Tag Archives: Diabetes

SURPASS-4 Data Continue to Impress; Arecor and Lilly Partnership

Two diabetes-related news items have been observed: Lilly announced positive topline results from the Ph3 SURPASS-4 trial comparing tirzepatide to insulin glargine in patients with T2DM and an increased CV risk; and Arecor announced it has signed a formulation study partnership with Lilly, in which Arecor will use its proprietary tech platform Arestat for “one of Lilly’s proprietary products intended for self-administration.” Below, FENIX provides highlights and insights from the respective news items.

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Roche Launches Smartphone-controlled Pump; Metronom Enters CGM JV in China; FDA Draft Guidance on T2DM Glycemic Control Devices; Dario Q1 ’21 Earnings Update; New Ascensia BGM Portal; Metacrine Ph2 NASH Trial

A series of cardiometabolic news items have been observed: Roche announced the launch of its mySugr Pump Control smartphone app; Dinova Medtech and Metronom Health have created a joint venture in China for CGM development and commercialization; FDA issued a draft guidance on medical devices intended to improve glycemic control in T2DM; Dario hosted its Q1 ’21 earnings call; Ascensia announced the launch of the new “GlucoContro.online” patient and provider portal for diabetes management and analytics; and Metacrine has enrolled the first 60 patients in its MET642 Ph2a NASH trial. Below, FENIX provides highlights and insights from the respective news items.

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Novo’s Ph2 Ziltivekimab Data @ ACC 2021; Sheldon Koenig Takes Over as Esperion CEO; New T1DM Treatment from Neurodon

A series of cardiometabolic news items have been observed: full results from Novo Nordisk’s Ph2 ziltivekimab were presented at ACC 2021; Sheldon Koenig was appointed as Esperion’s new President and CEO; and Neurodon is initiating IND-enabling studies for its novel T1DM therapeutic. Below, FENIX provides highlights and insights from the respective news items.

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Zealand Q1 ’21 Earnings Update

Zealand hosted its Q1 ’21 earnings call and provided updates to its business, including the impending US launch of Zegalogue in mid- to late-June as well as other pipeline updates. Below, FENIX provides highlights and insights from the call.

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DAPA-CKD Label Analysis; Farxiga Websites Updated

In late April 2021, FDA approved Farxiga for the treatment of CKD. The approval was based on results from the DAPA-CKD Ph3 trial which demonstrated a highly impressive 39% RRR in the primary composite endpoint (sustained ≥50% decline in eGFR, ESKD, renal death, or CV death; previous FENIX insight). Below, FENIX provides thoughts on the new Farxiga CKD indication, including read-through to finerenone, sotagliflozin, Jardiance and the rest of the SGLT2i class.

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Lilly Obesity Ph2 GGG Tri-agonist Trial; Novo QW Icodec Ph3 T2DM; Sigilon Q1 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for a Ph2 Lilly-sponsored trial investigating QW LY3437943 (GGG tri-agonist) in obesity has been observed; a CT.gov record for Novo Nordisk’s Ph3 QW insulin icodec T2DM trial (ONWARDS 4) has been observed; and Sigilon announced its Q1 ’21 earnings, though it did not provide a development update on SIG-002 nor did it host an associated webcast. Below, FENIX provides highlights and insights for the respective news items.

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Bigfoot Unity Receives 510(k) Clearance; Bayer’s FIGARO-DKD Meets Primary Endpoint; Viatris Q1 ’21 Earnings Update; Novo Insulin Product Samples Recalled

A series of cardiometabolic-related news items have been observed: Bigfoot announced FDA granted 510(k) clearance for its Bigfoot Unity Diabetes Management System which features connected smart pen caps integrated with Abbott’s Libre 2 CGM; Bayer announced the Ph3 FIGARO-DKD CVOT evaluating finerenone in ~7,400 adults with CKD and T2DM has met its primary endpoint; Viatris hosted its Q1 ’21 earnings call; and Novo Nordisk announced a voluntary recall of 1,468 Levemir, Tresiba, Fiasp, Novolog, and Xultophy product samples due to improper storage temperature conditions. Below, FENIX provides highlights and insights for the respective news items.

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Omnipod 5 Delayed; Insulet and Lexicon Q1 ’21 Earnings Updates

Lexicon (press release) and Insulet (press release) hosted their Q1 ’21 earnings calls and provided updates to their respective businesses. Importantly, Insulet disclosed there will be a delay to the Omnnipod 5 approval due to the COVID-mediated constraints within FDA. Below, FENIX provides highlights and insights from the calls.

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