Category Archives: Topics

DELIVER Filed in US? August 2022 CHMP Agenda

The CHMP agenda for this month’s meeting (August 16-19) has been released and includes several cardiometabolic-related agenda items. Of note, the August CHMP meeting only has written procedures, not oral explanations. Notably, AZ’s Forxiga (dapagliflozin) has been filed for an indication extension based on the DELIVER HFpEF trial results. Below, FENIX provides highlights from the August 2022 CHMP agenda.

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Abbott Expands CGM Manufacturing Capacity; Dario and Embecta Q2 ‘22 Earnings Updates

Three cardiometabolic-related news items have been observed: Abbott reportedly plans to invest $450M to expand CGM manufacturing (view article); and Dario (press release) and Embecta (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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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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Tandem, Amarin, and Intercept Q2 ’22 Earnings Updates; Anthem to Cover Eversense E3 Implantable CGM

A series of cardiometabolic-related news items have been observed: Tandem (press release), Amarin (press release; slides), and Intercept (press release; slides) hosted their respective earnings calls; and Senseonics announced Anthem is now covering implantable CGMs, including Senseonics’s Eversense E3 CGM. Below, FENIX provides highlights and insights for the respective new items.

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SELECT Doesn’t Stop at Interim Analysis; Novo Nordisk Q2 ’22 Earnings Update

Novo Nordisk hosted its Q2 ’22 earnings call (press release; slides), which was ahead of the initially scheduled call on August 4. Of note, management disclosed that following an interim analysis, the DMC recommended SELECT CVOT (view CT.gov record) should continue in accordance with the trial protocol. Below, FENIX provides highlights and insights from the call.

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