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Poxel

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  1. sp1946 19 oktober 2019 11:22
    Maandagmiddag 16.00 uur.

    • Presentation will include an overview of Poxel’s two clinical-stage programs for the treatment of NASH
    LYON, France--(BUSINESS WIRE)-- POXEL S.A. (Euronext – POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), announced today that it will be featured as a presenting company at the H.C. Wainwright 3rd Annual NASH Investor Conference and the Company will provide an overview of its two clinical stage candidates, PXL770, a direct adenosine monophosphate-activated protein kinase (AMPK) activator and PXL065, a mitochondrial pyruvate carrier (MPC) inhibitor, being developed for the treatment of NASH. Clinical results for PXL770 and PXL065 are expected in the fourth quarter of 2019.
    The H.C. Wainwright 3rd Annual NASH Investor Conference is being held on October 21, 2019 at The St. Regis Hotel in New York City. The Company will present an overview of its NASH programs on Monday, October 21st from 4:00-4:20 PM ET.
    The presentation at the H.C. Wainwright 3rd Annual NASH Investor Conference will be webcast live. To access the webcast, please visit the following link wsw.com/webcast/hcw6/poxel.pa/. The webcast replay will remain available for 90 days following the live presentation.
    For PXL770, two clinical trials are currently underway. One trial is a Phase 2a clinical study examining the efficacy and safety of PXL770 with results expected in the second quarter of 2020. In parallel, a pharmacokinetic (PK) and pharmacodynamic (PD) trial is ongoing to assess the full PK profile and PD effect on target pathways and metabolic parameters. Results from this trial are expected in the fourth quarter of 2019.
    For PXL065, a Phase 1b multiple ascending dose (MAD) trial is underway and results are expected in the fourth quarter of 2019. The Phase 1b MAD trial is designed to evaluate safety, tolerability and PK and support dose selection for the registration program.

  2. sp1946 8 november 2019 08:51
    Poxel Announces Positive Update Following FDA Meeting for PXL065 for Treatment of NASH

    November 08, 2019
    • FDA feedback supports plan to advance PXL065 using the 505(b)(2) regulatory pathway for NASH
    • 505(b)(2) process offers opportunity for a streamlined and efficient development plan
    • Poxel provides update on PXL065 Phase 2 trial designed to identify optimal dose or doses for Phase 3 registration trial; initiation expected 2Q 2020
    • LYON, France--(BUSINESS WIRE)-- POXEL S.A. (Euronext – POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), announced today an update for PXL065 following a positive meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter 2019. Based on feedback from the FDA, Poxel plans to advance PXL065 using a 505(b)(2) regulatory pathway, which will in part reference and rely on the Actos® (pioglitazone) product label and relevant published literature. NASH is a serious disease and PXL065 has the potential to address an unmet medical need, so the Company intends to seek Fast Track Designation. PXL065, the deuterium-stabilized R-stereoisomer of pioglitazone, is a mitochondrial pyruvate carrier (MPC) inhibitor being developed for the treatment of NASH.
    • “To my knowledge, PXL065 is in the unique position of being the first NASH clinical candidate being developed using a 505(b)(2) regulatory pathway with the potential to bridge to the vast amount of safety and efficacy data from pioglitazone studies,” said Stephen A. Harrison, MD, Visiting Professor of Hepatology, Radcliffe Department of Medicine, University of Oxford, UK. “Based on preclinical and clinical results, I am excited about the potential for an improved therapeutic profile for PXL065 compared to pioglitazone.”
    • A 505(b)(2) NDA contains full safety and effectiveness reports but has some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, from studies not conducted by or for the NDA applicant. Utilizing this regulatory pathway has the potential to result in a less expensive and faster route to approval compared with a traditional development path.
    • “We are very pleased with the FDA feedback for the PXL065 development program. Using the 505(b)(2) regulatory process should enable reliance on relevant Actos® data, including the product label and published literature, which is anticipated to be used as part of the data package for a future new drug application (NDA) for PXL065, pending successful completion of the Phase 2 and Phase 3 trials. The 505(b)(2) process in this context should provide the opportunity for an efficient and streamlined development plan with reduced financial and development risk,” said Thomas Kuhn, CEO of Poxel. “We plan to initiate a Phase 2 trial for PXL065 for the treatment of NASH during the second quarter of 2020 in biopsy-proven NASH patients. The primary objective of this trial is to determine the optimal dose or doses to be tested in a Phase 3 registration trial.”

  3. Pokerface 11 november 2019 16:02
    Even wat kritische vragen:
    1) Imeglimin richt zich op Diabetis Type 2. Wat maakt dat dit medicijn beter is dan de bestaande medicatie en dus een plaats in de markt verdient?
    2) Wat is de huidige cashpositie en wat is de cashburn per jaar? Met andere woorden: hoe lang kan Poxel het nog uitzingen voordat een emissie plaatsvindt?
    3) Wat zijn de koerstriggers voor de komende 12 maanden?
  4. sp1946 16 november 2019 12:09
    • Financing of up to EUR 30 million through a bond loan with IPF Partners
    • Draw down of the first tranche of EUR 6.5 million expected in November 2019
    • Cash balance at year-end 2019 expected to be above EUR 35 million
    “This EUR 30 million financing with IPF Partners strengthens our financial position and extends our cash runway into 2022, a date that potentially brings us through partner-related milestones as well as royalty income from Imeglimin sales in Japan
  5. sp1946 16 november 2019 12:13
    Imeglimin
    Imeglimin is the first orally-available anti-diabetes drug candidate that simultaneously targets all three key organs of diabetes, which includes the pancreas, liver, and muscles.
    Japan/Asia
    The steady growing, ~$4B* Japanese diabetes market offers a unique value creation opportunity. In Japan, China and 11 other Asian countries, Sumitomo Dainippon Pharma is our strategic partner for Imeglimin. For Japan, Poxel and Sumitomo Dainippon Pharma are jointly conducting the Phase 3 TIMES program for Imeglimin, which is being funded by Sumitomo Dainippon Pharma, and they will commercialize the product for this market. In China, South Korea, Taiwan and nine other Southeast Asian countries including Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, Myanmar, Cambodia, and Laos, Sumitomo Dainippon Pharma will be solely responsible for the development and commercialization of Imeglimin.
  6. [verwijderd] 3 januari 2020 13:38
    Net zoals bij Abivax zien we ook hier vandaag een dag van winstnemingen na de enorme stijging van afgelopen tijd.
    Poxel behoort tot mijn vaste pakket aandelen die ik zeker niet weg doe.
    De stijging boven de 10 euro is hier ook nog maar het begin geweest.
    Poxel is hot. Voor meer info gebruik ik veel de franse site boursorama.
    Succes, poil

  7. jeroengp01 7 januari 2020 13:32
    Interessant aandeel, ik ga het ook eens volgen. De potentiële markt is substantieel, dus als hun medicijnen succesvol op de markt komen, en concurrerend zijn, kan het een mooie groeiparel zijn. Laatste paar maanden wel al flink gestegen, pas achteraf weet je of dit slechts het begin was, of voorlopig even het(koers)plafond... Succes voor de al bestaande aandeelhouders!
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