お知らせ • Apr 30
Poxel S.A. to Report Fiscal Year 2025 Results on Jun 15, 2026 Poxel S.A. announced that they will report fiscal year 2025 results at 5:40 PM, Central European Standard Time on Jun 15, 2026 お知らせ • Nov 27
Poxel S.A., Annual General Meeting, Dec 11, 2025 Poxel S.A., Annual General Meeting, Dec 11, 2025. Location: 12 cours de verdun rambaud esplanade de la gare, lyon France お知らせ • May 28
Poxel SA Announces New Clinical and Scientific Data on TWYMEEG® to Be Presented at the 68th Annual Meeting of the Japan Diabetes Society POXEL SA announced that new clinical and scientific data on TWYMEEG will be presented at the 68th Annual Meeting of the Japan Diabetes Society (JDS 2025), taking place from May 29 to 31, 2025, in Okayama, Japan. A total of 15 presentations, including results from 7 clinical trials, 3 post-hoc analyses and 5 non-clinical studies supported by Sumitomo Pharma, will be delivered by leading Japanese diabetes experts. These findings further confirm TWYMEEG's efficacy in monotherapy and combination therapies, safety, dual mechanism of action and potential benefits in specific patient populations. Main topics include: TWINKLE (TWYMEEG®? in diabetic patients with renal impairment: A post-marketing long-term study) study (Phase 4 study): confirmation of TWYMEEG®? efficacy and safety in diabetic patients with renal impairment; FAMILIAR Study: confirmation of TWYMEE G®? efficacy and safety in combination with DPP-4 inhibitors; PARADIME Clamp: confirmation of TWYMeeG®? dual mechanism of action in diabetic patients - clinical data showing effects on insulin sensitivity (clamp part) and glucose stimulated insulin secretion (OGTT part); PARADIME TIR: confirmation of TWYMCEG®? effects on glucose variability; PET/MRI Study: confirmation of TWY MEEG®? effect on glucose excretion in the gut. お知らせ • Apr 08
Poxel SA Announces Regulatory Approval by Japanese Authorities to Expand TWYMEEG®? Package Insert to Include Type 2 Diabetes Patients with Renal Impairment POXEL SA announced that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved the revision of TWYMEEG®? package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m2. This approval follows positive topline results from the post-marketing clinical study TWINKLE (TWYMEEG®? in diabetic patients with renal impairment: A post-marketing long-term study) in Japanese type 2 diabetic patients with renal impairment, which confirmed TWYMEEG®®?'s safety and tolerability profile, as announced last August1. Based on these results, discussions with the Japanese regulatory authorities were initiated by Sumitomo Pharma, resulting in the approval that will be officially implemented by Sumitomo Pharma as of April 8, 2025. お知らせ • Nov 08
Poxel S.A. Provides Revenue Guidance for the Full Year 2024 Poxel S.A. provided revenue guidance for the full year 2024. The company to see the good sales trajectory for TWYMEEG in Japan, which should lead to the achievement of JPY 5 billion net sales in the coming months, at which point, Poxel will be entitled to 10% royalties on all TWYMEEG net sales and a sales-based payment of JPY 500 million (EUR 3.1 million).These amounts, based on recent royalty monetization agreement, will serve to start repayment of bonds to OrbiMed. Additionally, Poxel will benefit from the residual amount of the reserve deposit made under the terms of the agreement with OrbiMed, in addition to the USD 42.5 million proceeds received upon closing. お知らせ • Oct 24
Poxel S.A., Annual General Meeting, Nov 28, 2024 Poxel S.A., Annual General Meeting, Nov 28, 2024. Location: hotel mercure lyon, centre chateau perrache, 12 cours de verdun rambaud esplanade de la gare, lyon France お知らせ • Aug 07
Sumitomo Pharma and Poxel Announce Topline Results from Post-Marketing Clinical Study on TWYMEEG for the Treatment of Type 2 Diabetes in Japan Sumitomo Pharma Co., Ltd. and POXEL SA announced topline results obtained from a post-marketing clinical study, TWINKLE (TWYMEEG in diabetic patients with renal impairment: A post-marketing long-term study) (“the Study”), in Japanese type 2 diabetic patients with renal impairment for TWYMEEG Tablets 500 mg (generic name: imeglimin hydrochloride, “the Drug”) being sold in Japan, based on the Risk Management Plan. The Study was an open-label, uncontrolled, long-term study in 60 Japanese type 2 diabetic patients with renal impairment, who had no experience of type 2 diabetes treatment other than diet and exercise therapy or insufficient glycemic management in monotherapy with a hypoglycemic agent excluding insulin formulation. The Drugwas administered at 500 mg twice-daily to patients with moderate and severe renal impairment, characterized by an estimated glomerular filtration rate (eGFR) between 15 mL/min/1.73 m2 or higher to less than 45 mL/min/1.73 m2, or at 500 mg once-daily to patients with end-stage renal disease, characterized by an eGFR less than 15 mL/min/1.73m2, in monotherapy or in combination therapy with a hypoglycemic agent excluding insulin formulation, to evaluate safety and tolerability when administered orally for 52 weeks. The Drug was observed to be safe and well tolerated in Japanese type 2 diabetic patients with renal impairment and no significant differences were found in the incidence of adverse events, their types and severities in this study from previous clinical studies. Specifically, most of the adverse events were mild or moderate in severity. The incidence of serious adverse events was 16.7% (10 of 60 subjects) and causality with the Drug could be ruled out in all cases. Incidence of adverse events leading to study treatment discontinuation was also limited (4 of 60 subjects). At present, administration of the Drug is not recommended for patients with renal impairment with eGFR less than 45 mL/min/1.73m2. Based on the results of the Study, Sumitomo Pharma is planning to conduct discussions with the regulatory authorities in Japan, on revising the package insert in fiscal 20241 for patients with renal impairment with eGFR less than 45 mL/min/1.73m2. お知らせ • May 16
Poxel S.A., Annual General Meeting, Jun 21, 2023 Poxel S.A., Annual General Meeting, Jun 21, 2023, at 09:00 Central European Standard Time. Location: Mercure Hotel, Lyon Centre Saxe Lafayette, 29 rue de Bonnel, 69003 LYON, France. Lyon France