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Genfit 2019

117 Posts, Pagina: « 1 2 3 4 5 6 » | Laatste
sp1946
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GENFIT announces FDA Grant of Breakthrough Therapy Designation to Elafibranor for the Treatment of PBC

Lille (France), Cambridge (Massachusetts, United States), April 18, 2019 – GENFIT (Nasdaq and Euronext: GNFT - ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that its lead product candidate elafibranor was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid (UDCA)...

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quote:

sp1946 schreef op 18 april 2019 08:54:

GENFIT announces FDA Grant of Breakthrough Therapy Designation to Elafibranor for the Treatment of PBC

Lille (France), Cambridge (Massachusetts, United States), April 18, 2019 – GENFIT (Nasdaq and Euronext: GNFT - ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that its lead product candidate elafibranor was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid (UDCA)...


www.globenewswire.com/news-release/20...
sp1946
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Barclays likes Genfit in premarket analyst action

Apr. 22, 2019 8:58 AM ET|About: Canopy Growth Corporation (CGC)|By: Douglas W. House, SA News Editor
Genfit (NASDAQ:GNFT) initiated with Overweight rating and $55 (120% upside) price target at Barclays.
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To date, Genfit’s elafibranor is the only advanced therapy to successfully treat NASH without increased scarring of the liver, or fibrosis, which can lead to cirrhosis.  Additionally, patients’ lipid and metabolic profiles improved, and earlier trials continuously showed the therapy was safe and tolerable.

www.forbes.com/sites/genemarcial/2019...
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Genfit: GENFIT Launches a Phase 2 Trial Evaluating Elafibranor on Hepatic Lipid Composition for NAFL

Elafibranor, a PPAR alpha/delta agonist, is currently the only late-stage, Phase 3 (RESOLVE-IT) therapy undergoing investigation for “NASH resolution without the worsening of fibrosis” (approved regulatory endpoint for Phase 3 trials), and could be the first therapy able to eliminate the underlying cause of NASH disease progression. The results from the P2b GOLDEN trial showed elafibranor’s unique ability to address NASH resolution, and beneficial effects on cardiometabolic lipids (LDL decrease, HDL increase, and TG decrease), glucose metabolism (HbA1c, HOMA-IR, FPG, FFA, C-peptide), in addition to a favorable safety and tolerability profile. Therefore, elafibranor’s superior, pluripotent mechanism of a PPAR alpha and delta, could be beneficial by improving quantity and quality of fat in the liver, specifically targeting the more harmful, lipotoxic fat subtypes that buildup in NAFLD and drive progression to NASH

www.globenewswire.com/news-release/20...
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DeZwarteRidder
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Dr. Bob schreef op 11 juni 2019 13:52:

Felle marktreactie op het nieuws van Cymabay (-40% pre-market!).

Sleept Genfit mee naar beneden :(

seekingalpha.com/news/3470340-cymabay...
Dit gaat volledig volgens verwachting.......

De ENIGE met een nash-kans is Viking.
sp1946
1
June 11, 2019 GENFIT: Cymabay Phase 2 data: read-across for RESOLVE-IT?

Dear investor,

In reaction to the confusion generated by Cymabay's Phase 2b announcement earlier today, we'd like to bring to your attention a few important points:

- Reduction of liver fat content measured by MRI-PDFF or any other means is not considered by regulators as relevant for approval in NASH

- Approval is based on "NASH resolution without worsening of fibrosis" solely defined with "hepatocyte ballooning” and “lobular inflammation”, through histological examination irrespective of steatosis evolution

- According to this definition, in a 52w Phase 2b trial, elafibranor achieved “NASH Resolution without worsening of fibrosis”, and its on-going Phase 3 trial RESOLVE-IT will readout by year-end, after 72w, on the same regulatory endpoint

- Elafibranor (dual PPARa/d agonist) activates complementary pathways via alpha and delta (eg. inflammation), and it has shown positive activity on HbA1c, HDL, insulin sensitivity

As a reminder, we believe elafibranor is uniquely positioned in NASH with the potential to become the first monotherapy to be approved by the FDA and the EMA for “NASH resolution without worsening of fibrosis” (ballooning = 0; inflammation = 0 or 1). Phase 2b data published in Gastroenterology, by Ratziu, in May 2016, have shown elafibranor’s unique potential to combine:

- efficacy on the regulatory endpoint, approved for Phase 3 trials, that is related to the underlying cause of disease progression to cirrhosis or cancer;

- improvement of the cardiometabolic risk profile (reduction of LDL and TG, increase of HDL, and improvement of insulin sensitivity);

- favorable safety and tolerability profile.

If the molecule’s beneficial activity is confirmed in Phase 3 – the duration of which is 6 months longer than the Phase 2 – elafibranor would be ideally positioned to be prescribed as first line treatment in monotherapy against NASH and as backbone of future combination therapy.

It is also important to realize that while fat is playing a role during the onset of NASH, evolution of fat composition is more important than just fat quantity. In line with this, GENFIT has recently launched a Phase 2 trial to evaluate elafibranor’s impact on hepatic lipid composition for NAFL.


GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 2
INFORMATION NOTE


This communication contains certain forward-looking statements, including those within the meaning of the Private Securitie
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GENFIT and Terns Pharmaceuticals Announce $228MM Strategic Partnership to Develop and Commercialize Elafibranor in Greater China

www.globenewswire.com/news-release/20...
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Onderstaand de link naar een wetenschappelijk rapport dat op 21 juni 2019 is gepubliceerd met de resultaten van een onderzoek naar de combinatie van OCA en Elafibranor.

www.nature.com/articles/s41598-019-45...

DeZwarteRidder
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DeZwarteRidder schreef op 5 maart 2019 19:14:

Intercept zal nog veel verder in elkaar storten.
Koers Intercept is nu gedaald van ca 108 naar 63.
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GENFIT: FDA and EMA Grant GENFIT’s Elafibranor Orphan Drug Designation for Primary Biliary Cholangitis (PBC)

www.globenewswire.com/news-release/20...
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GENFIT´s Quest to Bring the First NASH Therapy to Market

Hum is not worried by Cymabay’s results and believes that the dual action of elafibranor is key to its success. He says evidence suggests that activation of both PPAR alpha and delta, as opposed to PPAR delta alone, can decrease the amount of toxic fats in the liver.

“People have to realize that elafibranor activates PPAR alpha, as well as PPAR delta. It hits on both of those targets. Seladelpar works only on PPAR delta,” explained Hum.

labiotech.eu/interviews/dean-hum-genf...
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DeZwarteRidder
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Meanwhile, Genfit is also facing its own doubters. In mid-June, rival biotech company CymaBay Therapeutics (CBAY) offered a disappointing look at its PPAR drug in a Phase 2b study. In that study, reductions in liver fat remained minimal and insignificant compared with a placebo.
"These data raise the risk for Genfit whose drug, elafibranor, is also a PPAR and we believe already had a low likelihood of success on NASH resolution in its upcoming year-end 2019 Phase 3 readout," RBC Capital Markets analyst Brian Abrahams said in a June report.
Lingus
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Niet veel hoopgevende kandidaatmedicijnen meer voor NASH. NASH is een slagveld geworden. Grote verschillen tussen 52wk high de huidige koersen. Conatus -96%, Galectin -35%, Madrigal -56%, Viking -55%, Can-Fite -91%, Intercept -43%, Genfit -43%, Galmed -61% enzovoorts. Momentopname, appels en peren, ik weet het, maar het geeft aan dat de NASH hype voorbij is en koersen op weg zijn naar realistische waarden. Viking heeft mooie onderzoeksresultaten, een goede cashpositie en als enige over in mijn porto. Galmed en Genfit het afgelopen jaar met verlies eruit geknikkerd. Komende dinsdag een conference call op de Q3 resultaten van Viking. Ik ben natuurlijk vooral nieuwsgierig naar de vooruitzichten.
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GENFIT Announces Results of NIS4, an Investigational Non-Invasive NASH Diagnostic, at AASLD 2019

NIS4 is GENFIT’s innovative non-invasive in vitro diagnostic test, or IVD, to identify patients with NASH who may be appropriate candidates for drug therapy
Program is based on the in-house discovery of a 4-biomarker algorithm potentially replacing biopsy with a single blood test
Study finds patients living with type 2 diabetes are at increased risk of being diagnosed with NASH

Lille (France), Cambridge (Massachusetts, United States), November 10, 2019 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced results from a study demonstrating NIS4, an innovative non-invasive diagnostic blood test designed to diagnose nonalcoholic steatohepatitis (NASH), outperformed other non-invasive diagnostics in identifying NASH in people with type 2 diabetes. These data will be presented at AASLD The Liver Meeting® 2019 in Boston today, November 10 from 12:30PM-1:30PM (Poster #1757).

The study titled, “Type 2 diabetes as a risk factor for NASH and fibrosis in a cohort of 2363 patients with suspicion of NAFLD: use of NIS4 for identification of at-risk NASH in diabetic patients” explores how type 2 diabetes is a risk-factor for NASH and liver fibrosis, and also compares the diagnostic performance of NIS4 vs other non-invasive blood marker-based scores in a population of patients with type 2 diabetes. Cohort 1 (N=820) assessed the influence of type 2 diabetes status and anti-diabetic treatment on the prevalence of NAS>4 and F>2, while cohort 2 (N=275) assessed the diagnostic performance of NIS4 in patients with type 2 diabetes.

The data show that of the patients in Cohort 1, the presence of type 2 diabetes is associated with increased prevalence of active NASH (NAS­>4) and significant fibrosis (F>2), i.e. at risk of progression to serious liver outcomes. The probability of having NAS>4 with F>2 increases with the number of additional anti-diabetic therapies taken by patients to control their glycemia, irrespective of the antidiabetic drug classes used, whether insulin or non-insulin drugs. The data accentuate the need for active surveillance of liver injury in patients with type 2 diabetes, in order to identify those at need of intervention to prevent evolution to clinically relevant hepatic outcomes.

The data from cohort 2 also show that NIS4 significantly outperformed existing non-invasive diagnostic tests in accurately identifying NASH (NAS>4) and significant fibrosis (F>2) in patients with type 2 diabetes. Specifically, NIS4 had an area under receiver operating characteristic (AUROC) performance of 0.801 [0.748; 0.854] (p<0.01) that is statistically superior compared to FIB41 (0.704 [0.641; 0.767]), NFS2 (0.597; [0.527; 0.667]), ELF3 (0.704. [0.642; 0.766]) and Fibrometer (0.678, [0.613; 0.743]). Therefore, NIS4 can demonstrate good diagnostic performance and accurately identify NASH (NAS>4) and significant fibrosis (F>2) in patients with type 2 diabetes.

“These results reiterate the potential superiority of NIS4, our in-house developed four biomarker panel, to statistically identify NASH and fibrosis with superior sensitivity and specificity also observed in patients with type 2 diabetes,” said Suneil Hosmane, Ph.D., Head of Global Diagnostics at GENFIT. “Our ongoing research in this area underscores our commitment to improving diagnosis and treatment experiences for patients with NASH, a potentially life-threatening disease that is on the rise, yet significantly underdiagnosed.”

“The findings presented today are great news for researchers, clinicians and people who are at-risk for NASH. This simple blood test will be instrumental in the NASH patient journey and provide physicians with the tool to identify patients in need of therapeutic intervention,” said Stephen Harrison, study author and Medical Director of Pinnacle Clinical Research. “While liver biopsy is the current clinical reference standard for diagnosis, it is a costly, invasive procedure that can cause pain and discomfort for patients, and can even have serious, life-threatening complications. Currently there are no minimally-invasive tests approved specifically for NASH, which is expected to soon be the primary cause of liver transplant.”

ABOUT NIS4

GENFIT is developing an in vitro diagnostic (IVD) test to identify patients with NASH and fibrosis (F>2, NAS>4), who are the focus of current NASH clinical trials. The NIS4 program is based on the in-house discovery of a 4-biomarker algorithm and is currently pursuing commercialization of this test which aims to be a validated alternative to the liver biopsy. In January, 2019, GENFIT signed a licensing agreement with LabCorp® to roll out the diagnostic kit in the clinical research field, and plans to file NIS4 for formal marketing approval with the FDA in 2020.
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Vertraagd 19 jul 2024 13:27
Koers 4,035
Verschil -0,160 (-3,81%)
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