Inventiva Pharma

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Gillepils
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Re: Inventiva Pharma

Berichtdoor Gillepils » 23 Mei 2018 08:48

Blackbelt schreef:Eerste pakketjes is binnen aan 7,44, maar mijn order is niet volledig uitgevoerd.
Volumes zijn zeer laag voor dit aandeel...


Er is ook heel weinig 'free float' en daar is dan nog een deel van in handen van institutionals...



Brammeke
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Re: Inventiva Pharma

Berichtdoor Brammeke » 30 Mei 2018 00:15

bijgekocht aan 7,60.
gemiddeld aan 7,57.

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Re: Inventiva Pharma

Berichtdoor Brammeke » 12 Jun 2018 09:16

INVENTIVA to Present at the 2018 JMP Securities Life Sciences Conference


11 juni 2018 17:45

Inventiva to Present at the 2018 JMP Securities Life Sciences Conference
Daix (France), June 11, 2018 - Inventiva S.A. ("Inventiva" or the "Company"), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced that Frédéric Cren, Chief Executive Officer and co-founder of Inventiva, will participate in the panel discussion "NASH: Making Sense of the Pipeline" at the upcoming 2018 JMP Securities Life Sciences Conference being held on June 20-21, 2018 at The St. Regis New York hotel, New York, USA. The event details are as follows:
Date: Thursday, June 21, 2018
Time: 08:00 am (Eastern Time)
Panel: "NASH: Making Sense of the Pipeline"
Location: Louis XVI room, The St. Regis New York hotel
About Inventiva: http://www.inventivapharma.com
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva's research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.
Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.
Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morqio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.
Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.
Inventiva employs over 100 highly qualified employees and owns state-of-the-art R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.
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Re: Inventiva Pharma

Berichtdoor Blackbelt » 14 Jun 2018 22:20

Ingestapt aan 7,41 gemiddeld.

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Re: Inventiva Pharma

Berichtdoor Brammeke » 21 Jun 2018 10:04

Press Release: INVENTIVA : FDA Approval of an Investigator Initiated IND Application to Conduct Phase II Study of Lanifibranor in Type 2 Diabetic Patients with Non-Alcoholic Fatty Liver Disease

Press Release: INVENTIVA : FDA Approval of an Investigator Initiated IND Application to Conduct Phase II Study of Lanifibranor in Type 2 Diabetic Patients with Non-Alcoholic Fatty Liver Disease
FDA Approval of an Investigator Initiated IND Application to Conduct Phase II Study of Lanifibranor in Type 2 Diabetic Patients with Non-Alcoholic Fatty Liver Disease -- Study to enroll first patient in the third quarter 2018 with topline results expected early 2020 -- FDA approval is a positive signal for SSc and NASH IND applications Daix (France) June 20, 2018 - Inventiva S.A. ("Inventiva" or the "Company"), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced that the U.S. Food and Drug Administration (FDA) has accepted the investigator initiated Investigational New Drug (IND) application providing clearance to proceed with the Phase II study of lanifibranor in type 2 diabetic patients with nonalcoholic fatty liver disease (NAFLD). This FDA approval is also a positive signal for the planned Company IND applications in SSc and NASH. The trial to be conducted by Dr. Kenneth Cusi, Chief of the Division of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida, Gainesville, is expected to enroll 64 patients treated for a 24-week period with a single daily dose of lanifibranor (800 mg/day) or placebo and 10 subjects in a healthy, non-obese control group. The study´s overall objective is to measure the metabolic improvements induced by lanifibranor, and its effect on steatosis in type 2 diabetic patients with NAFLD. Additionally, this study will detect lanifibranor´s impact on fibrosis using the most recent imaging and biomarker technology. Its main endpoints are a decrease of liver steatosis assessed by state-of-the-art imaging, including H-MRS (Proton Magnetic Resonance Spectroscopy), a decrease of insulin resistance (glucose clamp, HBA1c), a decrease in de novo lipogenesis, and safety. The first patient is expected to be enrolled in the third quarter of 2018 and topline results are expected beginning of 2020. "With its unique pan-PPAR profile, lanifibranor has shown very good safety features, relevant efficacy data in NASH preclinical models as well as positive metabolic effects in a Phase IIa study in diabetic patients," Dr. Cusi said. "We anticipate the results of this study to translate well to diabetic patients with NAFLD or NASH and look forward to demonstrating that lanifibranor could become a very valuable drug for these patients." Jean-Louis Abitbol, MD, MSC, Chief Medical Officer of Inventiva, added: "We are delighted that the FDA has allowed Dr Cusi and his team to proceed with this exciting metabolic and imaging study and we very much look forward to the enrollement of US patients as these results will provide additional supporting data for our regulatory filings with US and European regulators."
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Re: Inventiva Pharma

Berichtdoor Stofke » 21 Jun 2018 22:39

De Amerikaanse Food & Drug Administration (FDA) heeft de IND-aanvraag (Investigational New Drug Application) goedgekeurd die nodig is om te starten met een door onderzoekers geïnitieerde Lanifibranor fase II-studie bij patiënten met diabetes type 2 die lijden aan niet-alcoholische leververvetting. In april liet Inventiva weten dat het hoofd van de afdeling Endocrinologie, Diabetes en Metabolisme aan de universiteit van Florida Lanifibranor had geselecteerd voor een fase II-studie. Die studie zal 64 patiënten rekruteren die gedurende 24 weken behandeld worden met ofwel een placebo, ofwel een enkele dosis Lanifibranor één maal per dag. De eerste inschrijvingen worden verwacht in het derde kwartaal van 2018, met toplijnresultaten begin 2020.
Dat Lanifibranor wordt gekozen voor een door onderzoekers geïnitieerde studie toont volgens analist Lenny Van Steenhuyse de interesse van de medische gemeenschap aan en benadrukt het brede potentieel van de molecule. Bovendien valideert de IND-goedkeuring van de FDA het veiligheidsprofiel van Lanifibranor, wat in het verleden voor dit type molecule niet altijd het geval was. Het is ook een goed voorteken voor toekomstige IND-aanvragen die het bedrijf wil indienen voor niet-alcoholische leverontsteking (NASH) en systemische sclerose. De resultaten van deze lopende fase II-studies worden resp. in de tweede helft van 2019 en begin 2019 verwacht. Kortom, een duidelijk positieve ontwikkeling voor Inventiva, nu een door een Amerikaanse onderzoeker geïnitieerd onderzoek kan starten met het inschrijven van patiënten. Dit wordt de derde lopende fase II-studie met Lanifibranor, naast NASH en systemische sclerose.

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Re: Inventiva Pharma

Berichtdoor Brammeke » 29 Jun 2018 09:46

Voorlopig? afscheid genomen IVA aan 7,22.
verlies 5%.
Port een beetje herschikken. Te veel verschillende aandelen. Wordt moeilijk alles op de voet te volgen.

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Re: Inventiva Pharma

Berichtdoor Gillepils » 16 Jul 2018 10:57

Iemand die de reden van de plotse stijging van vandaag weet?

Laatste nieuws was een week geleden al:

Inventiva Announces Positive DSMB Reviews in both NASH
and Systemic Sclerosis Phase IIb Trials with Lanifibranor
► Both DSMB recommend trials to continue without changing the protocol
► Lanifibranor safety is confirmed
► Trials to continue as planned
Daix (France) June 20, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company
developing innovative therapies in nonalcoholic steatohepatitis (“NASH”), systemic sclerosis (“SSc”) and
mucopolysaccharidosis (“MPS”), today announced that the FASST (For A Systemic Sclerosis Treatment) Data
Safety Monitoring Board (“DSMB”) held its third and last meeting before the end of the trial of lanifibranor in SSc.
Similarly to the conclusions of the first two DSMBs , the board recommended that the study continue without any
modification to the protocol. Similarly the NATIVE (NASH Trial to Validate IVA337 Efficacy) DSMB met for the first
time and after reviewing all safety data came to a similar conclusion and recommended to continue the study
without any modification of the protocol. The positive outcomes of these two DSMBs confirm the good safety of
lanifibranor, already demonstrated in long-term toxicological studies as well as in phase I and phase II clinical
trials. Both studies are progressing as planned with no specific concerns and topline results are anticipated in early
2019 for the FASST trial in SSc and second half of 2019 for the NATIVE trial in NASH.
About Lanifibranor:
Lanifibranor is a next generation panPPAR modulator designed as a moderately potent and well balanced PPAR
  and . This unique profile was conceived in order to obtain an optimal therapeutic margin with strong efficacy
and tolerance. Inventiva is currently evaluating lanifibranor in two parallel Phase IIb clinical studies in NASH and
SSc.
About the Phase IIb FASST trial:
The Phase IIb FASST trial is a one-year randomized double-blind study designed to measure the effect of
lanifibranor on the progression of systemic sclerosis (SSc). Patients will receive either lanifibranor or placebo
according to the study protocol, approved by the European Medicines Agency (EMA). The primary endpoint is
change in the Modified Rodnan Skin Score (MRSS), which is a measure of disease progression accepted by both
Food and Drug Administration (FDA) and the EMA. Inclusion criteria are based on a MRSS between 10 and 25, and
diffuse systemic sclerosis diagnosed from less than 3 years. Patients are allowed to continue their ongoing
treatments, including immunosuppressive therapies. Lanifibranor has been granted orphan drug status for the
treatment of systemic sclerosis by the EMA and the FDA. The orphan drug status provides certain advantages for
the sponsor such as reduced procedure costs and commercial exclusivity.
About the Phase IIb NATIVE trial:
PRESS RELEASE
2
The Phase IIb NATIVE trial is a 24-week randomized double-blind study designed to assess the efficacy of
lanifibranor on ballooning and inflammation without worsening of fibrosis. Patients will receive either lanifibranor
or placebo. This trial will also evaluate the safety of lanifibranor treatment. The main inclusion and assessment
criteria of the study are based on the hepatic histology of each patient: (i) NASH histological diagnosis according
to the NASH Clinical Research Network criteria (steatosis, lobular inflammation of any degree and liver cell
ballooning of any amount) and (ii) SAF activity score of 3 or 4 (> 2), SAF Steatosis score >= 1 and SAF Fibrosis score
< 4. The primary endpoint of the study is a decrease in relation to the baseline of >= 2 points of the SAF activity
score combining hepatocellular inflammatory and ballooning
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Re: Inventiva Pharma

Berichtdoor Biobelegger07 » 14 Aug 2018 12:22

Positieve resultaten voor Lanifibranor

Nijnijn
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Re: Inventiva Pharma

Berichtdoor Nijnijn » 21 Aug 2018 08:56

Bolero 14/08/2018

Biotechbedrijf Inventiva publiceerde initiële onderzoeksresultaten van twee studies die inzicht moeten bieden in het kankerverwekkende profiel en de veiligheid van hoofdproduct Lanifibranor. Dat moet fibrotische ziekten zoals NASH en systemische sclerose kunnen behandelen. De data lijken (alweer) te bevestigen dat het product zich positief onderscheidt van andere PPAR-agonisten en dat moet de weg vrijmaken voor het opstarten van een fase III studie. Het is nu wachten op fase IIb data van Lanifibranor voor systemische sclerose (begin 2019), terwijl de fase IIb NASH gegevens in de tweede helft van 2019 worden verwacht. KBC Securities blijft bij zijn koopadvies en koersdoel van 9,5 euro.