Tag Archives: imeglimin

Biocon/Viatris Bs-aspart and Xeris RTU Glucagon Receive EC Approval; Poxel Q4 and FY ’20 Earnings Update

A series of cardiometabolic-related news items have been observed: Biocon/Viatris announced EC approval for their rapid-acting bs-insulin aspart, branded as Kixelle; Xeris announced it received EC approval for its RTU rescue glucagon product, branded as Ogluo; and Poxel announced its Q4 and FY ’20 earnings. Below, FENIX provides highlights and insights for the respective news items.

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Imeglimin Ph3 US and EU Development Discontinued by Metavant; Poxel Seeks Other Options

Poxel announced that Metavant, its US and EU development partner for Imeglimin, has decided not to move Imeglimin into Ph3 trials. Recall, in Poxel’s Q3 ’20 earnings update, Poxel disclosed that Metavant was in discussions with FDA regarding the Imeglimin Ph3 program in patients with T2DM and stage 3b or 4 CKD (previous FENIX insight). Below, FENIX provides thoughts on the future of Imeglimin in Western markets.

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Dexcom Partners with UVA, Novo CVD Real-world Treatment Study, Movano Partners for Smartwatch CGM; Imeglimin Ph3 Data; EASD 2020 Key Press Releases (Sept 24)

On Day 4 of EASD 2020, four key press releases were observed from Dexcom, Novo Nordisk, Movano, and Poxel. Below, FENIX provides insights and context from each respective announcement, including what could be behind the scenes in the Dexcom-UVA research partnership.

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Japanese NDA Submitted for Imeglimin; Poxel H1 ’20 Earnings Update

Yesterday, Poxel hosted its H1 ’20 earnings call and provided updates to its Japanese and US Imeglimin development. Of note, Poxel has submitted the Japanese NDA for Imeglimin and its US partner, Metavant, is actively preparing to initiate a Ph3 program in the US. Below, FENIX provides an overview of the Poxel earnings call and thoughts on Imeglimin development, including its market potential.

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Poxel Reports Positive Imeglimin Ph3 Japan Topline Results

Poxel announced positive topline results from the Imeglimin Ph3 (TIMES 3) 36-week open-label extension which evaluated the drug in Japanese patients with T2DM. Following the announcement, Poxel hosted a conference call to discuss the results. The company continues to state that it plans to file a Japanese NDA in 2020. Below, FENIX provides an overview of the Imeglimin Ph3 topline results as well as analysis of the market potential for Imeglimin in Japan.

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Poxel Ph3 Imeglimin and vTv Ph2 TTP399 CGM Data; EASD 2019 Day 3

On the third day of EASD, 2 key press releases and one new clinical trial were observed. Of note, results from Novo Nordisk’s H2H Tresiba vs. Toujeo trial (CONCLUDE) were presented but a Novo press release was not observed. There is a dedicated session on CONCLUDE tomorrow (September 19) from 12-1pm local time. Below FENIX provides insights and context from each respective announcement.

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