Poxel to Report Its 2023 Annual Results by the End of April 2024
LYON, France--(BUSINESS WIRE)--POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to PXL770 for the treatment of patients with autosomal-dominant polycystic kidney disease (ADPKD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator – and is also a Phase 2 ready ADPKD asset, subject to additional financing.
LYON, France--(BUSINESS WIRE)--POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2022 and provided a corporate update.
IMEGLIMIN with Novell Process IMEGLIMIN
POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders, today announced with its partner, Sumitomo Dainippon Pharma, that the product launch of TWYMEEG®1 (Imeglimin hydrochloride), 500mg tablets for the treatment of type 2 diabetes in Japan, is planned for September 16, 2021. TWYMEEG is Poxel’s first product to reach commercialization and Japan is the first country where the product has been approved. Poxel has received a milestone payment of JPY1.75 billion (EUR13.2 million, USD15.8 million)2 from Sumitomo in July for the approval of TWYMEEG. Additionally, as part of the license agreement with Sumitomo, Poxel is entitled to receive escalating double-digit royalties on net sales (based on Poxel’s current forecast) and sales-based payments of up to JPY26.5 billion
Just a few years after Vivek Ramaswamy’s epic Alzheimer’s fail, another one of his startups is cutting its losses because of a high-risk endeavor — this time on the diabetes front — didn’t pan out.
Poxel has shared the phase 3 data it hopes will secure approval for Type 2 diabetes drug imeglimin in Japan. The readouts link the oral oxidative phosphorylation blocker imeglimin to near- and long-term improvements when given as a monotherapy and in combination with other drugs.
LYON, France--(BUSINESS WIRE)--POXEL SA (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), today announced that it presented Imeglimin Phase 3 results for TIMES 2 and TIMES 3 and new preclinical results for PXL770 in a cardio-renal disease model at the 56th European Association for the Study of Diabetes (EASD) Annual Meeting, which is being held virtually. The poster presentations can be accessed on Poxel’s website using the following link: https://www.poxelpharma.com/en_us/product-pipeline/posters.
Strengthened financial position during H1 2020 with drawdown of IPF loan of EUR 10 million and a capital raise of EUR 17.7 million
POXEL SA (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), and Sumitomo Dainippon Pharma Co., Ltd (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE), today announced positive topline results from TIMES 2, a Phase 3 trial evaluating Imeglimin in combination with approved hypoglycemic therapies, and as a monotherapy, for the treatment of type 2 diabetes in Japan. These results mark the successful conclusion of the Phase 3 program in Japan, referred to as TIMES (Trials of IMeglimin for Efficacy and Safety), which included three pivotal trials to evaluate Imeglimin’s efficacy and safety in over 1,100 patients.