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sp1946
1
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)...

Brouya
0
quote:

sp1946 schreef op 18 apr 2019 om 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
0
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.
Brouya
1
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...
Brouya
0
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...
Dr. Bob
0
DeZwarteRidder
0
quote:

Dr. Bob schreef op 11 jun 2019 om 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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