Category Archives: Topics

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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UPDATED: Finerenone US Launch Analysis

Ahead of Bayer’s Kerendia (finerenone) investor webinar on Monday, November 15 @ 9 AM ET (view link to webcast), FENIX has conducted a follow-on launch analysis. In case you missed it, FENIX performed an early Kerendia launch and HCP website analysis in October 2021 (previous FENIX insight). Below, FENIX provides an analysis of the developing Kerendia Rx data, including a time-aligned launch comparison with other key brands to see if Kerendia’s launch is more like Entresto or Brilinta.

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BI/Lilly’s Jardiance Receives FDA Priority Review; Novo’s Wegovy Receives Positive CHMP Opinion; Merck/Bayer Initiate New Ph3 Verquvo Study; Dario Enters Three New Commercial Agreements; Gmax Administers First in Human Dose of GMA106 in Ph1 Obesity Study; Metacrine and Zealand Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Novo Nordisk, Zealand, Merck/Bayer, Dario, Gmax Biopharma, and Metacrine. Below, FENIX provides highlights and insights for the respective news items, including an updated projection of the EMPEROR-Preserved PDUFA date.

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Bayer and Senseonics Q3 ’21 Earnings Updates; Abbott and ADA Launch Community Initiative; Provention Bio Launches #Type1TestedPledge Campaign; Beyond Type 1 Receives $750,000 Grant

A series of cardiometabolic-related news items have been observed: Bayer (press release; slides) and Senseonics (press release) hosted their respective Q3 ’21 earnings calls; Abbott and the American Diabetes Association (ADA) announced the launch of their first joint community initiative in Columbus, Ohio; Provention Bio announced the launch of its #Type1TestedPledge Campaign for Diabetes Awareness Month; and Beyond Type 1 announced it has received a $750,000 Grant from the Helmsley Charitable Trust. Below, FENIX highlights and insights for the respective new items.

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November 8-11 CHMP Agenda; Kerendia+SGLT2i Reduce Risk of Composite CV Outcome; Viatris Q3 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (November 8-11) has been released; Bayer announced positive results from an additional sub-analysis from the Ph3 FIDELITY trial demonstrating Kerendia (finerenone) in conjunction with SGLT2i reduced the risk of the composite CV outcome; and Viatris hosted its Q3 ’21 earnings call (press release; slides). Below, FENIX highlights and insights for the respective new items.

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GSK’s Daprodustat Ph3 Data Positive But Not Entirely Clean; BI/Lilly’s Jardiance Demonstrates Consistent Cardio-Renal Benefits in HF; Novo Announces Positive Ph3b STEP 5 Trial Results; CytoDyn Reports Positive Preliminary Data from Ph2 Leronlimab Trial; Roche and Sanofi Mallya Collaboration; Intuity Medical’s Automatic BGM Available in US; Zealand and DEKA Collaboration for Continuous Infusion Pump

A series of cardiometabolic-related news items have been observed from GSK, BI/Lilly, Novo Nordisk, CytoDyn, Roche, Intuity Medical, and Zealand. Below, FENIX provides highlights and insights for the respective news items.

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Viatris’s Semglee Gains Preferred Status on Prime Therapeutics’s National Formularies; Zealand’s First Patient Dosed with ZP8396 in Ph1 Trial for Obesity; Insulet, Lannett, Ionis, Provention Bio, BD, and Regeneron Q3 ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed from Prime Therapeutics, Zealand, Lannett, Ionis, Provention Bio, Becton Dickinson, Regeneron, and Dario. Below, FENIX provides highlights and insights for the respective news items.

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