Tag Archives: Diabetes

Thoughts on SURMOUNT-MMO after SELECT Interim Analysis

At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.

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Under-DELIVERed: Results Parity for AZ at ESC

Results from AZ’s Ph3 DELIVER (Farxiga HF outcomes trial in HFpEF; press release) and new results from a pre-specified pooled analysis from the Ph3 DAPA-HF and DELIVER trials (press release) were presented at ESC 2022 and simultaneously published in the NEJM (view publication) and Nature Medicine (view publication), respectively. Of note, an 18% RRR was observed in the DELIVER primary composite endpoint (hHF+urgent hospitalization and CV death). Below, FENIX provides highlights, insights, and implications from DELIVER in the context of BI/Lilly’s EMPEROR-Preserved and the evolving CVRM global landscape.

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AZ to Initiate Ph2 Dapa + Zibotentan Trial in Cirrhosis; Esperion’s BA Included in ACC’s ECDP Guidelines

Two cardiometabolic-related news items have been observed: an AZ-sponsored Ph2 dapa + zibotentan combination trial in cirrhosis (ZEAL) has been observed (view CT.gov record); and Esperion announced the ACC’s ECDP guidelines now include bempedoic acid as an oral non-statin therapy to lower LDL-C. Below, FENIX provides context and insight on the respective news items.

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“Mass” Layoff at Beta Bionics?; Novo Initiates Ph3 Ozempic + Lower-Dose Glargine Trial; Novartis to Spin Off Sandoz; Lannett and Adocia CY Q2 ’22 Earnings Updates; Hygieia Appoints New CEO

A series of cardiometabolic-related updates have been observed: Beta Bionics has reportedly laid off an unknown number of employees (view LinkedIn post); a Novo-sponsored Ph3 trial evaluating Ozempic and lower-dose insulin glargine has been observed (SUSTAIN OPTIMIZE; view CT.gov record); Novartis announced plans to spin off Sandoz (press release); Lannett (press release) and Adocia (press release) released their Q2 ’22 earnings; and Hygieia announced the appointment of a new CEO. Below, FENIX provides context and insight on the respective news items.

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Xeris, Zealand, and MannKind Q2 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: Xeris Biopharma (press release), Zealand (press release; slides), and MannKind (press release; slides) hosted their Q2 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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FDA Detects Impurities in Samples of Merck’s Januvia; Senseonics and Ionis Q2 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: FDA’s website has been updated noting elevated levels of NTTP have been observed in samples of sitagliptin (view here); and Senseonics (press release) and Ionis (press release; slides) hosted their respective Q2 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Gan & Lee GZR4 IND Granted FDA Clearance; Viatris Q2 ’22 Earnings Update

Two cardiometabolic-related news items have been observed: Gan and Lee announced FDA accepted its IND application for a novel QW ultra-long-acting insulin (GZR4); and Viatris hosted its Q2 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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Novo Q2 ’22 London Earnings; Vertex and Amgen Q2 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q2 ’22 earnings (see previous FENIX insight on Q2 ’22 Novo earnings from August 3); Vertex (press release; slides), and Amgen (press release; slides) hosted their Q2 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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Insulet, Provention Bio, Bayer, and Regeneron Q2 ‘22 Earnings Updates; Abbott Partners with WeightWatchers

A series of cardiometabolic-related news items have been observed: Insulet (press release), Provention Bio (press release), Bayer (press release; slides), and Regeneron (press release; slides) hosted their respective earnings calls; and Abbott announced a partnership with WeightWatchers for Libre CGM data integration. Below, FENIX provides highlights and insights for the respective new items.

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Mounjaro Off to an Impressive Start; Lilly Q2 ’22 Earnings Update

Lilly hosted its Q2 ’22 earnings call (press release; slides) and provided updates across its CVRM portfolio. During the call, Lilly discussed the impressive Mounjaro launch trajectory, disclosed plans to initiate an H2H tirzepatide vs. Wegovy obesity trial (SURPASS 5), and reviewed other CVRM pipeline assets. Below, FENIX provides highlights and insights from the call, including a Mounjaro time-aligned launch analysis with Ozempic, Trulicity, Rybelsus, and Wegovy.

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