES

Aujourd'hui à 09:00
(BFM Bourse) - Sur la base d’une argumentation graphique, les analystes de BFM Bourse ont sélectionné GENFIT pour les investisseurs actifs.

ELEMENTS GRAPHIQUES CLES
L'analyse graphique en données quotidiennes de l'action GENFIT permet d'identifier une tendance haussière à court terme, depuis la reconquête de la moyenne mobile à 100 jours (en orange), courbe de tendance de fond de l'action, qui s'infléchit d'ailleurs nettement. Sur le plan des indicateurs de tendance, la moyenne mobile à 20 jours (en bleu foncé) fait depuis office de support pour les cours. Après une fédération massive des acheteurs (19 - 27 décembre), le titre s'est engagé dans une phase de respiration en mince canal (17,50 - 19 euros) dont une sortie par le haut de façon précoce est envisagée.

PREVISION
Au regard des facteurs graphiques clés que nous avons mentionnés, notre avis est haussier sur l'action GENFIT à court terme.

Les investisseurs actifs prendront position à l'achat sur le titre GENFIT au cours de 18.680 € avec un objectif à 24.900 € en ligne de mire. Ils protégeront leur capital en plaçant un stop à 16.990 €.



https://www.tradingsat.com/genfit-FR000 ... 95337.html

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Re: GENFIT - ALGFT - FR0004163111

Bericht door Soppi »

Interessant artikel ivm Intercept Pharmaceuticals...
En hun product OCA wat hopelijk in April 2020 zal goedgekeurd worden door FDA in een speciale advisory panel

On the cusp of FDA approval for its NASH drug, Intercept’s CEO talks payers, pruritis, and price

https://www.statnews.com/2020/01/14/on- ... tis-price/

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Re: GENFIT - ALGFT - FR0004163111

Bericht door kenzo »

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

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