Tag Archives: Diabetes

Medtronic CY Q3 ’21 (FY Q2 ’22) Earnings Update; HAGAR’s GWave Receives Breakthrough Device Designation; Oramed Randomizes 75% of Patients in Oral Insulin Trial; Beyond Type 1 Launches Web Platform in Arabic

A series of cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’21 (FY Q2 ’22) earnings call (press release; slides); HAGAR announced that its non-invasive CGM (GWave) has received Breakthrough Device Designation; Oramed announced it has enrolled and randomized 75% of the 675 T2DM patients in its Ph3 trial (ORA-D-013-1) evaluating its oral insulin; and Beyond Type 1 announced it has launched its web platform in Arabic. Below, FENIX provides highlights and insights for the respective new items.

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Intarcia Files Notice of Opportunity for a Hearing; Provention Bio Advances popPK Model for Teplizumab; Zealand Announces Dapiglutide Topline Results

Three cardiometabolic-related news items have been observed: It has been reported that Intarcia Therapeutics has filed for a Notice of Opportunity for a Hearing with FDA for ITCA-650 (link to WSJ article); Provention Bio announced topline results from preliminary analysis of popPK model; and Zealand announced topline results for Ph1b trial with GLP1-GLP2 dual receptor agonist (dapiglutide). Below, FENIX provides highlights and insights for the respective new items.

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Alnylam Hosts 2021 R&D Webinar

Alnylam hosted its 2021 R&D webinar (view here; slides) and discussed its 2022 product and pipeline goals, including CVRM assets. Below, FENIX provides highlights and insights from the Alnylam R&D event.

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Teladoc Hosts 2021 Investor Day; Better Therapeutics Pivotal BT-001 Trial for T2DM Completes Enrollment; Dario Announces New Employer Contracts

Three cardiometabolic-related news items have been observed: Teladoc Health hosted its 2021 Investor Day (view here; slides); Better Therapeutics announced the pivotal study evaluating the safety and efficacy of BT-001 for the treatment of T2DM has completed enrollment; and Dario announced it has entered into contracts with a national transportation employer for diabetes, and a regional employer for behavioral health. Below, FENIX provides highlights and insights for the respective new items.

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Novo to Acquire Dicerna

Novo Nordisk and Dicerna Pharmaceuticals announced they have entered into a definitive agreement under which Novo will acquire Dicerna for $3.3B. The $3.3B total is equal to $38.25 per share in cash and a premium of 80% to Dicerna’s closing price on November 17, 2021. The transaction is expected to close in Q4 ’21. Below, FENIX provides thoughts on the acquisition, including insight into Novo’s potential motivations and the impact on Dicerna’s existing partners (e.g. Lilly and BI).

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Viatris/Biocon Launch Interchangeable Semglee in US; Lexicon Presents SOLOIST/SCORED Renal Subcuts at AHA; CRISPR/ViaCyte to Initiate Ph1 Trial in T1DM; Innovation Zed Announces InsulCheck DOSE 2022 Launch; Nemaura and Dario Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from Viatris/Biocon, Lexicon, CRISPR Therapeutics/ViaCyte, Innovation Zed, Nemaura Medical, and Dario Health. Below, FENIX provides highlights and insights for the respective news items.

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Bayer Hosts Kerendia Investor Webinar

Bayer hosted its Kerendia (finerenone) investor webinar (view here), highlighting Kerendia’s clinical profile, how it fits into the treatment landscape, US market strategy, and LCM initiatives. Unsurprisingly, much of the event, including the Q&A, focused on the differentiation with the SGLT2i class. Separately, Bayer announced the initiation of a new Ph3 trial (FIONA) evaluating finerenone in pediatrics with CKD and severely increased proteinuria. Below, FENIX provides highlights from the presentation as well as additional thoughts on the Kerendia launch.

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Novo’s High-Dose Ozempic Receives Positive CHMP Opinion; Movano Q3 ’21 Earnings Update

Two cardiometabolic-related news items have been observed: Novo Nordisk announced that its high-dose Ozempic (2.0mg semaglutide) has received a positive CHMP opinion and Movano hosted its Q3 ’21 earnings call (press release; view Movano website). Below, FENIX provides highlights and insights from the respective news items.

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